6 January 2025

EMA/135580/2012
Information Management

Detailed guidance on the electronic submission of

information on medicinal products for human use by
marketing authorisation holders to the European
Medicines Agency in accordance with Article 57(2) of
Regulation (EC) No. 726/2004
Chapter 3.II: XEVPRM User Guidance

Version 3.18

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© European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged.
Version number: Published: Date of coming into force:

Version 3.18 January 2025 13 January 2025

Version 3.17 22 July 2024 22 July 2024

Version 3.16 18 January 2024 18 January 2024

Version 3.15 5 July 2023 1 July 2023

Version 3.14 September 2021 13 September 2021

Version 3.13 July 2018 26 July 2018

Version 3.12 24 April 2017 1 May 2017

Version 3.11 11 February 2016 11 February 2016

Version 3.10 20 January 2016 20 January 2016

Version 3.9 19 November 2015 23 November 2015

Version 3.8 19 May 2015 1 May 2015

Version 3.7 22 December 2014 16 June 2014

Version 3.6 8 July 2014 16 June 2014

Version 3.5 16 June 2014 16 June 2014

Version 3.4 5 March 2014 16 June 2014

Version 3.3 28 February 2014 16 June 2014

Version 3.2 31 January 2014 16 June 2014

Version 3.1 17 January 2013 1 February 2013

Version 3.0 5 March 2012 20 March 2012

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 2/200
Table of contents
Summary of changes ................................................................................... 9
Introduction .............................................................................................. 10
Background information ............................................................................ 11
eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) schema ............... 13
XEVMPD user interface (EVWEB) ............................................................................... 13
Available operation types to be used in an XEVPRM ..................................................... 13
XEVPRM Acknowledgements ..................................................................................... 14

1. Initial submission of medicinal product data ......................................... 15

1.1. Initial submission of an authorised medicinal product (AMP) entity .......................... 15
Table 1a- Authorised medicinal product – language requirements .................................. 21
1.1.1. Submission of information for medicinal products authorised in EEA countries outside
the EU .................................................................................................................. 22
1.1.1.1. Submission of information for medicinal products authorised in Liechtenstein ...... 22
1.1.2. Submission of information for medicinal products authorised outside the EU/EEA .... 23
Table 1b - Requirements for AMP records and attachments for countries with more than one
national language ................................................................................................... 23
Table 2 - Art 57(2) data element requirements overview for authorised medicinal product
submission ............................................................................................................ 25
1.2. Authorised medicinal product - element structure ................................................. 34
1.2.1. Local Number (AP.1) ...................................................................................... 35
1.2.2. EV Code (AP.2) ............................................................................................. 36
1.2.3. New Owner ID (AP.3) ..................................................................................... 36
1.2.4. Marketing authorisation holder (MAH) code (AP.4) ............................................. 36
NOTE 1 ................................................................................................................. 37
1.2.5. Qualified Person responsible for Pharmacovigilance (QPPV) code (AP.5) ................ 37
1.2.6. Pharmacovigilance System Master File Location (PSMFL) code (AP.6) .................... 38
1.2.7. Pharmacovigilance enquiry email (AP.7) ........................................................... 38
1.2.8. Pharmacovigilance enquiry phone (AP.8) .......................................................... 39
1.2.9. Sender local code (AP.9) ................................................................................ 39
1.2.10. Info date format (AP.10)............................................................................... 39
1.2.11. Info date (AP.11) ......................................................................................... 39
1.2.12. AMP - Authorisation details element structure (AP.12)....................................... 40
1.2.12.1. Authorisation country code (AP.12.1) ........................................................... 40
NOTE 2 ................................................................................................................. 41
1.2.12.2. Authorisation procedure (AP.12.2) ............................................................... 41
NOTE 3 ................................................................................................................. 43
1.2.12.3. Authorisation status (AP.12.3) .................................................................... 43
NOTE 4 ................................................................................................................. 44
1.2.12.4. Authorisation number (AP.12.4) .................................................................. 45
1.2.12.5. Authorisation/renewal date (AP.12.5) .......................................................... 47
1.2.12.6. Authorisation/renewal date format (AP.12.6) ................................................ 48
1.2.12.7. MRP/DCP/EMEA number (AP.12.7)............................................................... 48
1.2.12.8. EU number (AP.12.8) ................................................................................ 50
Detailed guidance on the electronic submission of information on medicinal products
for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 3/200
1.2.12.9. Orphan drug status (AP.12.9) ..................................................................... 50
1.2.12.10. Additional monitoring (AP.12.10) ............................................................... 50
1.2.12.11. Invalidated date format (AP.12.11) ............................................................ 50
1.2.12.12. Invalidated date (AP.12.12) ...................................................................... 51
1.2.12.13. Legal basis (AP.12.13) ............................................................................. 51
NOTE 5 ................................................................................................................. 52
NOTE 6 ................................................................................................................. 52
1.2.12.14. Medicinal product types (AP.12.MPT.1) ....................................................... 53
1.2.13. AMP - Presentation Name element structure (AP.13) ......................................... 53
1.2.13.1. Full Presentation Name (AP.13.1) ................................................................ 55
1.2.13.2. Product Short Name (AP.13.2) .................................................................... 55
1.2.13.3. Product INN/Common Name (AP.13.3) ......................................................... 57
1.2.13.4. Product Company Name (AP.13.4)............................................................... 60
1.2.13.5. Product Strength Name (AP.13.5) ............................................................... 61
1.2.13.6. Product Form Name (AP.13.6) .................................................................... 63
1.2.14. Authorised pharmaceutical form (AP.APF.1) ..................................................... 66
NOTE 7 ................................................................................................................. 67
NOTE 8 ................................................................................................................. 68
1.2.15. Package description (AP.13.7) ....................................................................... 68
1.2.16. Comment (AP.14) ........................................................................................ 69
1.2.17. AMP - Pharmaceutical product elements (AP.PPs) ............................................. 70
1.2.17.1. Administrable pharmaceutical form (PP.1) .................................................... 80
Process map 1 – Referencing a pharmaceutical form in a pharmaceutical product section of
an AMP ................................................................................................................. 82
1.2.17.2. Administration route (PP.AR.1) ................................................................... 82
Process map 2 – Referencing a route of administration in a pharmaceutical product section
of an AMP .............................................................................................................. 84
1.2.17.3. Pharmaceutical product drug ingredients and medical device(s) ....................... 85
NOTE 9 ................................................................................................................. 88
NOTE 10 ............................................................................................................... 89
1.2.17.4. Active ingredient substance code (PP.ACT.1) ................................................. 90
Table 3 - Requirements on how to reflect information on substance and strength in section
2. Qualitative and Quantitative Composition of the SmPC ............................................. 92
1.2.17.5. Active ingredient substance strength ........................................................... 94
NOTE 11 ............................................................................................................... 95
NOTE 12 ............................................................................................................... 95
1.2.17.6. Active ingredient concentration type Code (PP.ACT.2) .................................... 95
1.2.17.7. Active ingredient substance value(s) ............................................................ 96
1.2.17.8. Excipient substance code (PP.EXC.1) .......................................................... 100
1.2.17.9. Excipient substance strength ..................................................................... 101
1.2.17.10. Adjuvant substance code (PP.ADJ.1) ......................................................... 102
1.2.17.11. Adjuvant substance strength.................................................................... 102
1.2.17.12. Medical device Code (PP.MD.1) ................................................................ 103
1.2.18. Product ATC Code(s) (AP.ATC.1) ................................................................... 103
1.2.19. AMP - Product indications (AP.INDs) .............................................................. 104
1.2.19.1. MedDRA version (AP.IND.1) ...................................................................... 105

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 4/200
1.2.19.2. MedDRA level (AP.IND.2) .......................................................................... 105
1.2.19.3. MedDRA Code (AP.IND.3).......................................................................... 105
Additional MedDRA coding examples ........................................................................ 107
1.2.20. Previous EV Code (AP.PEV.1) ........................................................................ 108
1.2.21. AMP - Printed product information (PPI) attachments ....................................... 109
1.2.21.1. Attachment EV Code (AP.PPI.1) ................................................................. 109
NOTE 13 .............................................................................................................. 110
1.2.21.2. Attachment validity declaration (AP.PPI.2) ................................................... 110
1.3. Initial submission of a QPPV information ............................................................. 111
1.4. Initial submission of an approved substance........................................................ 113
1.5. Initial submission of a reference source .............................................................. 115
1.5.1. Local Number (S.1) ...................................................................................... 115
1.5.2. EV Code (S.2) .............................................................................................. 116
1.5.3. Reference source name (S.3) ......................................................................... 116
1.5.4. Comment (S.4) ............................................................................................ 116
1.6. Initial submission of a marketing authorisation holder (MAH) organisation ............... 118
NOTE 14 .............................................................................................................. 118
Table 4 - Art 57(2) data elements requirements overview for MAH organisation submission
.......................................................................................................................... 122
1.6.1. Type of organisation (O.1) ............................................................................. 122
1.6.2. Organisation name (O.2) ............................................................................... 123
1.6.3. Local Number (O.3) ...................................................................................... 123
1.6.4. EV Code (O.4).............................................................................................. 124
1.6.5. Organisation Sender Identifier (O.5) ............................................................... 124
1.6.6. Address (O.6) .............................................................................................. 124
1.6.7. City (O.7) .................................................................................................... 124
1.6.8. State (O.8) .................................................................................................. 124
1.6.9. Postcode (O.9) ............................................................................................. 124
1.6.10. Country Code (O.10) ................................................................................... 124
1.6.11. Telephone number (O.11)/Extension (O.12)/Country Code (O.13) ..................... 125
1.6.12. Fax number (O.14)/Extension (O.15)/Country Code (O.16) .............................. 125
1.6.13. Email address (O.17) .................................................................................. 125
1.6.14. Comment (O.18) ........................................................................................ 125
1.6.15. SME status (O.19) ...................................................................................... 125
1.6.16. SME number (O.20) .................................................................................... 126
1.7. Initial submission of an ATC Code ...................................................................... 128
1.7.1. Type Term (ST.ATC.1) .................................................................................. 131
1.7.2. ATC Code (ST.ATC.2) .................................................................................... 131
1.7.3. New owner ID (ST.ATC.3) .............................................................................. 131
1.7.4. ATC Code description (ST.ATC.4) .................................................................... 131
1.7.5. Version Date Format (ST.ATC.5) ..................................................................... 131
1.7.6. Version Date (ST.ATC.6)................................................................................ 132
1.7.7. Comment (ST.ATC.7) .................................................................................... 132
1.8. Initial submission of an authorised/administrable pharmaceutical form ................... 133
1.8.1. Type Term (ST.PF.1) ..................................................................................... 134
1.8.2. Local Number (ST.PF.2)................................................................................. 134
Detailed guidance on the electronic submission of information on medicinal products
for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 5/200
1.8.3. EV Code (ST.PF.3) ........................................................................................ 135
1.8.4. New owner ID (ST.PF.4) ................................................................................ 135
1.8.5. Name of the Pharmaceutical Form (ST.PF.5)..................................................... 135
1.8.6. Version Date Format (ST.PF.6) ....................................................................... 136
1.8.7. Version Date (ST.PF.7) .................................................................................. 136
1.8.8. Previous EV Code (ST.PF.8) ........................................................................... 136
1.8.9. Comment (ST.PF.9) ...................................................................................... 136
1.9. Initial Submission of a route of administration (RoA) ............................................ 137
1.9.1. Type Term (ST.AR.1) .................................................................................... 138
1.9.2. Local Number (ST.AR.2) ................................................................................ 138
1.9.3. EV Code (ST.AR.3) ....................................................................................... 139
1.9.4. New owner ID (ST.AR.4) ............................................................................... 139
1.9.5. Name of the Route of Administration (ST.AR.5) ................................................ 139
1.9.6. Version Date Format (ST.AR.6) ...................................................................... 140
1.9.7. Version Date (ST.AR.7) ................................................................................. 140
1.9.8. Previous EV Code (ST.AR.8) ........................................................................... 140
1.9.9. Comment (ST.AR.9)...................................................................................... 140
1.10. Submission of an attachment .......................................................................... 141
NOTE 15 .............................................................................................................. 142
1.10.1. Local number (ATT.1) .................................................................................. 146
1.10.2. File name (ATT.2) ....................................................................................... 146
1.10.3. File type (ATT.3) ........................................................................................ 147
1.10.4. Attachment name (ATT.4) ............................................................................ 147
1.10.5. Attachment type (ATT.5) ............................................................................. 147
1.10.6. Language code (ATT.6)................................................................................ 147
1.10.7. 2nd Language code (ATT.7)........................................................................... 147
1.10.8. Attachment version (ATT.8) ......................................................................... 148
1.10.9. Attachment version date (ATT.9) .................................................................. 148
1.10.10. Version date format (ATT.10) ..................................................................... 148
1.11. Initial submission of a Pharmacovigilance System Master File (PSMF) information ... 149
Table 5 – Requesting a single/multiple PSMF EV Code(s) by the same MAH .................... 150
Table 6 – Requesting a single/multiple PSMFL EV Code(s) by different MAHs .................. 151
1.11.1. Local Number (MF.1) ................................................................................... 153
1.11.2. EV Code (MF.2) .......................................................................................... 154
1.11.3. Pharmacovigilance System Master File Company (MF.3) ................................... 154
1.11.4. Pharmacovigilance System Master File Department (MF.4)................................ 154
1.11.5. Pharmacovigilance System Master File Building (MF.5) ..................................... 154
1.11.6. Pharmacovigilance System Master File Street (MF.6) ....................................... 155
1.11.7. Pharmacovigilance System Master File City (MF.7) ........................................... 155
1.11.8. Pharmacovigilance System Master File State (MF.8) ......................................... 155
1.11.9. Pharmacovigilance System Master File Postcode (MF.9) .................................... 155
1.11.10. Pharmacovigilance System Master File Country code (MF.10) .......................... 155
1.11.11. Comment (MF.11) ..................................................................................... 155

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 6/200
2. Maintenance of medicinal product data ............................................... 156
Scope and objectives ............................................................................... 156
Transition maintenance phase - Electronic submission plan .................... 157
2.1. Maintenance of a Qualified Person responsible for Pharmacovigilance (QPPV) ........... 160
2.1.1. Business process to notify the change of QPPV's details ..................................... 160
Process map 3 – Change of QPPV's details................................................................. 161
2.1.2. Business process to notify a change of a QPPV .................................................. 161
Process map 4 – Change of a QPPV .......................................................................... 163
2.2. Maintenance of a marketing authorisation holder (MAH) organisation entity ............. 165
2.2.1. Notification of change of contact details, name and/or address of the MAH (i.e., no
change of the legal entity) ...................................................................................... 165
2.2.2. Notification of transfer of marketing authorisation (i.e., change of the legal entity) 165
Process maps 5 – Change of MAH details .................................................................. 167
Process map 6 – Notifying an MAH entity as 'non-current' ........................................... 168
2.3. Maintenance of a Pharmacovigilance System Master File Location (PSMFL) entity ..... 170
Process map 7 – Change of PSMF information ............................................................ 172
Process map 8 – Notifying a PSMFL entity as 'non-current' .......................................... 173
2.4. Maintenance of an authorised medicinal product (AMP) entity ................................ 175
Process map 9 – Business processes to amend medicinal product information in the XEVMPD
following a regulatory procedure .............................................................................. 176
Process map 10 – Amendment of an AMP entity ......................................................... 177
2.4.1. Variations of marketing authorisation .............................................................. 178
2.4.1.1. Business process - Authorisation number has changed following a variation ....... 183
2.4.1.2. Business process - Authorisation number has not changed following a variation .. 183
2.4.2. (Lifting of) suspension of marketing authorisation ............................................. 184
2.4.3. Transfer of marketing authorisation ................................................................ 184
2.4.3.1. Transfer of marketing authorisation between organisations registered in
EudraVigilance under separate headquarters ............................................................. 184
2.4.3.2. Transfer of marketing authorisation between organisations registered in
EudraVigilance under the same headquarter .............................................................. 186
Process map 11 – Transfer of marketing authorisation ................................................ 188
2.4.4. Renewal of marketing authorisation ................................................................ 191
2.4.4.1. Business process - Authorisation number has not changed following a renewal ... 191
2.4.4.2. Business process - Authorisation number has changed following a renewal ........ 191
Process map 12 – Renewal of marketing authorisation ................................................ 192
2.4.5. Change of authorisation procedure following a referral ....................................... 192
2.4.6. Revocation/withdrawal/expiry of marketing authorisation ................................... 192
2.4.7. Nullification of AMP entities ............................................................................ 193
Process map 13 – Nullification of an AMP entity.......................................................... 194
2.5. Nullification of XEVMPD entities ......................................................................... 195
Process map 14 – Nullification of XEVMPD entities ...................................................... 196

Annex I: Pack size submissions ............................................................... 197

Annex II: XEVMPD submission contact points ......................................... 199

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 7/200
Detailed guidance on the electronic submission of information on medicinal products
for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 8/200
Summary of changes
Following the publication of version 3.17 in July 2024 the content of the below listed sections was
amended; the changes are highlighted in red and strikethrough text:

• Background information

• 1.2.12.3. Authorisation status (AP.12.3)

• 1.2.12.4. Authorisation number (AP.12.4)

• 1.2.15. Package description (AP.13.7)

• NOTE 9

• NOTE 10

• 1.2.17.4. Active ingredient substance code (PP.ACT.1)

• 1.2.17.5. Active ingredient substance strength

• NOTE 12

• 1.2.17.7. Active ingredient substance value(s)

• 1.2.17.8. Excipient substance code (PP.EXC.1)

• 1.2.17.9. Excipient substance strength

• 1.2.17.10. Adjuvant substance code (PP.ADJ.1)

• 1.2.17.11. Adjuvant substance strength

• 1.2.21. AMP - Printed product information (PPI) attachments

• 1.6. Initial submission of a marketing authorisation holder (MAH) organisation

• NOTE 14

• 1.10. Submission of an attachment

• 2.4.3.1. Transfer of marketing authorisation between organisations registered in EudraVigilance

under separate headquarters

• Process map 11 – Transfer of marketing authorisation

• Annex II: XEVMPD submission contact points – new section

Please note that editorial changes of this document are not included in the summary of changes.

Please also note that the implementation of a new authorisation status value ‘Valid – pending national
phase’, which was foreseen to be made available in the XEVMPD in Q1/2024, as per the XEVMPD
webinar in October 2023, has been deferred. This is because the data of nationally authorised
medicinal products will not be released in the PLM portal before Q4 2024, as per information in this
presentation. Therefore, there is currently no need for MAHs to submit information on pending
nationally authorised medicinal products to XEVMPD. For this reason, no information related to the use
of this authorisation status value is included in this version of this document.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 9/200
Introduction
This document provides user guidance on:

• the data elements to be completed for the electronic submission of information on medicinal
products for human use authorised in the European Economic Area (EEA) using the eXtended
EudraVigilance Medicinal Product Report Message (XEVPRM);

• the maintenance of medicinal product data previously submitted.

The data elements for medicinal products are based on the following reference information:

• the Summary of Product Characteristics (SmPC), which serves the purpose of validation of the
information provided in the structured data elements:

− Section 1. Name of the medicinal product,

− Section 2. Qualitative and quantitative composition,

− Section 3. Pharmaceutical Form,

− Section 4.1 Therapeutic indications,

− Section 4.2 Posology and method of administration,

− Section 5.1 Pharmacodynamic properties,

− Section 6.1 List of excipients,

− Section 6.5 Nature and contents of container,

− Section 7. Marketing Authorisation Holder,

− Section 8. Marketing Authorisation Number,

− Section 9. Date of first authorisation/renewal of the authorisation,

− Section 10. Date of revision of the text;

• The medicinal product authorisation information (as referred to in the Legal Notice on the
Implementation of Article 57(2) of Regulation (EC) No. 726/2004 published by the Agency);

• The pharmacovigilance information (as referred to in the Legal Notice on the Implementation of
Article 57(2) of Regulation (EC) No. 726/2004 published by the Agency).

All medicinal product names/marketing authorisation holder names used in this document
are fictitious and were created for the purposes of being used as examples in this user
guidance.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 10/200
Background information
New pharmacovigilance legislation (Regulation (EU) No 1235/2010 amending Regulation (EC) No
726/2004 and Directive 2010/84/EU amending Directive 2001/83/EC) was adopted by the European
Parliament and European Council in December 2010. The legislation was the biggest change to the
regulation of human medicines in the European Union (EU) since 1995. It had significant implications
for applicants and holders of EU marketing authorisations. The European Medicines Agency (EMA) was
responsible for implementing much of the new legislation and developed a framework for compliance
and delivery of key requirements. The legislation applies from July 2012.

One of the key deliverables of the new legislation related to the submission of medicinal product
information by marketing authorisation holders to the European Medicines Agency. Article 57(2) of
Regulation (EC) No 726/2004, as amended by Regulation (EU) 1235/2010 and Regulation (EU)
1027/2012, requires:

• the Agency to publish the format for the electronic submission of information on medicinal products
for human use by 2 July 2011;

• marketing authorisation holders to submit information to the Agency electronically on all medicinal
products for human use authorised in the European Union by 2 July 2012, using this format;

• marketing authorisation holders to inform the Agency of any new or varied marketing
authorisations granted in the EU as of 2 July 2012, using this format.

Marketing authorisation holders are also required to submit information concerning all medicinal
products for which they hold a marketing authorisation in EEA countries outside the EU (i.e., Iceland,
Liechtenstein, and Norway), as the pharmacovigilance legislation has been incorporated into the EEA
Agreement and entered into force in the EEA on 28 May 2014.

From 1 January 2021, the United Kingdom is considered a non-EU/EEA country. Based on the Protocol
on Ireland/Northern Ireland, EU pharmaceutical law applies to and in the UK in respect of Northern
Ireland only, as of 1 January 2021, to the extent described in the Protocol. Therefore, information on
medicinal products for human use, for which the marketing authorisation granted by the UK national
authority is valid in the territory of Northern Ireland, must be submitted in the Article 57 database as
per Article 57(2) legal obligations:

• the country of authorisation in the product entries in the Article 57 database must be specified as
‘United Kingdom (Northern Ireland) (XI)’;

• an EU authorisation procedure (e.g., national, decentralised, mutual recognition procedure) must

be referenced as applicable.

In accordance with the information provided section 4. The location of the marketing authorisation
holder and the qualified persons for manufacturing for pharmacovigilance with regard to medicinal
products for human use of the Commission Notice – Application of the Union’s pharmaceutical acquis in
markets historically dependent on medicines supply from or through parts of the United Kingdom other
than Northern Ireland:

• The MAH may be established in an EU member state, NO, LI, IS, XI or GB.

• The QPPV and PSMF may be established in an EU member state, NO, LI, IS, XI or in the rest of
the United Kingdom (GB), if the organisation does not already have a QPPV based in the EEA or
Northern Ireland.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 11/200
In March 2024, the EU-UK Joint Committee adopted a decision laying down the arrangements relating
to the Windsor Framework, which adjusts the Protocol on Ireland/Northern Ireland. With regards to the
information in Article 57 database, Regulation (EU) 2023/1182 will only impact medicinal products
authorised by the European Commission under the centralised procedure. There is no change
in the submission requirements of information for medicinal products approved nationally
(i.e. via a national procedure, mutual recognition procedure and/or decentralised procedure) by the
MHRA and with marketing authorisation valid in the territory of Northern Ireland when Regulation (EU)
2023/1182 becomes applicable. After the date on which Regulation (EU) 2023/1182 become
applicable, marketing authorisation holders should therefore continue to report product information on
medicinal products authorised nationally (i.e. via national, decentralised, mutual recognition
procedure) with a marketing authorisation valid in Northern Ireland as today.

See section 8. Changes required in the Article 57 database of the 'Questions and answers to
Stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal
products for human use: Practical guidance on the applicable rules to centrally authorised medicinal
products for human use intended to be placed on the market in Northern Ireland before and after the
application of Regulation (EU) 2023/1182' document for related information.

Medicinal products falling out of scope of Article 57(2) of Regulation (EC) No 726/2004 legal
obligations include:

• investigational medicinal products;

• products for which the marketing authorisation is not valid;

• traditional use registration application for herbal medicinal products (Article 16a of Directive No
2001/83/EC)1;

• simplified registration application for a homeopathic medicinal products (Article 14 of Directive No

2001/83/EC)1;

• medicinal products within the scope of Article 5 of Directive 2001/83/EC i.e., 'Named patient use'
falling under Article 5(1) and 'EU Distribution Procedure' under Article 5(2);

• parallel Distributed/Imported medicinal products (Article 76(3) and (4) of Directive No

2001/83/EC);

• medicinal products authorised outside the EEA or following a non-EU procedure.

Medicinal products falling out of scope of Article 57(2) legal obligation may be submitted on voluntary
basis in line with the requirements and business processes described in this guidance.

The web-based eAF is consuming data from PMS and at the same time, PMS is consuming data from
XEVMPD. Therefore, any product, that is required for eAF submission, such as herbal and/or
homeopathic medicinal products, must be submitted in the XEVMPD.

1
See also Traditional herbal medicinal products and simplified registrations for homeopathic medicinal products:
pharmacovigilance requirements and EudraVigilance access - Note for clarification for related information

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 12/200
eXtended EudraVigilance Medicinal Product Report Message (XEVPRM)
schema

Medicinal product data shall be submitted to the eXtended EudraVigilance Medicinal Product Dictionary
(XEVMPD) using the eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) schema.
For more information, please see the below listed documents for detailed information on the XEVPRM
structure and the applicable business rules:

• Chapter 2: Electronic submission of information on medicinal products by marketing authorisation

holders;

• Chapter 3.I: Extended EudraVigilance product report message (XEVPRM) technical specifications of
the published Detailed guidance on the electronic submission of information on medicinal products
for human use by marketing authorisation holders to the European Medicines Agency in accordance
with Article 57(2) of Regulation (EC) No. 726/2004;

• Extended EudraVigilance product report message (XEVPRM) schema.

XEVPRMs can be generated and submitted using an in-house gateway submission tool and/or using the
XEVMPD user interface (EVWEB).

XEVMPD user interface (EVWEB)

The XEVMPD user interface (EVWEB) is available to registered users. To access EVWEB, users are
required to have:

• set up a multi-factor authentication (MFA);

• requested access to the XEVMPD production environment via the EMA Account Management portal;
and

• installed ActiveX on their computer and access EVWEB using an IE Tab extension, as per
instructions on the ‘xEVMPD support’ section of the EV restricted area for EV Registered users.

Available operation types to be used in an XEVPRM

• Operation type 'Insert' (1): allows the sender organisation to insert medicinal product information
in the XEVMPD.

For EVWEB users, a command button 'Reinsert' (1) is also available. This operation type allows
EVWEB users to re-insert an existing medicinal product whilst retaining the previous information
and create a new medicinal product with the operation type 'Insert'.

• Operation type 'Update' (2): allows the sender organisation to correct erroneous information
previously submitted, as per applicable business and technical rules.

As per specific guidance provided in section 2. Maintenance of medicinal product data of this
document, this operation type shall be used to maintain some of the medicinal product
information.

• Operation type 'Variation' (3): This operation type is no longer available as it should not be used
to notify the Agency of a variation procedure of an authorised medicinal product in the context of
maintenance of medicinal product data during the transition maintenance phase. As of 16 June
2014, the "Variation" button is removed from the EVWEB application. Gateway users, who will
submit an XEVPRM containing an authorised medicinal product assigned with operation type

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 13/200
 'Variation' (3) will receive a negative XEVPRM acknowledgement as the entire XEVPRM will be
rejected.

The process to be followed to amend an authorised medicinal product entity following a variation
procedure is described in section 2.4.1. Variations of marketing authorisation of this document.

• Operation type 'Nullification' (4): allows users to flag incorrectly submitted information
(including duplicated information) as 'non-current', as per applicable business and technical rules.

• Operation type 'Change ownership' (5): This operation type is no longer available.

The relevant processes to be followed to amend an authorised medicinal product entity following a
transfer of marketing authorisation are described in section 2.4.3. Transfer of marketing
authorisation of this document.

• Operation type 'Invalidate MA' (6): This operation allows the sender organisation to submit a
notification about the withdrawal of an authorised medicinal product from the market in an
XEVPRM. The 'Invalidate MA' operation type covers several scenarios including the transfer of an
authorised medicinal product to a third party and a renewal of the marketing authorisation (MA) by
the marketing authorisation holder (MAH) if the marketing authorisation number changes.

Further information on specific scenarios where such operation can be used is provided in section
2. Maintenance of medicinal product data of this document.

XEVPRM Acknowledgements

Following a successful submission of new medicinal product data in the XEVMPD, an EV Code is
assigned to each XEVMPD entity (i.e., data element). The EV Code is provided to the marketing
authorisation holder sender organisation in an eXtended EudraVigilance Medicinal Product Report
Message Acknowledgement (XEVPRM ACK):

• users from MAH organisations registered as WEB Trader organisations, submitting XEVPRMs using
EVWEB or EV Post, can retrieve the XEVPRM ACK in their WEB Trader Inbox (or Archived Inbox),

• Gateway users should check with their Gateway provider where the XEVPRM ACKs are stored.

For more information related to XEVPRM Acknowledgements, please see also:

• Chapter 5: Extended EudraVigilance product report acknowledgement message and

• Chapter 3.I: Extended EudraVigilance product report message (XEVPRM) technical specifications of
the published Detailed guidance on the electronic submission of information on medicinal products
for human use by marketing authorisation holders to the European Medicines Agency in accordance
with Article 57(2) of Regulation (EC) No. 726/2004.

• List of XEVMPD Element Acknowledgement Codes, which can be found on the ‘Guidance documents
related to data submission for authorised medicines’ webpage.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 14/200
1. Initial submission of medicinal product data

1.1. Initial submission of an authorised medicinal product (AMP) entity

Authorised medicinal product (AMP) must be submitted in the XEVMPD in an XEVPRM with
operation type 'Insert' (1).

In accordance with point (b) of Article 57(2) of Regulation (EC) 726/2004: "marketing authorisation
holders shall, by 2 July 2012 at the latest, electronically submit to the European Medicines Agency (the
Agency) information on all medicinal products for human use authorised in the European Union, using
the format referred to in point (a)". This includes centrally authorised medicinal products.

In accordance with the Legal Notice on the Implementation of Article 57(2) of Regulation (EC) No.
726/2004, information on medicinal products for new marketing authorisations in the Union after 2
July 2012 shall be submitted by marketing authorisation holders electronically to the Agency as soon
as possible and no later than 15 calendar days from the date of authorisation (i.e., 15 calendar days
from the date of notification of the granting of the marketing authorisation by the competent
authority).

Regulatory processes for issuing marketing authorisations and authorisation numbers for medicinal
products can differ depending on the country of authorisation or the authorisation procedure. This has
been recognised as a challenge for the unique identification of medicinal products. The future use of
the ISO IDMP standards will allow for the assignment of additional identifiers as an indexing
mechanism, which can be applied supplementary to existing systems like the assignment of marketing
authorisation numbers.

Medicinal products are being characterised as part of the initial XEVPRM submissions based on the
main following characteristics:

a) Name of the medicinal product

b) Marketing authorisation holder

c) Marketing authorisation number

d) Authorising body (i.e., Competent Authority)

e) Qualitative and quantitative composition (ingredients, strength,

authorised/administrable pharmaceutical form)

Whenever any of the characteristics described above (point a. to e.) for a medicinal product are
different, a separate medicinal product entity should be submitted in the XEVMPD. This also applies to
medicinal products for which one marketing authorisation has been issued with the same marketing
authorisation number.

• For centrally authorised medicinal products, separate authorisation numbers (EU numbers)
exist for each medicinal product and package presentation. Therefore, for each presentation (each
EU number) a separate medicinal product entity should be submitted to the XEVMPD (see EXAMPLE
5).

• For non-centrally authorised medicinal products, one authorisation number can be applicable
either for each pack size or it can be the same for several pack sizes:

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 15/200
 − Whenever each pack size is authorised with a unique authorisation number, the same approach
as for centrally authorised products should be followed by marketing authorisation holders.
I.e., for each presentation (each authorisation number) a separate authorised medicinal
product entity should be submitted to the XEVMPD.

− When multiple pack sizes are authorised with one authorisation number, marketing
authorisation holders should submit in the XEVMPD multiple authorised medicinal product
entities, each referencing one package presentation and the applicable authorisation number.

As announced at the Product Management Service (PMS) info day in April 2024, the mandatory
provision of pack size information and the information on the product down to the pack size
level is now required due to the ISO IDMP standards implementation:

➔ To support the European Shortages Monitoring Platform (ESMP) requirements for

medicinal products under the Union List of Critical Medicines (ULCM), marketing
authorisation holders should ensure that, by 31 January 2025, one authorised medicinal
product entity exists in the XEVMPD for each pack size (see Option 2 of EXAMPLE 2).

MAHs that previously submitted in the XEVMPD one AMP record for multiple package
presentations should review their existing AMP entries and, where multiple pack sizes are
referenced in the 'Package Description' field:

1. update the existing AMP entity to reference only one pack size (the lowest one) and

2. to submit new AMP entities for the remaining pack sizes.

The list of critical medicines is published on the Availability of critical medicines webpage.

➔ For medicinal products not included under the ULCM, there is no defined deadline
to submit in the XEVMPD one medicinal product entity for each package presentation. It is
however recommended that information on newly authorised medicinal products is
submitted in the XEVMPD at the level of the pack size.

See Annex I: Pack size submissions of this document for further information.

The Presentation - Pack Size Submissions: from XEVMPD to PMS containing additional information,
questions and answers, and practical examples, is also available.

EXAMPLE 1

In Ireland, a marketing authorisation has been granted for 'Diclofenac 50 mg' formulation.
The marketing authorisation number is: PL 1234/000.
The marketing authorisation holder is company MAH-AZ.

The marketing authorisation refers to the following medicinal products names, i.e., the following
names listed in section 1 of the SmPC are:
'Diclofenac PharmaB 50 mg tablets'
'Diclofenac tablets'
'Diclofenac 50 mg'

Based on the principles outlined above (different medicinal product names), the marketing
authorisation holder should submit three separate medicinal product entries to the XEVMPD:

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 16/200
AMP entity 1: "Full Presentation Name" (AP.13.1) = Diclofenac PharmaB 50 mg tablets
AMP entity 2: "Full Presentation Name" (AP.13.1) = Diclofenac tablets
AMP entity 3: "Full Presentation Name" (AP.13.1) = Diclofenac 50 mg

EXAMPLE 2

In Ireland, marketing authorisation has been granted for the medicinal product 'Amoxicillin 200 mg
tablets'.

The medicinal product is available in the following pack sizes: 15 tablets, 30 tablets.

The marketing authorisation number applicable to both pack sizes is PL 1234/001.

The marketing authorisation holder is company MAH-XYZ.

Option 1

MAHs submits one authorised medicinal product entry in the XEVMPD, referencing multiple package
presentations in the 'Package Description' field:

AMP entity 1:
"Full Presentation Name" (AP.13.1) = Amoxicillin 200 mg tablets
"Authorisation Number" (AP.12.4) = PL 1234/001
"Package Description" (AP.13.7) = 15 tablets, 30 tablets

Option 2
MAHs submits two authorised medicinal product entries in the XEVMPD, each AMP entry referencing
the applicable package presentations in the 'Package Description' field:

AMP entity 1:
"Full Presentation Name" (AP.13.1) = Amoxicillin 200 mg tablets
"Authorisation Number" (AP.12.4) = PL 1234/001
"Package Description" (AP.13.7) = 15 tablets

AMP entity 2:
"Full Presentation Name" (AP.13.1) = Amoxicillin 200 mg tablets
"Authorisation Number" (AP.12.4) = PL 1234/001
"Package Description" (AP.13.7) = 30 tablets

EXAMPLE 3

In France, marketing authorisation has been granted for the medicinal product 'Paracétamol 150 mg
comprimés'.

The medicinal product is available in the following pack sizes: 30 tablets and 60 tablets.

The marketing authorisation number applicable: 123 456-7 (30 tablets), 123 456-8 (60 tablets).

The marketing authorisation holder is company MAH-XYZ.

Based on the principles outlined above (different authorisation number for each pack size), the
marketing authorisation holder should submit two medicinal product entries to the XEVMPD:

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 17/200
AMP entity 1:
"Full Presentation Name" (AP.13.1) = Paracétamol 150 mg comprimés
"Authorisation Number" (AP.12.4) = 123 456-7
"Package Description" (AP.13.7) = 30 comprimés

AMP entity 2:
"Full Presentation Name" (AP.13.1) = Paracétamol 150 mg comprimés
"Authorisation Number" (AP.12.4) = 123 456-8
"Package Description" (AP.13.7) = 60 comprimés

EXAMPLE 4

In the Ireland, marketing authorisation has been granted for the medicinal product 'Ibuprofen 250 mg'.

The medicinal product is available as film-coated tablets and capsules in separate package
presentations.

The marketing authorisation number applicable for both medicinal products: PL 1234/004.

The marketing authorisation holder is company MAH-XYZ.

Based on the principles outlined above (different pharmaceutical forms), the marketing authorisation
holder should submit two medicinal product entries to the XEVMPD:

AMP entity 1 (film-coated tablet):

"Full Presentation Name" (AP.13.1) = Ibuprofen 250 mg
"Authorisation Number" (AP.12.4) = PL 1234/004
"Pharmaceutical form" = Film-coated tablet

AMP entity 2 (capsule):

"Full Presentation Name" (AP.13.1) = Ibuprofen 250 mg
"Authorisation Number" (AP.12.4) = PL 1234/004
Pharmaceutical form = Capsule

EXAMPLE 5

In the EU, marketing authorisation has been granted for the medicinal product 'COMET'.

The medicinal product is available as 10 mg and 40 mg tablets in the same package presentation.

The marketing authorisation number is EU/1/13/999/001.

The marketing authorisation holder is company MAH-ABC.

Section 1. Name of the medicinal product states of the SmPC states:

COMET 10 mg tablets
COMET 40 mg tablets

The marketing authorisation holder should submit one medicinal product entity with the two
pharmaceutical products (i.e., 10 mg tablets and 40 mg tablets) to the XEVMPD:

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 18/200
"Full Presentation Name" (AP.13.1) = COMET 10 mg + 40 mg film-coated tablets
"Authorisation Number" (AP.12.4) = EU/1/13/999/001
"EU Number" (AP.12.8) = EU/1/13/999/001
"Package Description" (AP.13.7) = Blister (PVC-Alu) – 14 x 10 mg + 14 x 40 mg tablets

EXAMPLE 6

Marketing authorisation has been granted for a centrally authorised medicinal product 'TRADENAME
XYZ 50 U/ml and 100 U/ml Concentrate for solution for infusion'.

The marketing authorisation holder is company MAH-LMN.

The marketing authorisation numbers, and the corresponding package descriptions are:

EU/1/03/000/001: TRADENAME XYZ - 100 U/ml - Concentrate for solution for infusion - Intravenous
use - vial (glass) - 5 ml (100 U/ml) – 1 vial

EU/1/03/000/002: TRADENAME XYZ - 100 U/ml - Concentrate for solution for infusion - Intravenous
use - vial (glass) - 5 ml (100 U/ml) - 10 vials

EU/1/03/000/003: TRADENAME XYZ - 50 U/ml - Concentrate for solution for infusion - Intravenous
use - vial (glass) - 5 ml (50 U/ml) - 1 vial

EU/1/03/000/004: TRADENAME XYZ - 50 U/ml - Concentrate for solution for infusion - Intravenous use
- vial (glass) - 5 ml (50 U/ml) – 10 vials

Based on the principles outlined above (different authorisation numbers for each presentation) the
marketing authorisation holder should submit four medicinal product entries to the XEVMPD:

AMP entity 1:
"Full Presentation Name" (AP.13.1) = TRADENAME XYZ 100 U/ml Concentrate for solution for
infusion
"Authorisation Number" (AP.12.4) = EU/1/03/000/001
"EU Number" (AP.12.8) = EU/1/03/000/001
"Package Description" (AP.13.7) = 1 vial

AMP entity 2:
'Full Presentation Name' field = TRADENAME XYZ 100 U/ml Concentrate for solution for
infusion
"Authorisation Number" (AP.12.4) = EU/1/03/000/002
"EU Number" (AP.12.8) = EU/1/03/000/002
"Package Description" (AP.13.7) = 10 vial

AMP entity 3:
"Full Presentation Name" (AP.13.1) = TRADENAME XYZ 50 U/ml Concentrate for solution for
infusion
"Authorisation Number" (AP.12.4) = EU/1/03/000/003
"EU Number" (AP.12.8) = EU/1/03/000/003
"Package Description" (AP.13.7) = 1 vial

AMP entity 4:

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for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 19/200
"Full Presentation Name" (AP.13.1) = TRADENAME XYZ 50 U/ml Concentrate for solution for
infusion
"Authorisation Number" (AP.12.4) = EU/1/03/000/004
"EU Number" (AP.12.8) = EU/1/03/000/004
"Package Description" (AP.13.7) = 10 vial

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for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 20/200
Table 1a- Authorised medicinal product – language requirements

Medicinal Country of Medicinal Substance Attachment: Summary of

Product authorisation Product Data Name* Product Characteristics
Authorisation (AP.12.1) Elements (PP.ACT.1, (SmPC)
Procedure (AP.13.1- PP.ADJ.1,
(AP.PPI.1)
(AP.12.2) AP.13.6) PP.EXC.1)

Centralised EU Member English All official EU English

Procedure states languages (Other languages available at
(CAP) the Agency)
Iceland, English National English + National language(s)
Liechtenstein language(s) of of the country of authorisation
and Norway the country of where available
(IS/LI/NO) authorisation

Mutual EU Member National National National language(s) of the

Recognition state, language(s) of language(s) of country of authorisation
Procedure (IS/LI/NO) the country of the country of (Common approved English text
(MRP) authorisation authorisation acceptable only if national
SmPCs are not available)**
Decentralised EU Member National National National language(s) of the
Procedure state, language(s) of language(s) of country of authorisation
(DCP) (IS/LI/NO) the country of the country of (Common approved English text
authorisation authorisation acceptable only if national
SmPCs are not available)**
National EU Member National National National language(s) of the
Procedure state, language(s) of language(s) of country of authorisation
(NAP) (IS/LI/NO) the country of the country of
authorisation authorisation

* Plant Latin binominal names or Latin herbal preparation names of authorised medicinal products if
reflected in the SmPC are also acceptable.

** When the SmPC in the national language becomes available, it must be provided in the context of
the data maintenance, i.e., when the variation leads to changes as listed in section Transition
maintenance phase - Electronic submission plan

List of official languages per country can be found on the Agency's website.

If the same SmPC contains product information in multiple languages, the same SmPC may be
referenced in the relevant product entries. It is possible to reference two language codes in one
attachment entity in the XEVMPD. See section 1.10.7. 2nd Language code (ATT.7) for further
information.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
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1.1.1. Submission of information for medicinal products authorised in EEA
countries outside the EU

In general, Iceland, Liechtenstein, and Norway, have, through the EEA agreement, adopted the
complete Union acquis on medicinal products and are consequently applying the EU rules governing
marketing authorisation procedures (i.e., national, centralised, decentralised, and mutual recognition
procedures). However, the Commission’s decisions (including decisions granting marketing
authorisations) do not directly confer rights and obligations to holders of a marketing authorisation in
these countries. The marketing authorisations granted by the European Commission must be
transposed by the competent authorities of Iceland, Liechtenstein, and Norway through corresponding
decisions on the basis of relevant national laws. In such a case these marketing authorisations granted
in Iceland, Liechtenstein and Norway are legally separate from the Commission’s decision granting MA.

Therefore, separate entries for the marketing authorisations granted in Iceland, Liechtenstein and
Norway should be submitted in the XEVMPD under Article 57(2) requirements.

For medicinal products authorised in Liechtenstein, Norway and Iceland under the centralised
procedure, the applicable country code (i.e., LI/NO/IS) must be specified.

1.1.1.1. Submission of information for medicinal products authorised in Liechtenstein

It is clarified in the Notice to Applicants (Volume 2A, Chapter 1) that on the basis of a bilateral
agreement between Liechtenstein and Austria automatic recognition of the Marketing Authorisations
granted in Mutual Recognition Procedure (MRP) or Decentralised Procedure (DCP) is operational. This
allows Liechtenstein to use Marketing Authorisations granted by Austria if the applicants have identified
Liechtenstein as CMS in the application form submitted with MRP or DCP applications. At the end of the
procedures, Austria grants authorisations that are recognised by Liechtenstein. This marketing
authorisation can be considered as a marketing authorisation granted in accordance with the
pharmaceutical acquis for the purpose of EU legislation.
Therefore, the marketing authorisation of these products has to fulfil requirements provided for in,
inter alia, Regulation (EU) 726/2004 and Directive 2001/83/EC.

• The attachment to be used for reference in a medicinal product entity is an Austrian SmPC.
• The data elements AP.13.1 - AP.13.6 must however be provided in German.

In the Notice to Applicants (Volume 2A, Chapter 1) it is also clarified that on the basis of a bilateral
agreement between Liechtenstein and Switzerland, a Swiss marketing authorisation is effective in
Liechtenstein. This recognition has no effects outside the customs union between Switzerland and
Liechtenstein. Consequently, a marketing authorisation granted by the Swiss authorities and
recognised by Liechtenstein, while Switzerland does not apply the EU pharmaceutical acquis, cannot be
considered as a marketing authorisation granted in accordance with the pharmaceutical acquis for the
purpose of EU legislation and therefore falls outside the scope of, inter alia, Regulation (EU) 726/2004
and Directive 2001/83/EC.

Therefore, marketing authorisations granted by the Swiss authorities and recognised by Liechtenstein
fall out of scope of Article 57(2) requirements and do not therefore need to be submitted to the
XEVMPD per Article 57(2) requirements.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 22/200
1.1.2. Submission of information for medicinal products authorised outside
the EU/EEA

The submission of information on medicinal products authorised outside the EEA in the Article 57
database is out of scope of Article 57 (2) legal requirements.

Information about such medicinal products can be submitted in the Article 57 database on voluntary
basis:

• The authorisation country code (AP.12.1) must not be specified as "EU" or any of the EEA
countries.

• Non EU authorisation procedure (5) must be referenced in the AMP entries.

Table 1b - Requirements for AMP records and attachments for countries

with more than one national language

Country National AMP Attachment Comment Language

language(s) record to be used to be used
required? for to enter
reference data
elements in
fields
AP.13.1 -
AP.13.6

Belgium Dutch Yes SmPC Dutch

French Yes SmPC French
German Yes PIL Since there is no German
SmPC in German, the
PIL is to be used.
The document
granting
authorisation/renewal
should also be
provided if the
authorisation number
is not stated in the
referenced PIL.
Finland Finnish Yes SmPC Finnish
Swedish Yes SmPC The document Swedish
granting
authorisation/renewal
should also be
provided if the
authorisation number
is not stated in the
referenced document.
Ireland English Yes SmPC English

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Country National AMP Attachment Comment Language
language(s) record to be used to be used
required? for to enter
reference data
elements in
fields
AP.13.1 -
AP.13.6

Irish No n/a Authorisations are not n/a

issued in Irish and no
SmPC/PIL exists in
this language.
Luxembourg* French Yes SmPC or an French or Belgian French
equivalent SmPC/PIL in French
document can be used.
(e.g., PIL or The document
similar text granting
as authorisation/renewal
authorised should also be
by the provided if the
Authorising authorisation number
Body) is not stated in the
referenced SmPC/PIL.
German Yes SmPC or an German, Austrian or German
equivalent Belgian SmPC/PIL in
document German can be used.
(e.g., PIL or The document
similar text granting
as authorisation/renewal
authorised should also be
by the provided if the
Authorising authorisation number
Body) is not stated in the
referenced SmPC/PIL.
Luxemburgish No n/a Authorisations are not n/a
issued in
Luxemburgish and no
SmPC/PIL exists in
this language.
Malta English Yes SmPC The document English
granting
authorisation/renewal
should also be
provided if the
authorisation number
is not stated in the
referenced SmPC.
Maltese No Authorisations are not n/a

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Country National AMP Attachment Comment Language
language(s) record to be used to be used
required? for to enter
reference data
elements in
fields
AP.13.1 -
AP.13.6

issued in Maltese and

no SmPC/PIL exists in
this language.
* Table 1b covers the scenario when the French as well as the German SmPC/PIL are provided to the
Luxembourgish Authority. If the MAH decided to provide only the French SmPC/PIL, or only the
German SmPC/PIL to the Luxembourgish Authority, then only one product entity referencing the
applicable document should be submitted in the XEVMPD.

Where, in exceptional circumstances, the national SmPC for non-centrally authorised products
(MRPs/DCPs/NAPs) is not available a similar text (i.e., the English common text, package information
leaflet or other similar text as authorised by the authorising body) can be used as an attachment for
the submission in the XEVMPD. The data elements AP.13.1 - AP.13.6 must however be provided in the
language of the country where the marketing authorisation applies.

Table 2 - Art 57(2) data element requirements overview for authorised

medicinal product submission

Reference Schema Field Name EVWEB Rules for Art Guidance Link
Code Field Label 57(2)
submission:

M - Mandatory

M*-
Mandatory

with
conditions

O – Optional

Authorised Product M
elements
M.AP Authorisedproduct
@ AP..1 (@)operationtype Operation M Available operation
Type types to be used in an
XEVPRM
AP.1 localnumber M* 1.2.1.
AP.2 ev_code EV Code M* 1.2.2.

Detailed guidance on the electronic submission of information on medicinal products

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EMA/135580/2012 Page 25/200
AP.3 newownerid New Owner EMA Use Only 1.2.3.
ID
AP.4 mahcode MAH M 1.2.4.
@ AP.4..1 (@)resolutionmode M
AP.5 qppvcode QPPV M 1.2.5.
Master File M* 1.2.6.
AP.6 mflcode
Location
M* See Chapter 3.I of the
Detailed guidance:
Extended
@ AP.6..1 (@)resolutionmode EudraVigilance
product report
message (XEVPRM)
technical specifications
AP.7 enquiryemail PhV Enquiry M 1.2.7.
Email
AP.8 enquiryphone PhV Enquiry M 1.2.8.
Phone
AP.9 senderlocalcode Sender Local O 1.2.9.
Code
AP.10 infodateformat O 1.2.10.
AP.11 infodate Info Date M* 1.2.11.
AP.14 comments Comment M* 1.2.16.
Authorised Product – M
Authorisation element
AP.12 authorisation
AP.12.1 authorisationcountrycode Authorisatio M 1.2.12.1.
n Country
Code
AP.12.2 authorisationprocedure Authorisatio M 1.2.12.2.
n Procedure
AP.12.3 authorisationstatus Authorisatio M 1.2.12.3.
n Status
AP.12.4 authorisationnumber Authorisatio M 1.2.12.4.
n Number
AP.12.5 authorisationdate Authorisatio M 1.2.12.5.
n/Renewal
Date EV Web field label
changed from
"Authorisation Date"
to
"Authorisation/Renewa
l Date"
AP.12.6 authorisationdateformat M 1.2.12.6.

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EMA/135580/2012 Page 26/200
AP.12.7 mrpnumber MRP/DCP/EM M* 1.2.12.7.
EA Number
EV Web field label
changed from
"MRP/DCP Number" to
"MRP/DCP/EMEA
Number"
AP.12.8 eunumber EU Number M* 1.2.12.8.
AP.12.13 legalbasis Legal Basis M 1.2.12.13.
AP.12.9 orphandrug Orphan Drug M 1.2.12.9.
AP.12.10 Intensivemonitoring Additional O 1.2.12.10.
Monitoring
EV Web field label
changed from
"Intensive Monitoring"
to "Additional
Monitoring"
AP.12.11 withdrawndateformat M* 1.2.12.11.
AP.12.12 withdrawndate Invalidated M* 1.2.12.12.
Date
Elements within the M New element
Medicinal Product Types applicable from June
element 2014
AP.XX
medicinalproducttype
AP.12.MPTs medicinalproducttype Medicinal M* 1.2.12.14.
Product
Types
Elements within the
Authorised Product –
Presentation Name M
element
AP.13 presentationname
AP.13.1 productname Full M 1.2.13.1.
Presentation
Name
AP.13.2 productshortname Product M* 1.2.13.2.
Short Name
AP.13.3 productgenericname Product M* 1.2.13.3.
INN/Commo
n Name EV Web Field label
changed from
"Product Generic
Name" to "Product
INN/Common Name"

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EMA/135580/2012 Page 27/200
AP.13.4 productcompanyname Product M* 1.2.13.4.
Company
Name
AP.13.5 productstrength Product M* 1.2.13.5.
Strength
Name
AP.13.6 productform Product M* 1.2.13.6.
Form Name
AP.13.7 packagedesc Package O 1.2.15.
Description
Elements within the M
Authorised
Pharmaceutical Forms
element
AP.XX
authpharmforms
AP.APF authpharmform M 1.2.14.

The Pharmaceutical M
Product – Active
Ingredient element
PP.ACT activeingredient
PP.ACT.1 substancecode Substance M 1.2.17.4.
Name
@ (@)resolutionmode M See Chapter 3.I of the
PP.ACT.1..1 Detailed guidance:
Extended
EudraVigilance
product report
message (XEVPRM)
technical specifications
PP.ACT.2 concentrationtypecode Amount M 1.2.17.6.
Value Type
PP.ACT.3 lowamountnumervalue Low Amount M (Low Amount)
Numerator Numerator Value
Value (PP.ACT.3)
PP.ACT.4 lowamountnumerprefix Low Amount M (Low Amount)
Numerator Numerator Prefix
prefix (PP.ACT.4)
PP.ACT.5 lowamountnumerunit Low Amount M (Low Amount)
Numerator Numerator Unit
Unit (PP.ACT.5)
PP.ACT.6 lowamountdenomvalue Low Amount M (Low Amount)
Denominator Denominator Value
Value (PP.ACT.6)
PP.ACT.7 lowamountdenomprefix Low Amount M (Low Amount)
Denominator Denominator Prefix
prefix (PP.ACT.7)

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PP.ACT.8 lowamountdenomunit Low Amount M (Low Amount)
Denominator Denominator Unit
Unit (PP.ACT.8)
PP.ACT.9 highamountnumervalue High Amount M* High Amount
Numerator Numerator Value
Value (PP.ACT.9)
PP.ACT.10 highamountnumerprefix High Amount M* High Amount
Numerator Numerator Prefix
prefix (PP.ACT.10)
PP.ACT.11 highamountnumerunit High Amount M* High Amount
Numerator Numerator Unit
Unit (PP.ACT.11)
PP.ACT.12 highamountdenomvalue High Amount M* High Amount
Denominator Denominator Value
Value (PP.ACT.12)
PP.ACT.13 highamountdenomprefix High Amount M* High Amount
Denominator Denominator Prefix
prefix (PP.ACT.13)
PP.ACT.14 highamountdenomunit High Amount M* High Amount
Denominator Denominator Unit
Unit (PP.ACT.14)
M*
The Pharmaceutical
Product – Adjuvant
elements
PP.ADJ adjuvant
PP.ADJ.1 substancecode Substance M 1.2.17.10.
Name
@ (@)resolutionmode M See Chapter 3.I of the
PP.ADJ.1..1 Detailed guidance:
Extended
EudraVigilance
product report
message (XEVPRM)
technical specifications
PP.ADJ.2 concentrationtypecode Amount M Same principle as
Value Type described in 1.2.17.6.
PP.ADJ.3 lowamountnumervalue Low Amount M Same principle as
Numerator described in (Low
Value Amount)
Numerator Value
(PP.ACT.3)
PP.ADJ.4 lowamountnumerprefix Low Amount M Same principle as
Numerator described in (Low
prefix Amount) Numerator
Prefix (PP.ACT.4)

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PP.ADJ.5 lowamountnumerunit Low Amount M Same principle as
Numerator described in (Low
Unit Amount) Numerator
Unit (PP.ACT.5)
PP.ADJ.6 lowamountdenomvalue Low Amount M Same principle as
Denominator described in (Low
Value Amount) Denominator
Value (PP.ACT.6)
PP.ADJ.7 lowamountdenomprefix Low Amount M Same principle as
Denominator described in (Low
prefix Amount) Denominator
Prefix (PP.ACT.7)
PP.ADJ.8 lowamountdenomunit Low Amount M Same principle as
Denominator described in (Low
Unit Amount) Denominator
Unit (PP.ACT.8)
PP.ADJ.9 highamountnumervalue High Amount M* Same principle as
Numerator described in High
Value Amount Numerator
Value (PP.ACT.9)
PP.ADJ.10 highamountnumerprefix High Amount M* Same principle as
Numerator described in High
prefix Amount Numerator
Prefix (PP.ACT.10)
PP.ACT.11 highamountnumerunit High Amount M* Same principle as
Numerator described in High
Unit Amount Numerator
Unit (PP.ACT.11)
PP.ADJ.12 highamountdenomvalue High Amount M* Same principle as
Denominator described in High
Value Amount Denominator
Value (PP.ACT.12)
PP.ADJ.13 highamountdenomprefix High Amount M* Same principle as
Denominator described in High
prefix Amount Denominator
Prefix (PP.ACT.13)
PP.ADJ.14 highamountdenomunit High Amount M* Same principle as
Denominator described in High
Unit Amount Denominator
Unit (PP.ACT.14)
The Pharmaceutical M*
Product – Excipient
element
PP.EXC excipient
PP.EXC.1 substancecode Substance M 1.2.17.8.
Name

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@ (@)resolutionmode M See Chapter 3.I of the
PP.EXC.1..1 Detailed guidance:
Extended
EudraVigilance
product report
message (XEVPRM)
technical specifications
PP.EXC.2 concentrationtypecode Amount O Same principle as
Value Type described in 1.2.17.6.
PP.EXC.3 lowamountnumervalue Low Amount O Same principle as
Numerator described in (Low
Value Amount) Numerator
Value (PP.ACT.3)
PP.EXC.4 lowamountnumerprefix Low Amount O Same principle as
Numerator described in (Low
prefix Amount) Numerator
Prefix (PP.ACT.4)
PP.EXC.5 lowamountnumerunit Low Amount O Same principle as
Numerator described in (Low
Unit Amount) Numerator
Unit (PP.ACT.5)
PP.EXC.6 lowamountdenomvalue Low Amount O Same principle as
Denominator described in (Low
Value Amount) Denominator
Value (PP.ACT.6)
PP.EXC.7 lowamountdenomprefix Low Amount O Same principle as
Denominator described in (Low
prefix Amount) Denominator
Prefix (PP.ACT.7)
PP.EXC.8 lowamountdenomunit Low Amount O Same principle as
Denominator described in (Low
Unit Amount) Denominator
Unit (PP.ACT.8)
PP.EXC.9 highamountnumervalue High Amount O Same principle as
Numerator described in High
Value Amount Numerator
Value (PP.ACT.9)
PP.EXC.10 highamountnumerprefix High Amount O Same principle as
Numerator described in High
prefix Amount Numerator
Prefix (PP.ACT.10)
PP.EXC.11 highamountnumerunit High Amount O Same principle as
Numerator described in High
Unit Amount Numerator
Unit (PP.ACT.11)

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PP.EXC.12 highamountdenomvalue High Amount O Same principle as
Denominator described in High
Value Amount Denominator
Value (PP.ACT.12)
PP.EXC.13 highamountdenomprefix High Amount O Same principle as
Denominator described in High
prefix Amount Denominator
Prefix (PP.ACT.13)
PP.EXC.14 highamountdenomunit High Amount O Same principle as
Denominator described in High
Unit Amount Denominator
Unit (PP.ACT.14)
M
The Pharmaceutical
Product element
PP
pharmaceuticalproduct
PP.1 pharmformcode Administrabl M 1.2.17.1.
e
Pharmaceuti EV Web Field label
cal Form changed from
"Pharmaceutical Form"
to "Administrable
Pharmaceutical Form"
@PP.1..1 (@)resolutionmode M See Chapter 3.I of the
Detailed guidance:
Extended
EudraVigilance
product report
message (XEVPRM)
technical specifications
M
Elements within the
Authorised Product –
Product Indication
element
AP.IND
productindication
AP.IND.1 meddraversion MedDRA M 1.2.19.1.
Version
AP.IND.2 meddralevel MedDRA M 1.2.19.2.
Level
AP.IND.3 meddracode MedDRA M 1.2.19.3.
Term

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 M
The Pharmaceutical
Product – Administration
Route element
PP.AR adminroute
PP.AR.1 adminroutecode Route Of M 1.2.17.2.
Administrati
on
@ PP.AR.1..1 (@)resolutionmode M See Chapter 3.I of the
Detailed guidance:
Extended
EudraVigilance
product report
message (XEVPRM)
technical specifications
M
Elements within the
Authorised Product –
ATC element
AP.ATC productatc
AP.ATC.1 atccode ATC Code M 1.2.18.
@ (@)resolutionmode M See Chapter 3.I of the
AP.ATC.1..1 Detailed guidance:
Extended
EudraVigilance
product report
message (XEVPRM)
technical specifications
M*
The Pharmaceutical
Product – Medical Device
elements
PP.MD.1 medicaldevicecode Medical M 1.2.17.12.
Device
M
The Authorised Product
– Printed Product
Information Attachment
element
AP.PPI ppiattachment
AP.PPI.1 attachmentcode Product M 1.2.21.1.
Attachment

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@ (@)resolutionmode M See Chapter 3.I of the
AP.PPI.1..1 Detailed guidance:
Extended
EudraVigilance
product report
message (XEVPRM)
technical specifications
AP.PPI.2 validitydeclaration Validity M* 1.2.21.2.
Declaration

1.2. Authorised medicinal product - element structure

The below schema shows the individual data fields/sections to be provided for an authorised medicinal
product submission.

The XEVPRM field description may differ from EVWEB field description and so each field name also
references the assigned XEVPRM field code (e.g., AP.13.4, AP.PPI.1). For example:

Field AP.13.1
XEVPRM field description = "productname"
EVWEB field description = "Full Presentation Name"

Field AP.13.3
XEVPRM field description = "productgenericname"
EVWEB field description = "Product INN/Common Name"

In 16 June 2014, the XEVPRM schema was amended to allow for submission of additional information:

Detailed guidance on the electronic submission of information on medicinal products

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1.2.1. Local Number (AP.1)

A unique reference number for an AMP entity in an XEVPRM after an operation type 'Insert'
(1) was applied must be assigned.

When an authorised medicinal product is submitted in an XEVPRM with the operation 'Insert' (1) a local
number must be assigned to this product. When the XEVPRM Acknowledgement is received, and
providing that the submission was successful, this local number should be used to identify the
corresponding EV Code.

EXAMPLE: XEVPRM - Insert of an AMP

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EXAMPLE - XEVPRM Acknowledgement received following an insert of an AMP

See also document Quality Control of medicinal product data submitted as per the legal requirement
introduced by Article 57(2) of Regulation (EC) No 726/2004 for related information.

1.2.2. EV Code (AP.2)

The EudraVigilance (EV) Code of the authorised medicinal product must be specified if the
operation type is NOT an 'Insert' (1).

I.e., if a maintenance related operations are performed on an authorised medicinal product entity
which was successfully inserted in the XEVMPD, the EV Code of the AMP entity must be referenced in
this data field.

1.2.3. New Owner ID (AP.3)

This field is reserved for EMA use only.

1.2.4. Marketing authorisation holder (MAH) code (AP.4)

Marketing authorisation holder code corresponding to the legal entity of the medicinal
product in a given country as indicated in section 7. Marketing Authorisation Holder of the
SmPC must be specified.

• If the MAH organisation was previously successfully submitted in the XEVMPD, and an MAH
organisation EV Code had been assigned, the MAH can be selected from the available remote
look-up table (EVWEB users).

Gateway users should populate the 'MAH code' field (AP.4) with the assigned organisation EV Code
received in the XEVPRM Acknowledgement.

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• If the MAH organisation is not present in the XEVMPD and it is being submitted together with the
product information via the same XEVPRM, the MAH can be selected from the available local look-
up table (EVWEB users). See section 1.6. Initial submission of a marketing authorisation holder
(MAH) organisation of this document for further information on how to submit an MAH organisation
in the XEVMPD.

NOTE 1

The most up-to-date list of available MAH organisations with their assigned EV Codes, can be found in
the MAH remote look-up table in the XEVMPD Data Entry Tool (EVWEB).

The 'MAH' remote look-up table in EVWEB contains details of the marketing authorisation holder
organisations available in the XEVMPD, as they were submitted by MAH users. The table does not
contain:

• the list of organisations registered with EudraVigilance nor

• the list of all organisations available in the Organisations Management System (OMS).

The list of organisations registered with EudraVigilance is a list of all registered stakeholders
(regulators, pharmaceutical industry, and sponsors) and is accessible to registered users in the
restricted area of the EudraVigilance Human website.

The list of organisations available in OMS can be exported from OMS. Integration between
EudraVigilance and OMS is completed and therefore all organisation EV Codes are available in the
'Mappings' sections of MAH records in OMS.

Until February 2023, the EMA used to publish the list of MAH organisations, with the assigned EV
Codes, available in the XEVMPD. The published MAH CV list is no longer updated; MAHs should check
the required organisation details in EVWEB or in OMS.

1.2.5. Qualified Person responsible for Pharmacovigilance (QPPV) code

(AP.5)

The QPPV code of the QPPV responsible for the authorised medicinal product must be
specified.

The QPPV code is assigned by the Agency’s EudraVigilance user & and organisation management
system and can be retrieved from:

• the EudraVigilance website (restricted area accessible for registered users only) under 'QPPV list'
(by Gateway/EVWEB users):

Detailed guidance on the electronic submission of information on medicinal products

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• and/or in the EudraVigilance look-up table in EVWEB (by EVWEB users):

If the required QPPV does not exist in the XEVMPD, please refer to section 1.3. Initial submission of a
QPPV information of this document for information on how to submit QPPV information in the XEVMPD.

MAHs must ensure that the QPPV Code referenced in their AMPs is a valid QPPV Code referring to a
current QPPV (e.g., the QPPV Code is not "retired").

1.2.6. Pharmacovigilance System Master File Location (PSMFL) code (AP.6)

The Pharmacovigilance System Master File Location (PSMFL) EV Code of the place, where
the PSMF for the authorised medicinal product is located, must be specified, if the PSMFL
information was submitted in the XEVMPD and the PSMFL Code is available.

From 2 July 2015 MAHs are required to submit the Pharmacovigilance System Master File information
to the Article 57 database (aka XEVMPD). The PSMFL EV Code therefore must be referenced in the AMP
entity.

MFL EV Code is a unique code assigned by the XEVMPD to a specific PSMF and PSMF location.

• If the PSMFL information was previously successfully submitted in the XEVMPD, and a PSMFL EV
Code had been assigned, the PSMFL can be selected from the available remote look-up table
(EVWEB users).

Gateway users should populate the 'MFL' field (AP.6) with the assigned MFL EV Code received in
the XEVPRM Acknowledgement.

• If the PSMFL information is not present in the XEVMPD and it is being submitted together with the
product information via the same XEVPRM, the PSMFL can be selected from the available local
look-up table (EVWEB users). See section 1.11. Initial submission of a Pharmacovigilance System
Master File (PSMF) information of this document for further information.

Information on how the PSMFL entity should be maintained is described in section 2.3.
Maintenance of a Pharmacovigilance System Master File Location (PSMFL) entity.

1.2.7. Pharmacovigilance enquiry email (AP.7)

The email address, where enquiries related to Pharmacovigilance can be submitted, must be
specified.

Detailed guidance on the electronic submission of information on medicinal products

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The marketing authorisation holder needs to decide, which email address they wish to specify for
dealing with Pharmacovigilance enquiries. The contact information for Pharmacovigilance enquires (e-
mail and phone) is made public by the Agency.

No trailing spaces should be entered after the email address in the XEVPRM submission as this will lead
to the XEVPRM being rejected by the system; in such case, the message "Missing Mandatory
Information - Enquiry mail is not a valid email address" will be included in the XEVPRM
Acknowledgement.

1.2.8. Pharmacovigilance enquiry phone (AP.8)

The phone number, where enquiries related to Pharmacovigilance can be directed, must be
specified.

The marketing authorisation holder needs to decide, which phone number they wish to specify for
dealing with Pharmacovigilance enquiries. It may be the same as the phone number of the QPPV.
The contact information for Pharmacovigilance enquires (e-mail and phone) is made public by the
Agency.

1.2.9. Sender local code (AP.9)

The sender local code for the authorised medicinal product used by the marketing
authorisation holder for internal reference purposes may be specified.

The sender local code specified by the MAH is not used in the XEVMPD for maintenance. It can be any
technical code.

1.2.10. Info date format (AP.10)

Format of the info date should correspond to "102" for "CCYYMMDD".

1.2.11. Info date (AP.11)

The date, when the lifting of suspension of the marketing authorisation becomes effective,
must be specified when "Authorisation Status" changes from "Valid - Suspended" to any
"Valid" status.

It is not technically possible to specify a future date in this data element (i.e., the date must either be
the same as the date of submission or precede the date of submission of your XEVPRM).

"Info date" field (AP.11) is linked to the "Authorisation status" information.

When the "Authorisation status" (AP.12.3) changes from "Valid – Suspended (2)" to:

• Valid (1); or

• Valid – Renewed/Varied Marketing Authorisation (8); or

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• Valid - Transferred Marketing Authorisation (9);

the data element in "Info date" field (AP.11) should indicate the date when the lifting of the suspension
of the marketing authorisation becomes effective.

1.2.12. AMP - Authorisation details element structure (AP.12)

1.2.12.1. Authorisation country code (AP.12.1)

The country code of the country of authorisation must be specified.

The country code is to be specified using the ISO-3166-1 standard. The official list of ISO 3166-1
country codes is maintained by the International Organization for Standardization (ISO).

• For medicinal products authorised under the centralised procedure, "European Union (EU)"
should be specified.

− Until the date on which Regulation (EU) 2023/1182 becomes applicable, 'EU' includes the
territory of Northern Ireland. Therefore, to indicate that a marketing authorisation of a

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
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 medicinal product approved via the centralised procedure is valid in the territory of Northern
Ireland, 'EU' should be referenced as the country of authorisation.

After the date on which Regulation (EU) 2023/1182 become applicable, referencing 'EU' as the
country of authorisation will automatically no longer include the territory of Northern Ireland.

− For medicinal products authorised through the centralised procedure in Liechtenstein, Norway,
and Iceland, the applicable country code (i.e., LI/NO/IS) must be specified.

• For medicinal products authorised under a national procedure (NAP), the mutual recognition
procedure (MRP) and/or the decentralised (DCP) procedure, the applicable EEA country
should be specified. See also NOTE 2 for related information.

• For medicinal products authorised in a non-EU authorisation procedure, a non-EEA country

should be specified. Medicinal products authorised through a non-EU procedure are submitted in
the XEVMPD on voluntary basis. Such products are not within the scope of Article 57(2)
requirements.

NOTE 2

• For United Kingdom, the code "GB" should be used as the officially assigned code in accordance
with the ISO country codes in case of voluntary submission of information on medicinal products
with marketing authorisation valid in England, Wales and Scotland.

"UK" is a "reserved code" assigned at the request of the national ISO member bodies,
governments, and international organizations. This applies to certain code elements required to
support a particular application as specified by the requesting body and limited to such use. Any
further use of such code elements is subject to approval by the ISO 3166/MA. More information
about the reserved codes can be found on the ISO website.

• For Greece, the code "GR" (not "EL") should be used as the officially assigned code in accordance
with the ISO country codes.

• For "United Kingdom (Northern Ireland)" the assigned country code ''XI'' should be used in
submissions of information on medicinal products with marketing authorisation valid in the territory
of Northern Ireland.

1.2.12.2. Authorisation procedure (AP.12.2)

The procedure, through which the medicinal product was authorised, must be specified.

List of available authorisation procedure values can be found in the 'eXtended Eudravigilance Product
Dictionary (XEVMPD) authorisation procedures' list published on the ‘Guidance documents related to
data submission for authorised medicines’ webpage.

• EU authorisation procedures - Centralised Procedure (1): must be selected when entering

information for a centrally authorised medicinal product.

− The authorisation country code (AP.12.1) must be specified as "EU".

− For medicinal products authorised in Liechtenstein, Norway, and Iceland through the
centralised procedure the applicable country code (i.e., LI/NO/IS) must be specified.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
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EMA/135580/2012 Page 41/200
 See the Commission's website for information on the centralised procedure.

• EU authorisation procedures - Mutual Recognition Procedure (3): must be selected when

entering mutually recognised medicinal product and in case of a repeat-use procedure.

− The authorisation country code (AP.12.1) must be specified as one of the EEA countries and/or
as "XI". See NOTE 2 for information related to some specific country codes.

See the Commission's website for information on the mutual recognition procedure.

• EU authorisation procedures - National Procedure (4): must be selected when entering

nationally authorised medicinal products.

− The authorisation country code (AP.12.1) must be specified as one of the EEA countries and/or
as "XI". See NOTE 2 for information related to some specific country codes.

• Non EU authorisation procedure (5): must be selected when entering medicinal products
authorised outside the EEA.

− The authorisation country code (AP.12.1) must not be specified as "EU" or any of the EEA
countries and/or "XI". See NOTE 2 for information related to some specific country codes.

• EU authorisation procedures - Decentralised Procedure (7): must be selected when entering

medicinal product authorised in decentralised procedure.

− The authorisation country code (AP.12.1) must be specified as one of the EEA countries and/or
as "XI". See NOTE 2 for information related to some specific country codes.

See the Commission's website for information on the decentralised procedure.

• EU authorisation procedures - Traditional use registration for herbal medicinal products

(11): must be selected when entering herbal medicinal products registered under the Traditional
Herbal Medicines Registration Scheme.

− The authorisation country code (AP.12.1) must be specified as one of the EEA countries and/or
as "XI". See NOTE 2 for information related to some specific country codes.

• EU authorisation procedures - Simplified registration procedure for homeopathic

medicinal products (12): must be selected when entering homeopathic medicinal products
registered through the simplified registration procedure.

− The authorisation country code (AP.12.1) must be specified as one of the EEA countries and/or
as "XI". See NOTE 2 for information related to some specific country codes.

• EU other approval/authorisation procedure (13) must be selected in case of voluntary

submission of medicinal product information not authorised in the European Union (EU) and the
European Economic Area (EEA), and administered under emergency use, compassionate use, or
other national schemes.

− The authorisation country code (AP.12.1) must be specified as one of the EEA countries and/or
as "XI". See NOTE 2 for information related to some specific country codes.

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EMA/135580/2012 Page 42/200
NOTE 3

• In case of voluntary submission of medicinal product falling outside the scope of Article 57(2)
requirements and for which a marketing authorisation is not granted (e.g., herbal medicinal
product with no registration) the value "EU authorisation procedures - National Procedure (4)"
should be selected.

− Indication of the legal basis or the medicinal product type must be provided in data fields
"Legal Basis" (AP.12.13) and "Medicinal Product Type" (AP.12.MPTs).

− The "Authorisation country code" (AP.12.1) must be specified as one of the EEA countries
and/or as "XI". See NOTE 2 for information related to some specific country codes.

• In case of voluntary submission of information on medicinal products without a marketing

authorisation granted in the EU/EEA, which are provided under emergency use, compassionate use
or other national schemes, and which fall outside the scope of Article 57(2) requirements, the
value "EU other approval/authorisation procedure (13)" should be selected.

− Indication of the legal basis or the medicinal product type must be provided in data fields
"Legal Basis" (AP.12.13).

− The "Authorisation country code" (AP.12.1) must be specified as one of the EEA countries
and/or as "XI". See NOTE 2 for information related to some specific country codes.

1.2.12.3. Authorisation status (AP.12.3)

The status of the authorisation of a medicinal product must be specified.

The information stated in this field does not refer to the marketing status (i.e., marketed/not
marketed).

List of available authorisation status values can be found in the 'eXtended Eudravigilance Product
Dictionary (XEVMPD) authorisation status' list published on the ‘Guidance documents related to data
submission for authorised medicines’ webpage.

• Valid (1): applicable to a medicinal product for which the marketing authorisation is valid.

• Valid - Suspended (2): applicable to a medicinal product for which the marketing authorisation is
suspended. When the suspension has been lifted, the status of the medicinal product should be
changed either to a "valid" status or to a "not valid" status (e.g., revoked or withdrawn) as
applicable.

• Not valid - Withdrawn by marketing authorisation holder (3): applicable to a medicinal

product for which the marketing authorisation has been withdrawn by the marketing authorisation
holder.

• Not valid - Revoked by Competent Authority (4): applicable to a medicinal product for which
the marketing authorisation has been revoked by a Competent Authority/European Commission.

• Not valid - Not renewed by Competent Authority (5): applicable to a medicinal product for
which the marketing authorisation has not been renewed by the Competent Authority/European
Commission.

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• Not valid - Not submitted for renewal by marketing authorisation Holder (6): applicable to
a medicinal product for which the marketing authorisation holder did not submit a request for
renewal.

• Not valid - Expired due to Sunset Clause (7): applicable to a medicinal product for which the
marketing authorisation has expired due to the Sunset Clause.

• Valid – Renewed/Varied Marketing Authorisation (8): applicable to a medicinal product for

which the marketing authorisation has been renewed or varied and a new marketing authorisation
number has been assigned by the National Competent Authority.

• Valid - Transferred Marketing Authorisation (9): applicable to a medicinal product for which
the marketing authorisation was transferred from one marketing authorisation holder to another.

This authorisation status is to be used by the new MAH as part of the transfer of marketing
authorisation process.

• Not Valid – Superseded by Marketing Authorisation Renewal/Variation (10): applicable to

a medicinal product for which the marketing authorisation has been renewed or varied and a new
marketing authorisation number has been assigned by the National Competent Authority.

• Not Valid - Superseded by Marketing Authorisation Transfer (11): applicable to a medicinal

product for which the marketing authorisation was transferred from one marketing authorisation
holder to another.

This authorisation status is to be used by the former MAH as part of the transfer of marketing
authorisation process.

• ‘Valid – pending national phase’ (12): applicable to a medicinal product for which the
marketing authorisation under the mutually recognised and/or decentralised procedure is pending.

This authorisation status is to be used only when the medicinal product has been authorised by the
Reference Member State but is under evaluation in the Concerned Member States. The
authorisation status in the RMS should be Valid (1) and Valid – pending national phase (12) in the
CMS(s).

Not applicable for pending pure national authorisation procedure approvals.

This value will be made available for use in EVWEB from mid-January 2025.

NOTE 4

AMPs for which the marketing authorisation was transferred to another MAH should be submitted in the
XEVMPD with the authorisation status "Valid – Transferred Marketing Authorisation" (9). It can change
from "Valid – Transferred Marketing Authorisation" to "Valid – Suspended" and then back to "Valid –
Transferred Marketing Authorisation".

"Valid – Transferred Marketing Authorisation" can also change to "Valid – Renewed/Varied Marketing
Authorisation" but not back to "Valid – Transferred Marketing Authorisation".

Please note that when a marketing authorisation was transferred the authorisation status can never be
"Valid" when the new MAH received the previous EV Code (from the previous MAH).

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1.2.12.4. Authorisation number (AP.12.4)

Marketing authorisation number assigned by the Competent Authority and as stated in the
SmPC must be specified – See EXAMPLE 7.

Only one number must be stated in this data element.

If multiple authorisation numbers are stated in the SmPC [e.g., in section 8. Marketing authorisation
number(s) of the corresponding SmPC], multiple product entities should be submitted in the XEVMPD.
Package size corresponding to the individual authorisation number must be included in the "Package
Description" field (AP.13.7) in accordance with information in the Pack Size Submissions: from XEVMPD
to PMS presentation. See EXAMPLE 8.

If the authorisation numbers are specified in the format XXXX/XXX-XXX (e.g., 1234/001-003) then
multiple authorised medicinal product entities should be submitted, each referencing the specific
authorisation number (i.e., 1234/001, 1234/002, 1234/003).

Scenario 1:

The SmPC of a medicinal product authorised in Romania states the following information:
1. Name of the medicinal product
Paracetamol Plus PharmaK 500 mg comprimate
8. Authorisation number(s)
1234/2014/01-04

Based on the above example, four medicinal product entities should be submitted in the XEVMPD, each
referencing the applicable authorisation number (i.e., 1234/2014/01, 1234/2014/02, 1234/2014/03,
1234/2014/04).

Scenario 2:

The SmPC of a centrally authorised medicinal product states the following information:
1. Name of the medicinal product
Macys 100 mg tablets
8. Authorisation number(s)
EU/1/13/016/003-007

Based on the above example, five medicinal product entities should be submitted in the XEVMPD, each
referencing the applicable authorisation number (i.e., EU/1/13/016/003, EU/1/13/016/004,
EU/1/13/016/005, EU/1/13/016/006, EU/1/13/016/007).

For medicinal products authorised nationally in France; a 'package number' is stated in section 8 of
the SmPC but it does not correspond to the marketing authorisation number (i.e. NL number) stated in
the marketing authorisation document. Taking into consideration that the NL number is confidential,
and, as per the request of the French National Competent Authority, from January 2025, MAHs are
required to reference either the CIS number (covering all pack sizes) or the CIP number (assigned to
each individual pack size) in the ‘Authorisation number’ field of the product entry in the XEVMPD:

• If the MAH wishes to submit in the XEVMPD one product record for all pack sizes, then the CIS
number must be referenced in the ‘Authorisation number’ field. The number is formed of 8
characters with the format 6nnnnnnn.

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• If the MAH wishes to submit in the XEVMPD one product record for each individual pack size, then
the CIP number must be referenced in the ‘Authorisation number’ field. The number is formed of
13 characters with the format 34009nnnnnnnn.

Records already submitted to XEVMPD and referencing the NL number should therefore be updated by
the MAH to reflect either the CIP or CIS number as applicable.

For centrally authorised medicinal products the format of the authorisation number must be
"EU/1/YY/NNN/NNN" or "EU/1/YY/NNNN/NNN" (as applicable) – see EXAMPLE 5 and EXAMPLE 9.

For centrally authorised medicinal products (CAPs) the marketing authorisation number as assigned by
the European Commission and as stated in section 8. Marketing authorisation number(s) of the SmPC
must be entered in the "Authorisation Number" field (AP.12.4) as well as in the "EU Number" field
(AP.12.8) – See EXAMPLE 5 and EXAMPLE 9.

EXAMPLE 7

The SmPC of a medicinal product with a valid MA in Northern Ireland states the following information:
1. Name of the medicinal product
Kassa tablets
8. Authorisation number(s)
PL 1234/0001

Based on the information stated in section 8. Authorisation number(s) of the SmPC (i.e., one
authorisation number listed), one medicinal product entries should be submitted to the XEVMPD:
"Full Presentation Name" (AP.13.1) = Kassa tablets
"Authorisation Number" (AP.12.4) = PL 1234/0001

EXAMPLE 8

The SmPC of a medicinal product with a valid MA in Northern Ireland states the following information:
1. Name of the medicinal product
Triamcinolone acetonide tablets
8. Authorisation number(s)
PL 12345/0001
PL 12345/0002

Based on the information stated in section 8. Authorisation number(s) of the SmPC (i.e., two
authorisation numbers listed), two medicinal product entries should be submitted to the XEVMPD:

AMP entity 1:
"Full Presentation Name" (AP.13.1) = Triamcinolone acetonide tablets
"Authorisation Number" (AP.12.4) = PL 12345/0001

AMP entity 2:
"Full Presentation Name" (AP.13.1) = Triamcinolone acetonide tablets

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"Authorisation Number" (AP.12.4) = PL 12345/0002

EXAMPLE 9

AMP authorised in the centralised procedure with EU number: EU/1/23/4569/789 and EMEA number:
EMEA/H/C/123456 should be entered in the corresponding fields as follows:

Authorisation Procedure" (AP.12.2) = EU authorisation procedures - Centralised Procedure

"Authorisation Number" (AP.12.4) = EU/1/23/4569/789
"MRP/DCP/EMEA Number" (AP.12.7) = EMEA/H/C/123456
"EU Number" (AP.12.8) = EU/1/23/4569/789

1.2.12.5. Authorisation/renewal date (AP.12.5)

The date when the first authorisation was granted by the authorising body, or the date
when the renewal was granted (whichever is the latest), must be specified in line with
section 9. Date of first authorisation/renewal of the authorisation of the SmPC.

The authorisation date is linked to the regulatory status of the medicinal product:

• The date when the first authorisation was granted by the Authorising Body must be specified
when there was no prior renewal of the MA, and the "Authorisation Status" (AP.12.3) is entered as:

− "Valid (1); or

− "Valid - Transferred Marketing Authorisation (9)".

• The date when the renewal was granted by the Authorising Body must be specified as applicable
when the "Authorisation Status" (AP.12.3) is entered as:

− "Valid (1); or

− "Valid – Renewed/Varied Marketing Authorisation (8)"

The authorisation/renewal date is to be specified consisting of year, month and day or year and month.

It is possible to specify a future date in this data element; this date must be stated in the attachment
referenced in the product entity.

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If section 9. of the SmPC does not state the date of renewal, the following guidance should be
followed:

Following a renewal of the marketing

authorisation (MA), we need to amend our
AMP entity in the XEVMPD.
Which document do we attach and
where do we reference the renewal
date?

Do you have the ➢ Attach the updated SmPC; and

corresponding version Yes ➢ Enter the date of the renewal
of the SmPC stating the from section 9. of the SmPC in
latest renewal date? the “Authorisation/Renewal date”
field

No

➢ Reference the previously

submitted SmPC; and
➢ Attach the document granting Yes
Did the NCA issue a
the renewal of the MA; and document granting the
➢ Enter the date of renewal in the renewal of the MA?
“Authorisation/Renewal date”
field
No

➢ Reference the previously

submitted SmPC; and
➢ Enter the date of renewal in the
“Authorisation/Renewal date”
field

1.2.12.6. Authorisation/renewal date format (AP.12.6)

Format of the authorisation/renewal date should correspond to "102" for "CCYYMMDD" or

to "610" corresponding to "CCYYMM".

1.2.12.7. MRP/DCP/EMEA number (AP.12.7)

MRP/DCP/EMEA Procedure Number must be specified depending on the applicable

authorisation procedure.

Whilst the format of the number for a specific procedure is a unique combination of six sections, i.e.,
CC/D/nnnn/sss/X/vvv where the "X" represents the type of marketing application to the medicinal
product, the number stated in the XEVPRM field "MRP/DCP/EMEA number" (AP.12.7) should not
contain the reference to the marketing application (i.e., "MR", "DC" etc.) since the type of marketing
authorisation is in the XEVMPD captured in the "Authorisation procedure" field (AP.12.2).

The format of the MRP/DCP number should be the same as in the SmPC (if included) without "MR",
"DC" etc. or as stated in the MR Index on the HMA website, which is a combination of only four
sections (CC/D/nnnn/sss).

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The procedure tracking number is always a four-digit number, and the strength number is a three-digit
number.

• Mutual recognition procedure number must be specified when the "Authorisation Procedure"
(AP.12.2)" is entered as "EU authorisation procedures - Mutual Recognition Procedure (3)" – See
EXAMPLE 10.
− The MR number for a specific AMP can be found in the MR Index on the Heads of Medicines
Agency's website and/or can be included in the SmPC.
− The format of the MRP number should be the same as in the SmPC (if included, without the
reference to the marketing application, i.e., the text "/MR" or "E") or as stated in the MR Index
on the Heads of Medicines Agency's website, i.e., without the reference to the marketing
application (i.e., the text "/MR" or "E").

• Repeat use procedure number should be entered in the "MRP/DCP/EMEA number" field
(AP.12.7) as stated in the MR Index on the HMA website, i.e., as a combination of only four
sections (CC/D/nnnn/sss).

− In case of RUP or line extensions this information is not to be reflected in the procedure
number (no addition behind the procedure number UK/H/0234/001/xx => no /xx).

EXAMPLE 10

AMP authorised in mutual recognition procedure with MR number: SE/H/1111/222 and national
authorisation number: PL 12345/123 should be entered in the corresponding fields as follows:

"Authorisation Procedure" (AP.12.2) = EU authorisation procedures - Mutual Recognition

Procedure
"Authorisation Number" (AP.12.4) = PL 12345/123
"MRP/DCP/EMEA Number" (AP.12.7) = SE/H/1111/222
"EU Number" (AP.12.8) = <this field should be left blank>

• Decentralised authorisation procedure number must be specified when the "Authorisation

Procedure" (AP.12.2)" is entered as "EU authorisation procedures - Decentralised Procedure (7)" –
See EXAMPLE 11.
− DCP number for a specific AMP can be found in the MR Index on the Heads of Medicines
Agency's website and/or can be included in the SmPC.
− The format of the DCP number should be the same as in the SmPC (if included, without the
reference to the marketing application, i.e., the text "/DC") or as stated in the MR Index on the
Heads of Medicines Agency's website, i.e., without the reference to the marketing application
(i.e., the text "/DC").

EXAMPLE 11

An AMP authorised in the Czech Republic in decentralised procedure with DCP number:
DE/H/1111/001/DC and with the authorisation number 11/222/03-C should be entered in the
corresponding fields as follows:

"Authorisation Procedure" (AP.12.2) = EU authorisation procedures - Decentralised Procedure

"Authorisation Number" (AP.12.4) = 11/222/03-C
"MRP/DCP/EMEA Number" (AP.12.7) = DE/H/1111/001

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 "EU Number" (AP.12.8) = <this field should be left blank>

EMEA procedure number (i.e., EMA "Product number" as referred to/referenced on the EMA
website) must be specified when the "Authorisation Procedure" (AP.12.2)" is entered as "EU
authorisation procedures - Centralised Procedure (1)" – See EXAMPLE 9.
− The format of the EMEA procedure number should be EMEA six-digit procedure number (i.e.,
EMEA/H/C/123456) of a specific CAP, as referenced on the EMA website.

1.2.12.8. EU number (AP.12.8)

The marketing authorisation number as assigned by the EU Commission and as stated in

section 8. Marketing authorisation number(s) of the SmPC must be specified.

When the "Authorisation Procedure" (AP.12.2)" is entered as "EU authorisation procedures -

Centralised Procedure (1)", the "EU Number" field (AP.12.8), as well as the "Authorisation Number"
field (AP.12.4) must be populated with the EU number.

The format of the EU number must be "EU/1/YY/NNN/NNN" or "EU/1/YY/NNNN/NNN" (as applicable) -

See EXAMPLE 5 and EXAMPLE 9.

1.2.12.9. Orphan drug status (AP.12.9)

The value indicating whether the AMP is considered an orphan drug medicine must be
specified.

The disease (orphan) designation of a medicinal product from the European Medicines Agency's
Committee on Orphan Medicinal Products (COMP) must be specified unless the operation type is
'Nullification (4)' or 'Invalidate MA (6)'. One of the following values is to be specified as applicable:

1 = Yes

2 = No

1.2.12.10. Additional monitoring (AP.12.10)

The value indicating whether the AMP is subject to additional monitoring must be specified.

Indication for additional monitoring (black triangle/symbol) for a specific AMP can be found in the
SmPC of the authorised medicinal product.

Indication whether the medicinal product is subject to additional monitoring must be specified
referencing one of the available values:

1 = medicinal product is subject to additional monitoring

2 = medicinal product is NOT subject to additional monitoring

1.2.12.11. Invalidated date format (AP.12.11)

Format of the Invalidated date should correspond to "102" for "CCYYMMDD".

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1.2.12.12. Invalidated date (AP.12.12)

The date as of when the "Authorisation status" (AP.12.3) "Not valid" or "Valid - Suspended"
becomes effective must be specified depending on the applicable authorisation status.

• The date of expiry of the marketing authorisation must be entered in the "Invalidated date" field
(AP.12.12) when one of the below values is used in the "Authorisation status" field (AP.12.3):

− Not valid - Withdrawn by marketing authorisation holder (3)

− Not valid - Revoked by Competent Authority (4)

− Not valid - Not renewed by Competent Authority (5)

− Not valid - Not submitted for renewal by marketing authorisation Holder (6)

− Not valid - Expired due to Sunset Clause (7)

• The date of suspension of the marketing authorisation must be entered in the "Invalidated date"
field (AP.12.12) when the value "Valid – Suspended (2)" is specified in the "Authorisation status"
field (AP.12.3).

• The date of transfer of the marketing authorisation must be entered in the "Invalidated date"
field (AP.12.12) when the value "Not Valid – Superseded by Marketing Authorisation Transfer (11)"
is specified in the "Authorisation status" field (AP.12.3).

• The date of renewal of the marketing authorisation must be entered in the "Invalidated date"
field (AP.12.12) when the value "Not Valid – Superseded by Marketing Authorisation
Renewal/Variation (10)" is specified in the "Authorisation status" field (AP.12.3).

• No value should be entered in the "Invalidated date" field (AP.12.12) when the marketing
authorisation remains valid after the suspension of a marketing authorisation has been lifted - the
authorisation status should be changed to one of the other "valid" values (1, 8 or 9) and the date
when the suspension was lifted must be specified in the "Info Date" field (AP.11).

For centrally authorised medicinal products, see the below webpages for further information: 'Renewal
and annual re-assessment of marketing authorisation' webpage and ‘Sunset clause monitoring:
Regulatory and procedural guidance’ webpage.

It is not technically possible to specify a future date in this data element (i.e., the date must either be
the same as the date of submission or precede the date of submission of your XEVPRM).

1.2.12.13. Legal basis (AP.12.13)

The description of the legal basis for the marketing authorisation must be specified based
on the available values.

One of the available values must be selected:

• Full application (Article 8(3) of Directive No 2001/83/EC) (1)

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• Generic application (Article 10(1) of Directive No 2001/83/EC) (2)

• Hybrid application (Article 10(3) of Directive No 2001/83/EC) (3)

• Similar biological application (Article 10(4) of Directive No 2001/83/EC) (4)

• Well-established use application (Article 10a of Directive No 2001/83/EC) (5)

• Fixed combination application (Article 10b of Directive No 2001/83/EC) (6)

• Informed consent application (Article 10c of Directive No 2001/83/EC) (7)

• Traditional use registration application for a herbal medicinal product

(Article 16a of Directive No 2001/83/EC) (8)

• Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No

2001/83/EC) (9)

• Medicinal product authorised according to Article 126a of Directive No 2001/83/EC (10)

• Application according to Article 58 of Regulation (EC) No 726/2004 (11)

• Authorisation according to Article 5(1) of Directive 2001/83/EC (12);

• Authorisation according to Article 5(2) of Directive 2001/83/EC (13);

• Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC (14);

• Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC (15);

• Available under Article 83(2) of Regulation (EC) No 726/2004 (16).

NOTE 5

As regard medicinal products for which the legal basis of the marketing authorisation predates
Directive 2001/83/EC: taking into account that the pharmaceutical Acquis communautaire has
been amended over time, the legal basis applicable under the current Union legal framework
which corresponds to the legal basis in the legislation that was applicable at time of
submission of your application must be specified.

NOTE 6

• Where the "Authorisation procedure" (AP.12.2) is specified as "EU authorisation procedures -

Traditional use registration for herbal medicinal products" (11), the Legal basis should also be
selected as "Traditional use registration application for a herbal medicinal product
(Article 16a of Directive No 2001/83/EC)" (8);

• Where the "Authorisation procedure" (AP.12.2) is specified as "EU authorisation procedures -

Simplified registration procedure for homeopathic medicinal products" (12) the Legal basis should
also be selected as "Simplified registration application for a homeopathic medicinal product (Article
14 of Directive No 2001/83/EC)" (9).

• Where the "Authorisation procedure" (AP.12.2) is specified as "EU other approval/authorisation

procedure" (13), one of the below listed Legal Basis should be selected as applicable:

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 − Authorisation according to Article 5(1) of Directive 2001/83/EC (12);

− Authorisation according to Article 5(2) of Directive 2001/83/EC (13);

− Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC (14);

− Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC (15);

− Available under Article 83(2) of Regulation (EC) No 726/2004 (16).

1.2.12.14. Medicinal product types (AP.12.MPT.1)

The description of the type(s) of the medicinal product must be specified based on the
available values. If multiple values apply to the same AMP, then multiple values must be
selected (this is repeatable field).

The following values are available:

• Authorised homeopathic medicinal product (1)

• Authorised herbal medicinal product (2)

• Parallel Distributed/Imported medicinal product (Article 76(3) and (4) of Directive No 2001/83/EC)
(3)

• Conditional Marketing Authorisation (Article 14 (7) of Regulation (EC) No 726/2004) (4)

• Exceptional Circumstances Marketing Authorisation (Article 14 (8) of Regulation (EC) No 726/2004

or Article 22 of Directive 2001/83/EC) (5)

• Paediatric Use Marketing Authorisation (PUMA) (Article 30 of Regulation (EC) No 1901/2006) (6)

• Other (7)

The value "Other" should be specified if none of the other available values are applicable.

1.2.13. AMP - Presentation Name element structure (AP.13)

The presentation name elements in data fields AP.13.1 - AP.13.6 must be entered in the
language of the country where the marketing authorisation applies in accordance with the
referenced SmPC.

List of official languages per country can be found on the Agency's website.

See also:

• Table 1a- Authorised Medicinal Product – language requirements; and

• Table 1b - Requirements for AMP records and attachments for countries with more than one
national language for related information.

Where, in exceptional circumstances, the national SmPC for non-centrally authorised products
(MRPs/DCPs/NAPs) is not available, a similar text (i.e., the English common text, package information
leaflet or other similar text as authorised by the Authorising Body) can be used as an attachment for

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the submission in the XEVMPD. The data elements AP.13.1 - AP.13.6 must however be provided in the
language of the country where the marketing authorisation applies.

The data elements AP.13.1 - AP.13.6 must however be provided in the language of the country where
the marketing authorisation applies.

See also NOTE 15 for related information.

• For centrally authorised products, the SmPC to be used for reference must be in English and
the data elements AP.13.1 - AP.13.6 must be provided in English.

• For medicinal products authorised in Iceland, Liechtenstein, and Norway in centrally

authorised procedure:

− The data elements AP.13.1 - AP.13.6 must be provided in in English2;

− The SmPC of the medicinal product should be provided in English; when an SmPC or a PIL is
also available in the local language this document should also be provided.

Presentation Name elements structure:

Additional examples are also available in the 'European Medicines Agency splitting of the full
presentation name of the medicinal product best practice: Procedure and principles to handle product

2
Whilst different guidance on the provision/population of the name elements for products authorised centrally in IS/LI/NO
was issued in the past, subsequent experience over time showed that the provision of the name in English is preferable in
order to allow the Agency group similar CAPs based on the product name information. MAHs are not required to perform a
dedicated update of their product entities to amend this information as this can be done as part of a regular maintenance.

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name in the EudraVigilance Medicinal Product Dictionary (XEVMPD)' document published in the "Data
Quality-control methodology" section of the 'Guidance documents related to data submission for
authorised medicines' webpage.

1.2.13.1. Full Presentation Name (AP.13.1)

The medicinal product name stated in Section 1. Name of the medicinal product of the
corresponding SmPC must be specified.
See EXAMPLE 12.

According to the QRD templates, normally the trademark symbol is not to be included in medicinal
product name stated in Section 1. Name of the medicinal product of the corresponding SmPC.
However, if a trademark symbol (e.g., ®) is included in section 1 of the SmPC, then this trademark
symbol must also be included in the medicinal product name entered in the data element AP.13.1. –
see EXAMPLE 13 and EXAMPLE 16.

EXAMPLE 12

The SmPC of a medicinal product authorised in Italy states the following information:
1. DENOMINAZIONE DEL MEDICINALE
ProductXYZ 40 mg Compresse rivestite

"Full Presentation Name" (AP.13.1) = ProductXYZ 40 mg Compresse rivestite

EXAMPLE 13

The SmPC of a medicinal product authorised in Malta states the following information:
1. Name of the medicinal product
DrugABC® 40 mg tablets

"Full Presentation Name" (AP.13.1) = DrugABC® 40 mg tablets

1.2.13.2. Product Short Name (AP.13.2)

If included in the medicinal product name stated in Section 1. Name of the medicinal
product of the SmPC, then the invented (trade) name part with any other designation except
the strength/pharmaceutical form must be specified.

In accordance with the definition provided in Article 1(20) of Directive 2001/83/EC, the name of the
medicinal product may be an invented name - if this is the case, the invented name should be
provided. See EXAMPLE 14.

• If the invented name in Section 1. Name of the medicinal product of the SmPC, includes additional
designations, these must also be specified.

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 Designations may refer to target population (e.g., adult, paediatric, children), administration
device (e.g., breezehaler), potency of the product (e.g., EXTRA, FORTE, PLUS, numbers not
referring to the strength), mode of action (e.g., Express), indication/intended use (e.g., Migraine),
flavour/formulation part (e.g., strawberry, sugar free), time/period part (e.g., SR) etc. These
designations, as well as any other qualifiers facilitating the precise identification of the product
concerned for pharmacovigilance purposes must be provided in the "Product Short Name" field
(AP.13.2) (e.g., Plus, Zydis) – see EXAMPLE 15 and EXAMPLE 17.

− If the additional designation is a number, which refers to the strength, the number referring to
the strength must not be provided in the "Product Short Name" (AP.13.2) field – see EXAMPLE
15.

− If the additional designation is a number, which does not refer to the strength, the number
must be provided in the "Product Short Name" field (AP.13.2) – see EXAMPLE 29.

− If the additional designation is a number, which refers to a ratio (e.g., in case of insulin), the
number must be provided in the "Product Short Name" field (AP.13.2) if the invented name is
available – see EXAMPLE 16.

• If no invented (trade) name is included in the medicinal product name stated in Section 1. Name of
the medicinal product of the SmPC, then the field "Product Short Name" (AP.13.2) must be left
blank – see EXAMPLE 19.

EXAMPLE 14

The SmPC of a medicinal product authorised in Malta states the following information:
1. Name of the medicinal product
ProdXYZ tablets

"Full Presentation Name" (AP.13.1) = ProdXYZ tablets

"Product Short Name" (AP.13.2) = ProdXYZ

EXAMPLE 15

The SmPC of a medicinal product authorised in Italy states the following information:
1. DENOMINAZIONE DEL MEDICINALE
XYZ Plus 40 Compresse rivestite
The number "40" does refer to the strength (as section 2. Qualitative and Quantitative composition of
the SmPC indicates that the strength of the active ingredient is 40 mg), therefore, the following
approach must be adopted:

"Full Presentation Name" (AP.13.1) = XYZ Plus 40 Compresse rivestite

"Product Short Name" (AP.13.2) = XYZ Plus

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EXAMPLE 16

The SmPC of a medicinal product authorised in Ireland states the following information:
1. Name of the medicinal product
Prodemaz® Insulin Porcine 30/70 Mix

"Full Presentation Name" (AP.13.1) = Prodemaz® Insulin Porcine 30/70 Mix

"Product Short Name" (AP.13.2) = Prodemaz 30/70 Mix

EXAMPLE 17

The SmPC of a medicinal product authorised in Malta states the following information:
1. Name of the medicinal product
ZYX Strawberry 50 mg Capsules for Children

"Full Presentation Name" (AP.13.1) = ZYX Strawberry 50 mg Capsules for Children

"Product Short Name" (AP.13.2) = ZYX Strawberry for Children

1.2.13.3. Product INN/Common Name (AP.13.3)

If the medicinal product name stated in Section 1. Name of the medicinal product of the
SmPC includes the INN/Common/Scientific name of the medicinal product, then the
INN/Common/Scientific name as stated in Section 1. of the SmPC must be specified.

If the medicinal product name stated in Section 1. of the SmPC is not an invented (trade
name) name, then the INN/Common/Scientific name of the medicinal product must be
specified as stated in Section 1. of the SmPC with any other designation except the
strength/pharmaceutical form. See EXAMPLE 18.

In accordance with the definition provided in Article 1(20) of Directive 2001/83/EC, the medicinal
product name may be either the INN/common name, or a common or scientific name accompanied by
a trademark or the name of the marketing authorisation holder.

• If no invented name is included and the name of the medicinal product stated in Section 1. Name
of the medicinal product of the SmPC is the INN/common name/ scientific name accompanied by a
trademark, the INN/common name/ scientific name accompanied by a trademark must both be
provided – see EXAMPLE 20.

• If no invented name is included and the name of the medicinal product stated in Section 1. Name
of the medicinal product of the SmPC is the INN/common name/ scientific name accompanied by
the name of the marketing authorisation holder, the INN/common name/ scientific name must be
provided in this field, whereas the name of the marketing authorisation holder must be provided in
the "Product Company Name" field (AP.13.4) – see EXAMPLE 19.

• If no invented name is stated and the INN/common name/ scientific name in Section 1. Name of
the medicinal product of the SmPC includes additional designations, these must also be specified.

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 Designations may refer to the target population (e.g., adult, paediatric, children), administration
device, potency of the product (e.g., EXTRA, FORTE, PLUS, numbers not referring to the strength),
mode of action (e.g., Express), indication/intended use (e.g., Migraine), Flavour/formulation part
(e.g., strawberry, sugar free), Time/Period part (e.g., SR). These designations, as well as any
other qualifiers facilitating the precise identification of the product concerned for pharmacovigilance
purposes must be provided in "Product INN/Common Name" field (AP.13.3) - see EXAMPLE 22.

− If the additional designation is a number, which refers to the strength, the number referring to
the strength must not be provided in the "Product INN/Common Name" field (AP.13.3) - see
EXAMPLE 25.

− If the additional designation is a number, which does not refer to the strength, the number
must be provided in the "Product INN/Common Name" field (AP.13.3) – see EXAMPLE 26.

− If the additional designation is a number, which refers to a ratio (e.g., in case of insulin), the
number must be provided in the "Product INN/Common Name" field (AP.13.3) – see EXAMPLE
27 .

• If the scientific or common (i.e., INN) name is not part of the medicinal product name stated in
Section 1. Name of the medicinal product of the SmPC, then the field "Product INN/Common
Name" (AP.13.3) should be left blank - see EXAMPLE 21.

EXAMPLE 18

The SmPC of a medicinal product authorised in Italy states the following information:
1. DENOMINAZIONE DEL MEDICINALE
XYZ® (triamcinolone acetonide) 40 mg Compresse rivestite

"Full Presentation Name" (AP.13.1) = XYZ® (triamcinolone acetonide) 40 mg Compresse rivestite

"Product Short Name" (AP.13.2) = XYZ

"Product INN/Common Name" (AP.13.3) = triamcinolone acetonide

EXAMPLE 19

The SmPC of a medicinal product authorised in Germany states the following information:
1. BEZEICHNUNG DES ARZNEIMITTELS
Diclofenac PharmaABC 50mg Filmtabletten

7. INHABER DER ZULASSUNG

ZPharma GmbH

"Full Presentation Name" (AP.13.1) = Diclofenac PharmaABC 50mg Filmtabletten

"Product Short Name" (AP.13.2) = <this field should be left blank>

"Product INN/Common Name" (AP.13.3) = Diclofenac

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"Product Company Name" (AP.13.4) = PharmaABC

EXAMPLE 20

The SmPC of a medicinal product authorised in Ireland states the following information:
1. Name of the medicinal product
Diclofenac Dispersible PharmaK 70% w/w Gel

"Full Presentation Name" (AP.13.1) = Diclofenac Dispersible PharmaK 70% w/w Gel
"Product Short Name" (AP.13.2) = <this field should be left blank>

"Product INN/Common Name" (AP.13.3) = Diclofenac Dispersible

"Product Company Name" (AP.13.4) = PharmaK

EXAMPLE 21

The SmPC of a medicinal product authorised in the Ireland states the following information:

1. Name of the medicinal product

ProdXYZ tablets

"Full Presentation Name" (AP.13.1) = ProdXYZ tablets

"Product Short Name" (AP.13.2) = ProdXYZ

"Product INN/Common Name" (AP.13.3) = <this field should be left blank>

EXAMPLE 22

The SmPC of a medicinal product authorised in Ireland states the following information:

1. Name of the medicinal product

Ibuprofen Extra Forte 400 mg Liquid Capsules

7. Marketing Authorisation Holder

Pharma XYZ Ltd.

"Full Presentation Name" (AP.13.1) = Ibuprofen Extra Forte 400 mg Liquid Capsules

"Product Short Name" (AP.13.2) = <this field should be left blank>

"Product INN/Common Name" (AP.13.3) = Ibuprofen Extra Forte

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"Product Company Name" (AP.13.4) = Pharma XYZ

1.2.13.4. Product Company Name (AP.13.4)

If included in the medicinal product name stated in Section 1. Name of the medicinal
product of the SmPC, the Company name part of the medicinal product name without any
other designations such as trademark, strength or pharmaceutical form must be specified.

In accordance with the definition provided in Article 1(20) of Directive 2001/83/EC, the name of the
medicinal product may include the name of the marketing authorisation holder. If this is the case, the
exact name of the marketing authorisation holder as stated in Section 1. Name of the medicinal
product of the SmPC, and as specified in the Full Presentation Name (AP.13.1) must be specified – see
EXAMPLE 23.

• If the company name is not included in the medicinal product name stated in Section 1. Name of
the medicinal product of the SmPC and the invented (trade) name is present, then the field
"Product Company Name" (AP.13.4) must be left blank – see EXAMPLE 24.

• If the company name is not included in the medicinal product name stated in Section 1. Name of
the medicinal product of the SmPC and the invented (trade) name is NOT present, then the field
"Product Company Name" (AP.13.4) must be populated with the MAH name stated in Section 7.
Marketing Authorisation Holder of the SmPC without the description of the legal status (e.g., Ltd,
Limited, S.p.A., GmbH etc.) – see EXAMPLE 25 and EXAMPLE 26.

• The company name and MAH name may not be identical – see EXAMPLE 19.

EXAMPLE 23

The SmPC of a medicinal product authorised in Malta states the following information:
1. Name of the medicinal product
ProductX PharmaZ capsules

"Full Presentation Name" (AP.13.1) = ProductX PharmaZ capsules

"Product Short Name" (AP.13.2) = ProductX

"Product INN/Common Name" (AP.13.3) = <this field should be left blank>

"Product Company Name" (AP.13.4) = PharmaZ

EXAMPLE 24

The SmPC of a medicinal product authorised in Germany states the following information:
1. BEZEICHNUNG DES ARZNEIMITTELS
DrugLV Filmtabletten

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"Full Presentation Name" (AP.13.1) = DrugLV Filmtabletten

"Product Short Name" (AP.13.2) = DrugLV

"Product INN/Common Name" (AP.13.3) = <this field should be left blank>

"Product Company Name" (AP.13.4) = <this field should be left blank>

EXAMPLE 25

The SmPC of a medicinal product authorised in Italy states the following information:
1. DENOMINAZIONE DEL MEDICINALE
Amoxicillina 500 capsule

7. TITOLARE DELL’AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO

PharmaXYZ S.r.l.

The number "500" does refer to the strength (as section 2. Qualitative and Quantitative composition of
the SmPC indicates that the strength of the active ingredient is 500 mg), therefore the following
approach has to be adopted:

"Full Presentation Name" (AP.13.1) = Amoxicillina 500 capsule

"Product Short Name" (AP.13.2) = <this field should be left blank>

"Product INN/Common Name" (AP.13.3) = Amoxicillina

"Product Company Name" (AP.13.4) = PharmaXYZ

"Product Strength Name" (AP.13.5) = 500

1.2.13.5. Product Strength Name (AP.13.5)

If included in the medicinal product name stated in Section 1. Name of the medicinal
product of the SmPC, the strength part of the medicinal product name without any other
designations must be specified.

• If the strength is not included in the medicinal product name stated in section 1. Name of the
medicinal product of the SmPC, then the field "Product Strength Name" (AP.13.5) must be left
blank – see EXAMPLE 28.

• If the strength is not included in the medicinal product name stated in section 1. Name of the
medicinal product of the SmPC and a vaccine season (e.g., 2013/2014) is stated in section 1.
Name of the medicinal product of the SmPC, then the field "Product Strength Name" (AP.13.5)
must specify the vaccine season (e.g., 2013/2014). See EXAMPLE 35 - Presentation name
elements – vaccines.

• If both, the strength and the vaccine season are included in the medicinal product name stated in
section 1. Name of the medicinal product of the SmPC, then the field "Product Strength Name"

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 (AP.13.5) must specify only the strength - see EXAMPLE 36 - Presentation name elements –
vaccines.

• If the medicinal product name stated in Section 1. Name of the medicinal product of the SmPC
contains a number, which is not referring to the strength then the field "Product Strength Name"
(AP.13.5) must be left blank – see EXAMPLE 29.

EXAMPLE 26

The SmPC of a medicinal product authorised in Italy states the following information:
1. DENOMINAZIONE DEL MEDICINALE
Triamcinolone acetonide 40 Compresse rivestite
7. TITOLARE DELL'AUTORIZZAZIONE ALL'IMMISIONE IN COMMERCIO
PharmaABC S.p.A.

The number "40" does not refer to the strength (as section 2. Qualitative and Quantitative composition
of the SmPC indicates that the strength of the active ingredient is 150 mg), therefore, the following
approach must be adopted:
"Full Presentation Name" (AP.13.1) = Triamcinolone acetonide 40 Compresse rivestite
"Product Short Name" (AP.13.2) = <this field should be left blank>

"Product INN/Common Name" (AP.13.3) = Triamcinolone acetonide 40

"Product Company Name" (AP.13.4) = PharmaABC

"Product Strength Name" (AP.13.5) = <this field should be left blank>

EXAMPLE 27

The SmPC of a medicinal product authorised in the Germany states the following information:
1. BEZEICHNUNG DES ARZNEIMITTELS
Insulin PharmaX Comb 30/70 100 I.E./ml Zylinderampullen mit Injektionssuspension

"Full Presentation Name" (AP.13.1) = Insulin PharmaX Comb 30/70 100 I.E./ml Zylinderampullen mit
Injektionssuspension

"Product Short Name" (AP.13.2) = <this field should be left blank>

"Product INN/Common Name" (AP.13.3) = Insulin 30/70 Comb

"Product Company Name" (AP.13.4) = Pharma X

"Product Strength Name" (AP.13.5) = 100 I.E./ml

EXAMPLE 28

The SmPC of a medicinal product authorised in Austria states the following information:

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1. BEZEICHNUNG DES ARZNEIMITTELS
DrugLV Filmtabletten

"Full Presentation Name" (AP.13.1) = DrugLV Filmtabletten

"Product Short Name" (AP.13.2) = DrugLV

"Product INN/Common Name" (AP.13.3) = <this field should be left blank>

"Product Company Name" (AP.13.4) = <this field should be left blank>

"Product Strength Name" (AP.13.5) = <this field should be left blank>

EXAMPLE 29

The SmPC of a medicinal product authorised in Germany states the following information:

1. BEZEICHNUNG DES ARZNEIMITTELS

DrugVero 200 tablet Migraine, omhulde tablet

The number "200" does not refer to the strength (as section 2. Qualitative and Quantitative
composition of the SmPC indicates that the strength of the active ingredient is 150 mg), therefore, the
following approach has to be adopted:

"Full Presentation Name" (AP.13.1) = DrugVero 200 tablet Migraine, omhulde tablet

"Product Short Name" (AP.13.2) = DrugVero 200 Migraine

"Product INN/Common Name" (AP.13.3) = <this field should be left blank>

"Product Company Name" (AP.13.4) = <this field should be left blank>

"Product Strength Name" (AP.13.5) = <this field should be left blank>

"Product Form Name" (AP.13.6) = omhulde tablet

1.2.13.6. Product Form Name (AP.13.6)

If included in the medicinal product name stated in Section 1. Name of the medicinal
product of the SmPC, the pharmaceutical form name part of the medicinal product name
without any other designations must be specified.

If the pharmaceutical form is not included in the medicinal product name stated in Section 1. Name of
the medicinal product of the SmPC, then the field "Product Form Name" (AP.13.6) must be left blank –
see EXAMPLE 31.

EXAMPLE 30

The SmPC of a medicinal product authorised in Italy states the following information:
1. DENOMINAZIONE DEL MEDICINALE

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XYZ® (triamcinolone acetonide) 40 mg Compresse rivestite

"Full Presentation Name" (AP.13.1) = XYZ® (triamcinolone acetonide) 40 mg Compresse rivestite

"Product Short Name" (AP.13.2) = XYZ
"Product INN/Common Name" (AP.13.3) = triamcinolone acetonide
"Product Company Name" (AP.13.4) = <this field should be left blank>
"Product Strength Name" (AP.13.5) = 40 mg
"Product Form Name" (AP.13.6) = Compresse rivestite

EXAMPLE 31

The SmPC of a medicinal product authorised in Malta states the following information:
1. Name of the medicinal product
ProductXYZ® 100mg lemon-flavour lozenges
(Pantoprazole)

"Full Presentation Name" (AP.13.1) = ProductXYZ® 100 mg lemon-flavour lozenges Pantoprazole

"Product Short Name" (AP.13.2) = ProductXYZ lemon-flavour

"Product INN/Common Name" (AP.13.3) = Pantoprazole

"Product Company Name" (AP.13.4) = <this field should be left blank>

"Product Strength Name" (AP.13.5) = 100mg

"Product Form Name" (AP.13.6) = lozenges

EXAMPLE 32

The SmPC of a medicinal product authorised in Germany states the following information:
1. BEZEICHNUNG DES ARZNEIMITTELS
ProduktG PharmaS 10 mg

"Full Presentation Name" (AP.13.1) = ProduktG PharmaS 10 mg

"Product Short Name" (AP.13.2) = ProduktG

"Product INN/Common Name" (AP.13.3) = <this field should be left blank>

"Product Company Name" (AP.13.4) = PharmaS

"Product Strength Name" (AP.13.5) = 10 mg

"Product Form Name" (AP.13.6) = <this field should be left blank>

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EXAMPLE 33 - Presentation name elements – vaccines

The SmPC of a medicinal product with a valid MA in Northern Ireland states the following information:
1. Name of the medicinal product
VACCXYZ 10 microgram/strain suspension for injection; Influenza vaccine (split virion, inactivated)

"Full Presentation Name" field (AP.13.1) = VACCXYZ 10 microgram/strain suspension for injection;
Influenza vaccine (split virion, inactivated)
"Product Short Name" field (AP.13.2) = VACCXZ
"Product INN/Common Name" field (AP.13.3) = Influenza vaccine (split virion, inactivated)
"Product Company Name" field (AP.13.4) = <this field should be left blank>
"Product Strength Name" field (AP.13.5) = 10 microgram/strain
"Product Form Name" field (AP.13.6) = suspension for injection

EXAMPLE 34 - Presentation name elements – vaccines

The SmPC of a medicinal product authorised in Ireland states the following information:
1. Name of the medicinal product
ProductX suspension and emulsion for emulsion for injection
Influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)

"Full Presentation Name" field (AP.13.1) = ProductX suspension and emulsion for emulsion for
injection Influenza vaccine (H1N1) (split virion,
inactivated, adjuvanted)
"Product Short Name" field (AP.13.2) = ProductX
"Product INN/Common Name" field (AP.13.3) = Influenza vaccine (H1N1) (split virion, inactivated,
adjuvanted)
"Product Company Name" field (AP.13.4) = <this field should be left blank>
"Product Strength Name" field (AP.13.5) = <this field should be left blank>
"Product Form Name" field (AP.13.6) = suspension and emulsion for emulsion for injection

EXAMPLE 35 - Presentation name elements – vaccines

The SmPC of a medicinal product authorised In Ireland states the following information:
1. Name of the medicinal product
DrugABC 2013/2014 suspension for injection (influenza vaccine, surface antigen, inactivated)

"Full Presentation Name" field (AP.13.1) = DrugABC 2013/2014 suspension for injection (influenza
vaccine, surface antigen, inactivated)
"Product Short Name" field (AP.13.2) = DrugABC
"Product INN/Common Name" field (AP.13.3) = influenza vaccine, surface antigen, inactivated

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"Product Company Name" field (AP.13.4) = <this field should be left blank>
"Product Strength Name" field (AP.13.5) = 2013/2014
"Product Form Name" field (AP.13.6) = suspension for injection

EXAMPLE 36 - Presentation name elements – vaccines

The SmPC of a medicinal product authorised In Ireland states the following information:
1. Name of the medicinal product
DrugABC 2013/2014 10 microgram/strain suspension for injection
(influenza vaccine, surface antigen, inactivated)

"Full Presentation Name" field (AP.13.1) = DrugABC 2013/2014 10 microgram/strain suspension

for injection (influenza vaccine, surface antigen,
inactivated)
"Product Short Name" field (AP.13.2) = DrugABC
"Product INN/Common Name" field (AP.13.3) = influenza vaccine, surface antigen, inactivated
"Product Company Name" field (AP.13.4) = <this field should be left blank>
"Product Strength Name" field (AP.13.5) = 10 microgram/strain
"Product Form Name" field (AP.13.6) = suspension for injection

1.2.14. Authorised pharmaceutical form (AP.APF.1)

The authorised pharmaceutical form(s) must be specified in consistency with the

information stated in section 3. Pharmaceutical Form of the SmPC.

"Authorised pharmaceutical form" can be defined as the pharmaceutical form of the product as it is
authorised and, where applicable, before transformation into the administrable pharmaceutical form.

The pharmaceutical form stated in section 3. Pharmaceutical Form of the SmPC may differ from the
standard term included in the EDQM standard term list. In such cases, the EV Code of an EDQM
standard term available in the XEVMPD must be selected. I.e., it is not necessary to request the
addition of a new proposed term for the pharmaceutical form name stated in section 3. Pharmaceutical
Form of the SmPC in the XEVMPD – see EXAMPLE 37, scenario 1.

• If a not-nullified standard term of the required pharmaceutical form is available, MAHs should
reference the EV Code of the standard term in their pharmaceutical product entity within their
AMP.

• If a not-nullified standard term is NOT available, and a not-nullified proposed term of the
required pharmaceutical form is available, MAHs should reference the EV Code of the proposed
term in their pharmaceutical product entity within their AMP.

• If the required pharmaceutical form is not available as a standard or a proposed term in the
XEVMPD and:

− the term is flagged as "Pending" on the EDQM website; or

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 − an application for a new pharmaceutical form was/will be submitted to the maintenance
organisation (i.e., EDQM) via the NCA or EMA (as applicable) with the request for adding it to
the standard term list; and

− the requested pharmaceutical form is not included in the list of proposed pharmaceutical
forms re-mapped to standard pharmaceutical forms in the pharmaceutical form mapping
list named 'D1 - XEVMPD-RMS_EDQM Pharmaceutical Dose Form terms mapping' and
available in the 'Documents' section of the Referentials Management Service (RMS) portal,

then the pharmaceutical form must be provided as a new proposed term in the XEVMPD by the
EMA.

From 18 January 2024, only the EMA can enter and maintain proposed and/or standard terms in
the XEVMPD.

See section 1.8. Initial submission of an authorised/administrable pharmaceutical form of this

document for further information on how to request the addition of a proposed pharmaceutical
form in the XEVMPD.

EV Code(s) of the available pharmaceutical dose form terms in the XEVMPD can be found in:

• the 'Pharmaceutical Forms' look-up table in EVWEB; or

• the 'Mappings' section of the pharmaceutical form term in the Referentials Management System
(RMS).

• An 'XEVMPD pharmaceutical dose forms' list is also published on the 'Guidance documents related
to data submission for authorised medicines' webpage. However, this published list is not
maintained since February 2023 and therefore does not contain the most up to date information.

NOTE 7

In cases where multiple distinct pharmaceutical forms are referenced in section 3. Pharmaceutical
Form of the SmPC, the authorised pharmaceutical form term must be provided for each distinct
pharmaceutical form (i.e., repeat the authorised pharmaceutical form data element):

EXAMPLE 37

Scenario 1
Section 3. PHARMACEUTICAL FORM of the SmPC states:
Hard capsule.
Cream.
Therefore, two authorised pharmaceutical forms must be specified. Moreover, since "Hard capsule" is
not a standard EDQM term, the AMP should reference the standard term "Capsule, hard" instead:
- Capsule, hard (PHF00006MIG)
- Cream (PHF00017MIG)

Scenario 2

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Section 3. PHARMACEUTICAL FORM of the SmPC states:
Tablet and gel

Therefore, two Authorised pharmaceutical forms must be specified:

- Tablet (PHF00245MIG)
- Gel (PHF00095MIG)

NOTE 8

Where the medicinal product contains an authorised pharmaceutical form to be reconstituted or diluted
prior to administration, the authorised pharmaceutical form should be specified as a single value and
as it is described in section 3. Pharmaceutical form of the SmPC.

− E.g., "Powder for solution for injection" is the authorised pharmaceutical form, for which the
administrable pharmaceutical form is "Solution for injection".

Where the medicinal product contains an authorised pharmaceutical form for which no reconstitution,
dilution or transformation is necessary prior administration, the authorised pharmaceutical form should
be specified as a single value and as it is described in section 3. Pharmaceutical form of the SmPC.

− E.g., "Film-coated tablet" is the authorised pharmaceutical form, for which the administrable
pharmaceutical form is "Film-coated tablet".

1.2.15. Package description (AP.13.7)

A brief package description of the pack size(s) corresponding to the referenced

authorisation number as indicated in section 6.5 Nature and contents of container of the
SmPC must be specified in the language of the SmPC. An English text is also acceptable.

The package description is a textual representation mainly in relation to the pack size(s).

Only one package description may be provided in this field:

• For centrally authorised products, each package presentation is authorised with an individual
authorisation number. Therefore, individual AMP entities must be submitted for each pack size –
see EXAMPLE 6.

• For non-centrally authorised products, one authorisation number can be applicable for several
pack sizes, or each pack size can be authorised with a unique authorisation number. As explained
in section 1.1 Initial submission of an authorised medicinal product (AMP) entity, products under
the ULCM, where the same authorisation number covers several pack sizes, should be submitted in
the XEVMPD at the level of the pack size. MAHs should therefore submit multiple authorised
medicinal product entities for such medicinal products in the XEVMPD; each AMP entry should
reference the individual pack size in the "Package description" field (AP.13.7) – see Option 2 of
EXAMPLE 2.

Before the requirement to submit individual AMP entries for specific pack sizes for products under the
ULCM was in place, the package description was considered a field to include information as stated in
section 6.5 of the SmPC. E.g.:

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EXAMPLES of package description as requested before 2024:
84 or 100 tablets in an amber glass bottle.
48 or 96 tablets in an aluminium blister pack.
Packs containing 7, 14, 28, 42, 56, 84 and 98 film-coated tablets.
Pack sizes of 1 and 5 inls of 10 ml or a multipack of 5 packs of 1 x 10 ml inl.
Confezione da 14, 28 or 98 compresse rivestite con film in blister
Velikost balení: 20 tablet
Ampoule en verre neutre de 1 ml. 5 ampoules dans un carton.

With the new requirement in force, this package description field is more important and therefore some
more meaningful information should be provided.
For those products, where the authorisation number is the same for all pack sizes, national IDs should
also be provided in the package description. Other information such as the pack size (quantity and
units of presentation) or the material can be provided either on the national language or in English.
See information on slides 54 and 55 of the Pack Size Submissions: from XEVMPD to PMS presentation
for related information.
For medicinal products authorised in countries with multiple official languages (i.e. Belgium,
Luxemburg and Finland), multiple records should be submitted as per information in Table 1b of this
document. In those cases, the package description should be the same for records that represent the
same package size in different languages. This package description can be provided in English.
This way, records with the same package description will be grouped under the same packaged
medicinal product in PMS.
EXAMPLES of package description as requested from 2024:
34009 496 036 9 5 - 21 comprimé(s) - 1 plaquette(s) thermoformée(s) PVC-Aluminium
706755 - 60 parches - Papel/PET/Al/PAN

EXAMPLES of package description as requested from 2024 for multilingual countries:

PRD1234: PET-Flaschen (Polyethylenterephthalat) von 200 ml
PRD5678: PET-fles van 200 ml met een gegradueerd maatbekertje (5, 10, 15 en 20 ml) en een
veiligheidsdop voor kinderen.
PRD9012: Flacon en PET de 200 ml avec gobelet doseur gradué (5, 10, 15 et 20 ml) et bouchon de
sécurité pour enfants.
All these EV codes should reflect the same package description: 200 ml PET bottle with graduated
measuring cup (5, 10, 15 and 20 ml) and child-resistant cap.

1.2.16. Comment (AP.14)

The text in English "Medicinal product authorised for the treatment in children" must be
stated if an indication for pediatric population (children under the age of 18) is stated in
Section 4.1 Therapeutic indications of the SmPC and/or a posology is stated for any subset
of the pediatric population in Section 4.2. Posology and method of administration of the
SmPC.

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In case of a nullification [i.e., operation type 'Nullification' (4) is used in an XEVPRM] of an authorised
medicinal product entity, the 'Comment' field (AP.14) must be populated with the reason for
nullification (e.g., "Duplicate of PRDXXX). See of this document for further information.

Authorised Medicinal Product entity flagged as "Valid" by the Agency can only be nullified by the
Agency. See section 2.4.7. Nullification of AMP entities of this document for further information.

EXAMPLE 38

Scenario 1
Section 4.1 Therapeutic indications of the SmPC states:
Levetiracetam ProductXYZ is indicated as monotherapy in the treatment of partial onset seizures in
adults and adolescents from 16 years of age with newly diagnosed epilepsy.

Scenario 2
Section 4.2 Posology and method of administration of the SmPC states:
Posology
Monotherapy for adults and adolescents from 16 years of age.
The recommended starting dose is 250 mg twice daily which should be increased to an initial
therapeutic dose of 500 mg twice daily after two weeks.

Therefore, in both cases, the text in English "Medicinal product authorised for the treatment in
children" must be specified in the "Comment" field (AP.14) of the authorised medicinal product entity.

1.2.17. AMP - Pharmaceutical product elements (AP.PPs)

Section 3. Pharmaceutical form and section 2. Qualitative and Quantitative composition of

the SmPC indicate the number and composition of pharmaceutical product(s) within the
medicinal product.

Pharmaceutical product element structure:

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Each Authorised Medicinal Product entity in the XEVMPD must contain at least one pharmaceutical
product. The technical concept of a "pharmaceutical product" refers to the qualitative and quantitative
composition of a medicinal product in the pharmaceutical form approved for administration in line with
the regulated product information.

A medicinal product may contain one or more "pharmaceutical product" (e.g., a kit containing vaginal
tablets 500 mg and a vaginal cream 10% or a kit containing a combination of norethindrone acetate
and ethinyl estradiol tablets and ferrous fumarate tablets). In these instances, a pharmaceutical
product section is to be completed for each "pharmaceutical product" in an XEVPRM – see EXAMPLE 40
and EXAMPLE 41.

Where applicable, the technical concept of a "pharmaceutical product" can also include information on
a medical device if it is an "integral part" of the medicinal product for example the scaffolding or net
for a cell therapy medicinal product in accordance with Regulation (EC) No 1394/2007.

The administrable pharmaceutical form refers to the pharmaceutical form for administration to the
patient, after any necessary transformation of the "manufactured" pharmaceutical form has been
carried out.

EXAMPLE 39

TradenameXYZ® powder and solvent for solution for injection

Authorised pharmaceutical form: powder and solvent for solution for injection

Administrable Pharmaceutical product (after transformation) – administrable pharmaceutical form:

solution for injection

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EXAMPLE 40

The SmPC of a medicinal product authorised In Ireland states the following information:
1. Name of the medicinal product
ProductQ Combi Pessary and Cream

2. Qualitative and Quantitative composition

ProductQ Combi pessary contains Clotrimazole 500mg.
ProductQ Combi cream contains Clotrimazole 2% w/w.
For excipients, see 6.1.

3. Pharmaceutical form
Pessary and Cream

6.1 List of excipients

The pessary contains: Lactose monohydrate, Microcrystalline cellulose;
The cream contains: Benzyl alcohol, Purified Water

An XEVMPD entity should be created by EVWEB users as follows:

XEVMPD entity should be created by Gateway users as follows:

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EMA/135580/2012 Page 72/200
SmPC
XEVPRM Technical Specifications xEVMPD Unit Code/Value
Reference

Section 1 Authorised Product – Presentation

Name element
AP.13 presentationname

AP.13.1 Productname ProductQ Combi Pessary and

Cream
AP.13.2 Productshortname ProductQ Combi
AP.13.3 Productgenericname
AP.13.4 Productcompanyname
AP.13.5 Productstrength
AP.13.6 Productform Pessary and Cream
Authorisation – Medicinal Product
Type elements
AP.12.MPT medicinalproducttype
AP.12.MPT.1 producttypecode 7 (= Other)
Authorised product - Authorised
Pharmaceutical Form elements
AP.APF authpharmform
Section 3. AP.APF.1 authpharmformcode PHF00180MIG [= Pessary ]
Pharma-
ceutical
Form
@ resolutionmode 2
AP.APF..1
Section 3 The Pharmaceutical Product
element
PP pharmaceuticalproduct
PP.1 pharmformcode PHF00180MIG [= Pessary ]
@PP.1..1 (@)resolutionmode 2
Section The Pharmaceutical Product –
4.2 Administration Route element
PP.AR adminroute
PP.AR.1 adminroutecode ADR00067MIG [= vaginal
use]
@ (@)resolutionmode
PP.AR.1..1 2
Section 2 The Pharmaceutical Product –
Active Ingredient element
PP.ACT activeingredient
Section 2 PP.ACT.1 substancecode SUB06777MIG
[=clotrimazole]
@ (@)resolutionmode 2
PP.ACT.1..1
PP.ACT.2 concentrationtypecode 1 [= Equal]

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SmPC
XEVPRM Technical Specifications xEVMPD Unit Code/Value
Reference

PP.ACT.3 lowamountnumervalue 500

PP.ACT.4 lowamountnumerprefix M [= milli (1x10^-3)]
PP.ACT.5 lowamountnumerunit G [= Gram(s)]
PP.ACT.6 lowamountdenomvalue 1
PP.ACT.7 lowamountdenomprefix 1 [= single]
PP.ACT.8 lowamountdenomunit 1{PESSARY} [=Pessary]
Section The Pharmaceutical product –
6.1 Excipient element
PP.EXC excipient
Section PP.EXC.1 substancecode SUB12098MIG [= Lactose
6.1 monohydrate]
@ (@)resolutionmode 2
PP.EXC.1..1
Section PP.EXC.1 substancecode SUB12626MIG
6.1 [=Microcrystalline cellulose]

@ (@)resolutionmode 2
PP.EXC.1..1
Authorised product - Authorised
Pharmaceutical Form elements
AP.APF authpharmform
Section 3. AP.APF.1 authpharmformcode PHF00017MIG [=cream]
Pharma-
ceutical
Form
@ resolutionmode 2
AP.APF..1
Section 3 The Pharmaceutical Product
element
PP pharmaceuticalproduct
PP.1 pharmformcode PHF00017MIG [=cream]
@PP.1..1 (@)resolutionmode 2
Section The Pharmaceutical Product –
4.2 Administration Route element
PP.AR adminroute
PP.AR.1 adminroutecode ADR00003MIG [= cutaneous
use]
@ (@)resolutionmode
PP.AR.1..1 2
Section 2 The Pharmaceutical Product –
Active Ingredient element
PP.ACT activeingredient
Section 2 PP.ACT.1 substancecode SUB06777MIG
[=clotrimazole]

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SmPC
XEVPRM Technical Specifications xEVMPD Unit Code/Value
Reference

@ (@)resolutionmode 2
PP.ACT.1..1
PP.ACT.2 concentrationtypecode 1 [= Equal]
PP.ACT.3 lowamountnumervalue 2
PP.ACT.4 lowamountnumerprefix 1 [= single]
PP.ACT.5 lowamountnumerunit %{W/W} [=Percent
Weight/Weight]
PP.ACT.6 lowamountdenomvalue 1
PP.ACT.7 lowamountdenomprefix 1 [= single]
PP.ACT.8 lowamountdenomunit 1{TUBE} [= Tube]
Section The Pharmaceutical product –
6.1 Excipient element
PP.EXC excipient
Section PP.EXC.1 substancecode SUB057771MIG [= Benzyl
6.1 Alcohol]
@ (@)resolutionmode 2
PP.EXC.1..1
Section PP.EXC.1 substancecode SUB33563 [= Purified Water]
6.1

@ (@)resolutionmode 2
PP.EXC.1..1

EXAMPLE 41

The SmPC of a medicinal product authorised In Ireland states the following information:
1. Name of the medicinal product
TriProduct contraceptive tablets

2. Qualitative and Quantitative composition

White tablets: Ethinylestradiol 0.5 mg; Norethindrone 0.035 mg
Peach tablets: Ethinylestradiol 0.75 mg; Norethindrone 0.035 mg
Pink tablets: Ethinylestradiol 1 mg; Norethindrone 0.035 mg

3. Pharmaceutical form
Tablets (white, peach, pink)

6.1 List of excipients

White tablets: Lactose

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Peach tablet: Pregelatinised starch
Pink tablet: Magnesium stearate

An XEVMPD entity should be created by EVWEB users as follows:

XEVMPD entity should be created by Gateway users as follows:

SmPC XEVMPD Unit

XEVPRM Technical Specifications
Reference Code/Value

Section 1 Elements within the Authorised

Product – Presentation Name element
AP.13 presentationname
AP.13.1 Productname Triproduct contraceptive
tablets
AP.13.2 Productshortname Triproduct
AP.13.3 Productgenericname
AP.13.4 Productcompanyname

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SmPC XEVMPD Unit
XEVPRM Technical Specifications
Reference Code/Value

AP.13.5 Productstrength
AP.13.6 Productform tablets
Authorisation – Medicinal Product
Type elements
AP.12.MPT medicinalproducttype
AP.12.MPT.1 producttypecode 7 (= Other)
Authorised product - Authorised
Pharmaceutical Form elements
AP.APF authpharmform
Section 3. AP.APF.1 authpharmformcode PHF00245MIG [= tablet]
Pharma-
ceutical
Form
@ resolutionmode 2
AP.APF..1
Section 3 The Pharmaceutical Product element
PP pharmaceuticalproduct
PP.1 pharmformcode PHF00245MIG [= tablet]
@PP.1..1 (@)resolutionmode 2
Section 4.2 The Pharmaceutical Product –
Administration Route element
PP.AR adminroute
PP.AR.1 adminroutecode ADR00048MIG [= oral use]
@ (@)resolutionmode
PP.AR.1..1 2
Section 2 The Pharmaceutical Product – Active
Ingredient element
PP.ACT activeingredient
Section 2 PP.ACT.1 substancecode SUB07277MIG [=
Ethinylestradiol ]
@ (@)resolutionmode
PP.ACT.1..1 2
PP.ACT.2 concentrationtypecode 1 [= Equal]
PP.ACT.3 lowamountnumervalue 0.5
PP.ACT.4 lowamountnumerprefix M [= milli (1x10^-3)]
PP.ACT.5 lowamountnumerunit G [= Gram(s)]
PP.ACT.6 lowamountdenomvalue 1
PP.ACT.7 lowamountdenomprefix 1 [= single]
PP.ACT.8 lowamountdenomunit 1{TABLET} [= Tablet]
Section 2 PP.ACT.1 substancecode SUB09362MIG [=
Norethindrone]
@ (@)resolutionmode
PP.ACT.1..1 2

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SmPC XEVMPD Unit
XEVPRM Technical Specifications
Reference Code/Value

PP.ACT.2 concentrationtypecode 1 [= Equal]

PP.ACT.3 lowamountnumervalue 0.035
PP.ACT.4 lowamountnumerprefix M [= milli (1x10^-3)]
PP.ACT.5 lowamountnumerunit G [= Gram(s)]
PP.ACT.6 lowamountdenomvalue 1
PP.ACT.7 lowamountdenomprefix 1 [= single]
PP.ACT.8 lowamountdenomunit 1{TABLET} [= Tablet]
Section 6.1 The Pharmaceutical product –
Excipient element
PP.EXC excipient
Section 6.1 PP.EXC.1 substancecode SUB14317MIG [= Lactose]
@ (@)resolutionmode 2
PP.EXC.1..1
Section 3 The Pharmaceutical Product element
PP pharmaceuticalproduct
PP.1 pharmformcode PHF00245MIG [= tablet]
@PP.1..1 (@)resolutionmode 2
Section 4.2 The Pharmaceutical Product –
Administration Route element
PP.AR adminroute
PP.AR.1 adminroutecode ADR00048MIG [= oral use]
@ (@)resolutionmode
PP.AR.1..1 2
Section 2 The Pharmaceutical Product – Active
Ingredient element
PP.ACT activeingredient
Section 2 PP.ACT.1 substancecode SUB07277MIG
[=Ethinylestradiol]
@ (@)resolutionmode 2
PP.ACT.1..1
PP.ACT.2 concentrationtypecode 1 [= Equal]
PP.ACT.3 lowamountnumervalue 0.75
PP.ACT.4 lowamountnumerprefix M [= milli (1x10^-3)]
PP.ACT.5 lowamountnumerunit G [= Gram(s)]
PP.ACT.6 lowamountdenomvalue 1
PP.ACT.7 lowamountdenomprefix 1 [= single]
PP.ACT.8 lowamountdenomunit 1{TABLET} [= Tablet]
Section 2 PP.ACT.1 substancecode SUB09362MIG [=
Norethindrone]
@ (@)resolutionmode
PP.ACT.1..1 2
PP.ACT.2 concentrationtypecode 1 [= Equal]

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SmPC XEVMPD Unit
XEVPRM Technical Specifications
Reference Code/Value

PP.ACT.3 lowamountnumervalue 0.035

PP.ACT.4 lowamountnumerprefix M [= milli (1x10^-3)]
PP.ACT.5 lowamountnumerunit G [= Gram(s)]
PP.ACT.6 lowamountdenomvalue 1
PP.ACT.7 lowamountdenomprefix 1 [= single]
PP.ACT.8 lowamountdenomunit 1{TABLET} [= Tablet]
Section 6.1 The Pharmaceutical product –
Excipient element
PP.EXC excipient
Section 6.1 PP.EXC.1 substancecode SUB37204MIG [=
Pregelatinised starch]
@ (@)resolutionmode 2
PP.EXC.1..1
Section 3 The Pharmaceutical Product element
PP pharmaceuticalproduct
PP.1 pharmformcode PHF00245MIG [= tablet]
@PP.1..1 (@)resolutionmode 2
Section 4.2 The Pharmaceutical Product –
Administration Route element
PP.AR adminroute
PP.AR.1 adminroutecode ADR00048MIG [= oral use]
@ (@)resolutionmode
PP.AR.1..1 2
Section 2 The Pharmaceutical Product – Active
Ingredient element
PP.ACT activeingredient
Section 2 PP.ACT.1 substancecode SUB07277MIG [=
Ethinylestradiol]
@ (@)resolutionmode 2
PP.ACT.1..1
PP.ACT.2 concentrationtypecode 1 [= Equal]
PP.ACT.3 lowamountnumervalue 0.75
PP.ACT.4 lowamountnumerprefix M [= milli (1x10^-3)]
PP.ACT.5 lowamountnumerunit G [= Gram(s)]
PP.ACT.6 lowamountdenomvalue 1
PP.ACT.7 lowamountdenomprefix 1 [= single]
PP.ACT.8 lowamountdenomunit 1{TABLET} [= Tablet]
PP.ACT.14 highamountdenomunit
Section 2 PP.ACT.1 substancecode SUB09362MIG [=
Norethindrone]
@ (@)resolutionmode
PP.ACT.1..1 2

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SmPC XEVMPD Unit
XEVPRM Technical Specifications
Reference Code/Value

PP.ACT.2 concentrationtypecode 1 [= Equal]

PP.ACT.3 lowamountnumervalue 0.035
PP.ACT.4 lowamountnumerprefix M [= milli (1x10^-3)]
PP.ACT.5 lowamountnumerunit G [= Gram(s)]
PP.ACT.6 lowamountdenomvalue 1
PP.ACT.7 lowamountdenomprefix 1 [= single]
PP.ACT.8 lowamountdenomunit 1{TABLET} [= Tablet]
Section 6.1 The Pharmaceutical product –
Excipient element
PP.EXC excipient
Section 6.1 PP.EXC.1 substancecode SUB12527MIG [=
Magnesium stearate]
@ (@)resolutionmode 2
PP.EXC.1..1

1.2.17.1. Administrable pharmaceutical form (PP.1)

The administrable pharmaceutical form(s) must be specified in consistency with information

in Section 3. Pharmaceutical form of the SmPC.

The pharmaceutical form stated in section 3. Pharmaceutical Form of the SmPC may differ from the
standard term included in the EDQM standard term list. In such cases, the EDQM standard term
available in the XEVMPD must be selected. I.e., it is not necessary to request the addition of a new
proposed term for the pharmaceutical form stated in section 3. Pharmaceutical Form of the SmPC in
the XEVMPD – see EXAMPLE 37, scenario 1.

The "Administrable pharmaceutical form" refers to the pharmaceutical form for administration to the
patient, after any necessary transformation of the authorised pharmaceutical form has been carried
out.

EXAMPLES of administrable pharmaceutical forms identical to the authorised pharmaceutical forms:

solution for injection, tablet, capsule, inhalation powder.

The administrable pharmaceutical form is identical to the authorised pharmaceutical form in cases
where no transformation is necessary prior administration to the patient.

• If a not-nullified standard term of the required pharmaceutical form is available, MAHs should
reference the EV code of the standard term in their pharmaceutical product entity within their AMP.

• If a not-nullified standard term is NOT available, and a not-nullified proposed term of the
required pharmaceutical form is available, MAHs should reference the EV Code of the proposed
term in their pharmaceutical product entity within their AMP.

• If the required pharmaceutical form is not available as a standard or a proposed term in the
XEVMPD and:

− the term is flagged as "Pending" on the EDQM website; or

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 − an application for a new pharmaceutical form was/will be submitted to the maintenance
organisation (i.e., EDQM) via the NCA or EMA (as applicable) with the request for adding it to
the standard term list; and

− the requested pharmaceutical form is not included in the list of proposed pharmaceutical
forms re-mapped to standard pharmaceutical forms named 'D1 - XEVMPD-RMS_EDQM
Pharmaceutical Dose Form terms mapping' and available in the pharmaceutical form
mapping list available in the 'Documents' section of the Referentials Management Service
(RMS) portal,

then the pharmaceutical form must be provided as a new proposed term in the XEVMPD by the
EMA.

From 18 January 2024, only the EMA can enter and maintain proposed and/or standard terms in
the XEVMPD.

See section 1.8. Initial submission of an authorised/administrable pharmaceutical form of this

document for further information on how to request the addition of a proposed pharmaceutical
form in the XEVMPD.

To find the EV Code(s) of the available pharmaceutical dose form terms in the XEVMPD, MAH users
should check:

• the 'Pharmaceutical Forms' look-up table in EVWEB; or

• the 'Mappings' section of the pharmaceutical form term in the Referentials Management System
(RMS).

• An 'XEVMPD pharmaceutical dose forms' list is also published on the 'Guidance documents related
to data submission for authorised medicines' webpage. However, this published list is not
maintained since February 2023 and therefore does not contain the most up to date information.

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Process map 1 – Referencing a pharmaceutical form in a pharmaceutical product section of
an AMP

A pharmaceutical form (PhF) must be

referenced in an AMP entity in the
XEVMPD

No

2.
Is a not-nullified standard 2.1 Reference the standard
term of the required PhF Yes term of the required PhF in
available in the XEVMPD? your AMP entity

No

3.
Is a not-nullified proposed 3.1 Reference the proposed
term of the required PhF Yes term of the required PhF in
available in the XEVMPD? your AMP entity

No

No 4.1 Reference the standard

4.
term, to which the PhF was
Can the PhF be re-mapped to Yes
remapped to, in your AMP
another standard term?
entity

No

5.1
5. The term should be inserted in Is the term, or any other 5.2 Submit a New term change
Is the term flagged as pending Yes the XEVMPD as a proposed appropriate alternative term No request via RMS to request the insert
on the EDQM website ? term by the EMA name, available in RMS? of the term in RMS and in the XEVMPD

No
Yes

5.3 RMS data stewards will assess

5.1.1.Submit an Update term
your request and provide you with the
6. change request via RMS to request
EV Code/term name of the term to be
Was an application submitted the insert of the term in the XEVMPD
Yes referenced in your AMP
to EDQM to add the term to the
standard term list?

5.4 Reference the term in your AMP

entity
No

Continue
with step
5.1

1.2.17.2. Administration route (PP.AR.1)

The route of administration of the pharmaceutical form must be specified in consistency

with information in Section 4.2. Posology and method of administration of the SmPC.

Administration route section describes the route(s) of administration i.e., the path by which the
medicinal product (described as technical concept of a "pharmaceutical product") is taken into or
makes contact with the body.

The route of administration stated in section 4.2. Posology and method of administration of the SmPC
may differ from the standard term included in the EDQM standard term list. In such cases, the EDQM
standard term available in the XEVMPD must be selected. I.e., it is not necessary to request the

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addition of a new proposed term for the route of administration stated in section 4.2 of the SmPC in
the XEVMPD – see the below example.

EXAMPLES of routes of administration: oral use, intravenous use, ocular use

Section 4.2. Posology and method of administration of the SmPC. of the SmPC states:

Method of administration

This product should be taken orally and should be swallowed whole with liquids. It can be taken with or
without food.

Since "orally" is not a standard EDQM term, the AMP should reference the standard term "Oral use"
instead:

- Oral use (ADR00048MIG)

MAHs may reference deprecated routes of administration in authorised medicinal products to facilitate
the Article 57(2) electronic submission of information on medicines.

• If a not-nullified standard term of the required route of administration is available, MAHs should
reference the EV code of the standard term in their pharmaceutical product entity within their AMP.

• If a not-nullified standard term is NOT available, and a not-nullified proposed term of the
required route of administration is available, MAHs should reference the EV Code of the proposed
term in their pharmaceutical product entity within their AMP.

• If the route of administration is not available as a standard or a proposed term in the

XEVMPD and:

− the term is flagged as "Pending" on the EDQM website; or

− an application for a new route of administration was/will be submitted to the maintenance

Organisation (i.e., EDQM) via the NCA or EMA (as applicable) with the request for adding it to
the standard term list; and

− the requested route of administration is not included in the list of proposed routes of
administration re-mapped to standard routes of administration in the route of
administration mapping list named “D2 - XEVMPD-RMS_EDQM Route of Administration
terms mapping” and available in the document section of the Referentials Management
Service (RMS) portal, then

the route of administration should be provided as a new proposed term in the XEVPRM by the
EMA.

From 18 January 2024, only the EMA can enter proposed and/or standard terms in the XEVMPD.

See section 1.9. Initial Submission of a route of administration (RoA) of this document for further
information on how to submit a RoA in the XEVMPD.

To find the EV Code(s) of the available route of administration terms in the XEVMPD, MAH users should
check:

• the 'Routes of Administration' remote look-up table in EVWEB; or

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• the 'Mappings' section of the route of administration term in the Referentials Management System
(RMS).

• An "eXtended Eudravigilance Product Dictionary (XEVMPD) routes of administration" list is also

published on the 'Guidance documents related to data submission for authorised medicines'
webpage. However, this published list is not maintained since February 2023 and therefore does
not contain the most up to date information.

Process map 2 – Referencing a route of administration in a pharmaceutical product section

of an AMP

A route of administration (RoA) must

be referenced in an AMP entity in the
XEVMPD

No

2.
Is a not-nullified standard 2.1 Reference the standard
term of the required RoA Yes term of the required RoA in
available in the XEVMPD? your AMP entity

No

3.
Is a not-nullified proposed 3.1 Reference the proposed
term of the required RoA Yes term of the required RoA in
available in the XEVMPD? your AMP entity

No

No 4.1 Reference the standard

4. term, to which the RoA was
Yes
Can the RoA be re-mapped to remapped to, in your AMP
another standard term? entity

No

5. 5.1
Is the term flagged as pending The term should be inserted in Is the term, or any other 5.2 Submit a New term change
on the EDQM website or an Yes the XEVMPD as a proposed appropriate alternative term No request via RMS to request the insert
application was/will be term by the EMA name, available in RMS? of the term in RMS and in the XEVMPD
submitted to EDQM??

No
Yes

5.3 RMS data stewards will assess

5.1.1.Submit an Update term
6. your request and provide you with the
change request via RMS to request
Was an application submitted EV Code/term name of the term to be
the insert of the term in the XEVMPD
to EDQM to add the term to the Yes referenced in your AMP
standard
term list?

5.4 Reference the term in your AMP

entity
No

Continue
with step
5.1

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1.2.17.3. Pharmaceutical product drug ingredients and medical device(s)

Section 2. Qualitative and Quantitative composition of the SmPC and section 6.1. List of
excipients of the SmPC indicate the composition of pharmaceutical product(s) within the
medicinal product.

Each pharmaceutical product must contain information on:

• Active ingredient(s) - active ingredient substance name(s) and its/their concentration(s) can be
found in section 2. Qualitative and Quantitative Composition of the corresponding SmPC;

• Excipient(s) - excipient substance name(s) can be found in section 6.1 List of excipients of the
corresponding SmPC. It is optional to submit the concentration(s) of excipient(s);

• In some instances, pharmaceutical product can also contain adjuvants. Adjuvant substance
name(s) and its/their concentration(s) can be found in section 2. Qualitative and Quantitative
Composition of the corresponding SmPC.

Pharmaceutical Product active ingredient element structure:

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Pharmaceutical Product excipient element structure:

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Pharmaceutical Product adjuvant element structure:

Pharmaceutical Product medical device element structure

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NOTE 9

Only approved substances can be referenced in a pharmaceutical product within an authorised

medicinal product entity.

Each approved substance successfully submitted in the XEVMPD has an assigned EV Code. The
preferred name of the approved substance is entered in English. Each translation and synonym are
linked to the master substance EV Code.

The substance name used in the pharmaceutical product must be in line with the substance name used
in the SmPC attached supporting document and should provide the description of the substance within
the medicinal product irrespective of national naming convention or any symbols, commas, and
additional brackets, hyphens. In cases where the substance name referenced in the SmPC differs from
the substance name referenced in the product entity in the XEVMPD, and the MAH references in the
AMP entry the substance name as it is stated in the Module 3 dossier, then an extract from the
Module 3 dossier showing the list of substances within the pharmaceutical product must be provided
as an attachment. The substance information [all substance names and concentration of the active
substance(s)] referenced in the AMP entry should then correspond to the information stated in the
dossier and not in the SmPC. This is to support the validation of the product entry and/or product
entries within the same cluster without the need to raise a follow-up communication (FUP) with the
MAH.

• If a substance name was previously successfully submitted in the XEVMPD and a substance EV
Code has been assigned, the substance name can be selected from the available XEVMPD remote
look-up table in EVWEB. Gateway users should populate the 'Active ingredient substance code' field
(PP.ACT.1) with the assigned substance EV Code.

A list of approved substances available in the XEVMPD, with their assigned EV Codes, can be found
in:

- the 'Approved Substances' remote look-up table in EVWEB;

- the substance export lists published in the Substance Management System (SMS) portal.

- An "eXtended Eudravigilance Product Dictionary (XEVMPD) substances" list look up list is

also published on the 'Guidance documents related to data submission for authorised
medicines' webpage. However, this published list is not maintained since February 2023
and therefore does not contain the most up to date information.

The XEVMPD remote look-up table in EVWEB contains the most up-to-date data, as substance
information is submitted to the XEVMPD on daily basis.

If a new approved substance/substance translation or a synonym/alias needs to be submitted in the

XEVMPD, the process described in section 1.4. Initial submission of an approved substance of this
document should be followed.

EXAMPLE 42

Scenario 1 – Exact substance name is not available in the XEVMPD remote look-up table/published
Controlled Vocabulary (CV) list, but a similar substance name is listed.

Section 6.1. List of excipients of an English SmPC states "IRON OXIDE BROWN (E-172)". The
substance name as stated in the SmPC is not present in the XEVMPD look-up table/published

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Controlled Vocabulary (CV) list. However, an approved substance with a preferred name "IRON OXIDE
BROWN (E172)" is available with EV Code SUB130375 and should therefore be referenced in the
pharmaceutical product. A request for addition of "IRON OXIDE BROWN (E-172)" as a synonym to
SUB130375 should be submitted to the Agency as a request submitted via the EMA Service Desk
portal. The Agency will process the request in the XEVMPD and provide the MAH with the master
substance EV Code to be referenced in their product entry.

Section 2. Qualitative and Quantitative Composition of an English SmPC states "VORTIOXETINE D,L-
LACTATE". The substance name as stated in the SmPC is not present in the XEVMPD look-up
table/published Controlled Vocabulary (CV) list. However, an approved substance with a preferred
name "VORTIOXETINE (D,L)-LACTATE" is available with EV Code SUB130400 and should therefore be
referenced in the pharmaceutical product. A request for addition of "VORTIOXETINE D,L-LACTATE" as a
synonym to SUB130400 should be submitted to the Agency as a request submitted via the EMA
Service Desk portal. The Agency will process the request in the XEVMPD and provide the MAH with the
master substance EV Code to be referenced in their product entry.

Scenario 2 – Substance name is not available in the XEVMPD look-up table/published Controlled
Vocabulary (CV) list.

Section 6.1. List of excipients of a Czech SmPC states "Sepifilm 3011 oranžová", which is a translation
of substance name "Sepifilm 3011 Orange". Neither the substance name as stated in the SmPC nor the
preferred name in English is present in the XEVMPD look-up table/published Controlled Vocabulary
(CV) list. A request for addition of a new preferred substance name and a translation should be
submitted to the Agency as a request submitted via the EMA Service Desk portal. The Agency will
process the request in the XEVMPD and provide the MAH with the master substance EV Code to be
referenced in their product entry.

Section 6.1. List of excipients of a French SmPC states "laque aluminique de rouge cochenille A
(E124)", which is a translation of substance name "aluminium lake red cochenille A (E124)". Neither
the substance name as stated in the SmPC nor the preferred name in English is present in the XEVMPD
look-up table/published Controlled Vocabulary (CV) list. A request for addition of a new preferred
substance name and a translation should be submitted to the Agency as a request submitted via the
EMA Service Desk portal. The Agency will process the request in the XEVMPD and provide the MAH
with the master substance EV Code to be referenced in their product entry.

NOTE 10

If a pharmaceutical product contains no active ingredient, one of the excipients and its strength should
be selected and entered as the active ingredient. The strength of the substance should be referenced
as per the SmPC/Module 3 dossier or, if not included in the SmPC, zero (0) should be referenced as the
amount of the concentration. The substance selected as the active ingredient should not be entered
also as an excipient as this would result in receiving a negative XEVPRM acknowledgement due to
duplication of the same substance within one pharmaceutical product.

When a substance contains multiple components, both, the substance, and the individual components,
should be submitted, providing that the substance has a descriptive level of information relevant to
excipient in medicinal products (e.g., general terms not indicative of excipients in medicines are not
accepted such as thickeners, ink, emulsifiers).

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EXAMPLES:

• Thickeners (methylcellulose, xanthan gum);

Stearate emulsifiers (polyethylene glycol sorbitan tristearate, macrogol stearate, glycerides);

lemon flavour (maltodextrin, arabic gum, lactose, triethyl citrate).

In the authorised product entity, all of the substance names should be referenced separately since they
are substance names referenced in an approved SmPC; i.e., methylcellulose, xanthan gum, stearate
emulsifiers, polyethylene glycol, sorbitan tristearate, macrogol stearate, glycerides, lemon flavour,
maltodextrin, arabic gum, lactose and triethyl citrate.

Further guidance on how to handle approved substance names is included in the 'European Medicines
Agency substance names best practice: Procedure and principles to handle substance name in the
substance management system'' document published in the section "Data Quality-control
methodology" on the 'Guidance documents related to data submission for authorised medicines'
webpage.

1.2.17.4. Active ingredient substance code (PP.ACT.1)

The EV Code(s) of the substance(s) indicated as the active ingredient(s) of the medicinal
product according to the description provided in section 2. Qualitative and Quantitative
Composition of the corresponding SmPC or as indicated in the Module 3 dossier must be
specified.

The substance name must be specified in line with the description of the ingredients present
in the medicinal product as described in the SmPC of the country of authorisation or in the
Module 3 dossier:

• The substance(s) EV Code(s) must be provided.

• For centrally authorised products (CAPs):

− any missing translation names must be provided in all official languages based on the process
described in section 1.4. Initial submission of an approved substance of this document. See
also Table 1a- Authorised medicinal product – language requirements for related information.

• For non-centrally authorised products (MRPs/DCPs/NAPs):

− any missing translation names must be provided in all the applicable national languages based
on the process described in section of this document. See also Table 1a- Authorised medicinal
product – language requirements for related information.

• Any missing synonym/alias names that are in accordance with internationally recognised reference
sources may be requested by means of the process described in section 1.4. Initial submission of
an approved substance of this document.

EXAMPLE 43

The SmPC of a medicinal product authorised in Germany states the following information:
2. QUALITATIVE UND QUANTITATIVE ZUSAMMENSETZUNG

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1 g Creme enthält: 1,67 mg Gentamicinsulfat
The active substance (i.e., EV code of the active substance in the local language) to be referenced in
the pharmaceutical product section of the AMP entity in the XEVMPD must be "Gentamicinsulfat" (in
German language). Since "Gentamicinsulfat" is already available in the XEVMPD look-up
table/published Controlled Vocabulary (CV) list as a translation of SUB02327MIG with the preferred
name "GENTAMICIN SULFATE", this EV Code should be referenced by the MAH in the product entity.

EXAMPLE 44

The SmPC of a medicinal product authorised in Italy states the following information:
2. COMPOSIZIONE QUALITATIVA E QUANTITATIVA
Una compressa rivestita contiene: Principio attivo - Paracetamolo 500 mg
The active substance (i.e., EV code of the active substance in the local language) to be referenced in
the pharmaceutical product section of the AMP entity in the XEVMPD must be "Paracetamolo" (in
Italian language). Since "paracetamolo" is already available in the XEVMPD look-up table/published
Controlled Vocabulary (CV) list as a translation of SUB09611MIG with the preferred name
"paracetamol", this EV Code should be referenced by the MAH in the product entity.

EXAMPLE 45

The SmPC of a medicinal product authorised In Ireland states the following information:
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of metformin hydrochloride corresponding to 18 mg of metformin.
The active substance (i.e., EV Code of the active substance in the local language) to be referenced in
the pharmaceutical product section of the AMP entity in the XEVMPD must be "metformin
hydrochloride". Since "metformin hydrochloride" is already available as the preferred name of
SUB03200MIG, this substance EV Code should be referenced by the MAH in the product entity.

EXAMPLE 46

The SmPC of a medicinal product authorised In Ireland states the following information:
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Olanzapine hydrochloride corresponding to 0.2 mg Olanzapine.
Or
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.2 mg Olanzapine as Olanzapine hydrochloride.
Because the strength is available only for the moiety, the active substance (i.e., EV Code of the
active substance in the local language) to be referenced in the pharmaceutical product section of the
AMP entity in the XEVMPD must be "Olanzapine". Since "Olanzapine" is already available as the
preferred name of SUB09426MIG, this substance EV Code should be referenced by the MAH in the
product entity.

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EXAMPLE 47

The SmPC of a medicinal product authorised In Ireland states the following information:
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of Levetiracetam (as hydrochloride).

Or
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each inl contains Levetiracetam hydrochloride corresponding to 10 mg/ml Levetiracetam after
reconstitution.

The active substance (i.e., EV code of the active substance in the local language) to be referenced in
the pharmaceutical product section of the AMP entity in the XEVMPD must be "Levetiracetam". Since
"Levetiracetam" is already available as the preferred name of SUB08459MIG, this substance EV Code
should be referenced by the MAH in the product entity.

Table 3 - Requirements on how to reflect information on substance and

strength in section 2. Qualitative and Quantitative Composition of the SmPC

Reference
Substance Reference Article 57(2)
Substance Substance Examples
Strength Substance Requirements
Strength

Section 2 of SmPC
states:
  x x Each vial contains
Substance 1000 mg metformin,
+ hydrochloride. After
Substance reconstitution, each
Strength ml of solution
contains 100 mg
metformin,
hydrochloride.

Article 57
requirement:
Substance:
Metformin
hydrochloride
Strength: 100
mg/ml
Section 2 of SmPC
states:
 x   Reference Each capsule
Substance contains 250 mg
+ olanzapine (as
Reference hydrochloride).
Substance Or
Strength Each capsule

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 Reference
Substance Reference Article 57(2)
Substance Substance Examples
Strength Substance Requirements
Strength

contains 250 mg
olanzapine (as
olanzapine
hydrochloride).

Article 57
requirement:
Substance:
Olanzapine
Strength: 250
mg/capsule
Section 2 of SmPC
states:
x x   Reference One mL contains
Substance defibrotide 80mg
+ corresponding to a
Reference quantity of 200 mg
Substance in 2.5 mL in a vial
Strength and equivalent to a
concentration in the
range of 4 mg/mL to
20 mg/mL after
dilution.

Article 57
requirement:
Substance:
Defibrotide
Strength: 4 mg/ml -
20 mg/ml
Section of SmPC
states:
    Each tablet contains
Substance 12 mg loperamide
+ hydrochloride
Substance corresponding to 10
Strength mg loperamide.

Article 57
requirement:
Substance:
Loperamide
hydrochloride
Strength: 12

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 Reference
Substance Reference Article 57(2)
Substance Substance Examples
Strength Substance Requirements
Strength

mg/tablet

1.2.17.5. Active ingredient substance strength

The strength of the substance name specified in the "Active ingredient substance code"
(PP.ACT.1) must be specified in accordance with section 2. Qualitative and Quantitative
Composition of the corresponding SmPC or in the Module 3 dossier.

Whenever possible, the substance strength should be expressed as a unit of measurement.

Strength must be entered in the XEVMPD in accordance with the ISO IDMP standards based on a
numerator and denominator. Strength can be therefore expressed in two ways:

• As a Unit of Measure

When the strength of a medicinal product described as a technical concept of a "Pharmaceutical

Product" that has undergone a transformation (for example reconstitution) is to be specified, it is
to be specified using the strength resulting from transformation undertaken exactly in accordance
with the regulated product information (i.e., in the SmPC as per section 2. Qualitative and
Quantitative Composition).

The use of 'each' as a unit of measure should be limited and only used if it is not possible to
express the strength with a suitable concentration for the unit of presentation. In that case, the
XEVMPD unit value (of measurement) 'each' must be used to describe the strength.

EXAMPLES of units of measure: 10 milligrams per 100 milliliters, 10 milligrams per 1 single day.

• As a Unit a Presentation

The unit of presentation is a qualitative term describing the discrete unit in which a
"pharmaceutical product" is presented to describe strength or quantity in cases where a
quantitative unit of measurement is not appropriate.

EXAMPLES of units of presentation: 250 milligrams per 1 single tablet, 10 milliliters per one single
spoon.

Unit of presentation can be expressed as:

− Strength; e.g., spray/puff contains 100 mcg per actuation (unit of presentation = actuation);

− Quantity; e.g., bottle contains 100 ml per bottle (unit of presentation = bottle).

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NOTE 11

Where an ingredient is present in the form of a salt or hydrate, the quantitative composition may be
expressed in terms of the mass [or biological activity in International (or other) units where
appropriate] of the active moiety (base, acid, or anhydrous material).

The strength declared should be included in the SmPC. No calculations/conversions should be

performed to obtain a figure.

− If the strength is declared as the amount of base, then the base is the substance to be
declared as the ingredient.

− If the strength is declared as the amount of the salt, then the salt is the substance to be
declared as the ingredient.

− In the rare examples where the strength of the salt and the base are both declared, then the
salt is the substance to be declared as the ingredient. This is in line with IDMP where the both
the substance (salt) and the reference substance (base/active moiety) will need to be defined.

EXAMPLE of Reference substance/strength:

"60 mg toremifene (as citrate)" or "toremifene citrate equivalent to 60 mg toremifene" – the substance
'toremifene' will be specified as the active ingredient in the pharmaceutical product.

NOTE 12

Where the active ingredient is an ester or pro-drug, the quantitative composition may be stated in
terms of the quantity of that ester or pro-drug.

Further explanation on the expression of strength is provided in the Notice to Applicants, Volume 2C -
Regulatory Guidelines "Guideline on Summary of Product Characteristics – SmPC.

The active ingredient can be included based on the active substance referenced in the Module 3 dossier
instead of the active substance of the SmPC.

1.2.17.6. Active ingredient concentration type Code (PP.ACT.2)

The ‘Concentration Type Code’ referencing the selected concentration type value must be
specified.

The strength of the substance is to be specified as a quantity of the substance present in a medicinal
product described as the technical concept of a "pharmaceutical product".

The following concentration type values (amount value types) are available for use as part of the
‘EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) concentration types’ list published on
the 'Guidance documents related to data submission for authorised medicines' webpage:

• Equal (1);

• Range (2);

• Up to (3);

• Not less than (4);

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• Approximately (5);

• Average (6).

EXAMPLE 48

The SmPC of a medicinal product authorised In Ireland states the following information:
2. Qualitative and Quantitative Composition
Each tablet contains 10 mg Diazepam
In accordance with the above information stated in the SmPC, the strength of the active ingredient
should be expressed as per unit of presentation. The value should be set to "Equal (1)" and the
strength will be expressed as 10 milligrams per 1 single tablet.

EXAMPLE 49

The SmPC of a medicinal product authorised In Ireland states the following information:
2. Qualitative and Quantitative Composition
Each vial contains 10 mg Paracetamol. After reconstitution, each ml of solution contains approximately
1 mg Paracetamol.
In accordance with the above information stated in the SmPC, the strength of the active ingredient
should be expressed as per unit of measure. The value should be set to "Approximately (5)" and the
strength will be expressed as 1 milligram per 1 millilitre.

EXAMPLE 50

The SmPC of a medicinal product authorised In Ireland states the following information:
2. Qualitative and Quantitative Composition
The concentrate for solution for infusion contains 1000 mg/ml Ibuprofen. After dilution, the
concentration of Ibuprofen will be 100 mg/ml to 200 mg/ml depending on the age of the patient.
In accordance with the above information stated in the SmPC, the strength of the active ingredient
should be expressed as per unit of measure. The value should be set to "Range (2)" and the strength
will be expressed as 100 milligram per 1 millilitre to 200 milligram per 1 millilitre.

1.2.17.7. Active ingredient substance value(s)

A numerator value and numerator unit, as well as a denominator value and denominator
unit, must be specified in accordance with section 2. Qualitative and Quantitative
Composition of the corresponding SmPC or in accordance with the information referenced in
the Module 3 dossier.

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(Low Amount) Numerator Value (PP.ACT.3)

refers to the strength of the active substance expressed in a ratio scale. It refers to the numerator
value of the strength of the active substance.

100 mg/ml: "lowamountnumervalue"= 100

(Low Amount) Numerator Prefix (PP.ACT.4)

refers to the strength of the active substance expressed in a ratio scale. It refers to the numerator unit
prefix value of the strength of the active substance.
100 mg/ml: "lowamountnumerprefix" = Milli (1x10^-3)

(Low Amount) Numerator Unit (PP.ACT.5)

refers to the strength of the active substance expressed in a ratio scale. It refers to the numerator unit
value of the strength of the active substance.
100 mg/ml: "lowamountnumerunit" = Gram(s)

(Low Amount) Denominator Value (PP.ACT.6)

refers to the strength of the active substance expressed in a ratio scale. It refers to the denominator
value of the strength of the active substance.
100 mg/ml: "lowamountdenomvalue" = 1

(Low Amount) Denominator Prefix (PP.ACT.7)

refers to the strength of the active substance expressed in a ratio scale. It refers to the denominator
unit prefix value of the strength of the active substance.
100 mg/ml: "lowamountdenomprefix" = Milli (1x10^-3)

(Low Amount) Denominator Unit (PP.ACT.8)

refers to the strength of the active substance expressed in a ratio scale. It refers to the denominator
unit value of the strength of the active substance.
100 mg/ml: "lowamountdenomunit" = Litre

High Amount Numerator Value (PP.ACT.9)

refers to the strength of the active substance expressed in a ratio scale. It refers to the numerator
value of the strength of the active substance.

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High Amount Numerator Prefix (PP.ACT.10)

refers to the strength of the active substance expressed in a ratio scale. It refers to the numerator
unit prefix value of the strength of the active substance.

High Amount Numerator Unit (PP.ACT.11)

refers to the strength of the active substance expressed in a ratio scale. It refers to the numerator
unit value of the strength of the active substance.

High Amount Denominator Value (PP.ACT.12)

refers to the strength of the active substance expressed in a ratio scale. It refers to the denominator
value of the strength of the active substance.

High Amount Denominator Prefix (PP.ACT.13)

refers to the strength of the active substance expressed in a ratio scale. It refers to the denominator
unit prefix value of the strength of the active substance.

High Amount Denominator Unit (PP.ACT.14)

refers to the strength of the active substance expressed in a ratio scale. It refers to the denominator
unit value of the strength of the active substance.

EXAMPLE 51

Administered dose = 200 mg per capsule

Numerator value: 200

Numerator prefix: milli

Numerator unit: gram(s)

Denominator value: 1

Denominator prefix: single

Denominator unit (of presentation): capsule

EXAMPLE 52

Administered dose = 200 microgram/puff

Numerator value: 200

Numerator prefix: micro

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Numerator unit: gram(s)

Denominator value: 1

Denominator prefix: single

Denominator unit (of presentation): puff

EXAMPLE 53

Administered dose = 0.5 – 2 mg/ml

Low amount numerator value: 0.5

Low amount numerator prefix: milli

Low amount numerator unit: gram(s)

Low amount denominator value: 1

Low amount denominator prefix: milli

Low amount denominator unit (of measurement): litre(s)

High amount numerator value: 2

High amount numerator prefix: milli

High amount numerator unit: gram(s)

High amount denominator value: 1

High amount denominator prefix: milli

High amount denominator unit (of measurement): litre(s)

EXAMPLE 54

Administered dose = 5 mg/1 measuring spoon (if the spoon is provided as part of the package or not
does not have any impact on making reference to the unit of presentation)

Numerator value: 5

Numerator prefix: milli

Numerator unit: gram(s)

Denominator value: 1

Denominator prefix: single

Denominator unit (of presentation): spoon

EXAMPLE 55

1 dose (1 ml) contains Hepatitis A surface antigen 10 micrograms

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Numerator value: 10

Numerator prefix: micro

Numerator unit: gram(s)

Denominator value: 1

Denominator prefix: milli

Denominator unit (of measurement): litre(s)

EXAMPLE 56

1 dose contains Hepatitis B surface antigen 20 micrograms

Numerator value: 20

Numerator prefix: micro

Numerator unit: gram(s)

Denominator value: 1

Denominator prefix: single

Denominator unit (of presentation): dose

EXAMPLE 57

1 ml contains Hepatitis C surface antigen 30 micrograms

Numerator: 30

Numerator prefix: micro

Numerator unit: gram(s)

Denominator value: 1

Denominator prefix: milli

Denominator unit (of measurement): litre(s)

1.2.17.8. Excipient substance code (PP.EXC.1)

The EV Code(s) of the substance(s) indicated as excipient(s) of the medicinal product,

according to the description provided in section 6.1. List of excipients of the corresponding
SmPC, or in the Module 3 dossier, must be specified.

The substance name must be specified in line with the description of the ingredients present
in the medicinal product as described in the SmPC of the country of authorisation:

• The Substance(s) EV Code(s) must be provided.

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• For centrally authorised products (CAPs): any missing translation names must be provided in all
official languages based on the process described in section 1.4. Initial submission of an approved
substance of this document. See also Table 1a- Authorised medicinal product – language
requirements for related information.

• For non-centrally authorised products (MRPs/DCPs/NAPs): any missing translation names must be
provided in all the applicable national languages based on the process described in section 1.4.
Initial submission of an approved substance of this document. See also Table 1a- Authorised
medicinal product – language requirements for related information.

• Any missing synonym/alias names that are in accordance with internationally recognised reference
sources may be requested by means of the process described in section 1.4. Initial submission of
an approved substance of this document.

See also NOTE 9 for related information.

EXAMPLE 58

The SmPC of a medicinal product authorised in Germany states the following information:
6.1 Liste der sonstigen Bestandteile
Wasser für Injektionszwecke
The excipient substance (i.e., an EV code of the excipient substance in the local language) to be
referenced in the pharmaceutical product section of the AMP entity in the XEVMPD must be "Wasser für
Injektionszwecke" (in German language). Since "Wasser für Injektionszwecke" is already available as a
translation of SUB12398MIG, this substance EV Code should be referenced by the MAH in the product
entity.

EXAMPLE 59

The SmPC of a medicinal product authorised in the Czech Republic states the following information:
6.1 Seznam pomocných látek
Granulovaná mikrokrystalická celulosa
Magnesium-stearát
The excipient substances (i.e., EV code of the excipient substances in the local language) to be
referenced in the pharmaceutical product section of the AMP entity in the XEVMPD must be
"Granulovaná mikrokrystalická celulosa" and "Magnesium-stearát" (both in Czech language). Since
"Granulovaná mikrokrystalická celulosa" is already available as a translation of SUB122000, this
substance EV Code should be referenced by the MAH in the product entity.
Since "Magnesium-stearát" is already available as a translation of SUB12527MIG, this substance EV
Code should be referenced by the MAH in the product entity.

1.2.17.9. Excipient substance strength

It is optional to describe the strength(s) of excipient(s). If this information is provided, the

strength(s) of the excipient(s) as listed in section 6.1 List of excipients of the corresponding

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SmPC or as referenced in the Module 3 dossier must be specified in the pharmaceutical
product.

The same principles as described in sections 1.2.17.6. Active ingredient concentration type Code
(PP.ACT.2) and 1.2.17.7. Active ingredient substance value(s) of this document apply to the
description of strength of excipients should the MAH wish to submit it.

1.2.17.10. Adjuvant substance code (PP.ADJ.1)

The EV Code(s) of the substance(s) indicated as adjuvant(s) of the medicinal product

according to the description provided in section 2. Qualitative and Quantitative Composition
(or section 6. List of excipients) of the corresponding SmPC, or as indicated in the Module 3
dossier, must be specified.

The substance name must be specified in line with the description of the ingredients present
in the medicinal product as described in the SmPC of the country of authorisation or in the
Module 3 dossier:

• The substance(s) EV Code(s) must be provided.

• For centrally authorised products (CAPs): any missing translation names must be provided in all
official languages based on the process described in section 1.4. Initial submission of an approved
substance of this document. See also Table 1a- Authorised medicinal product – language
requirements for related information.

• For non-centrally authorised products (MRPs/DCPs/NAPs): any missing translation names must be
provided in all the applicable national languages based on the process described in section 1.4.
Initial submission of an approved substance of this document. See also Table 1a- Authorised
medicinal product – language requirements for related information.

• Any missing synonym/alias names that are in accordance with internationally recognised reference
sources may be requested by means of the process described in section 1.4. Initial submission of
an approved substance of this document.

See also NOTE 9 for related information.

1.2.17.11. Adjuvant substance strength

The strength of the substance stated as the adjuvant of the pharmaceutical product in
section 2. Qualitative and Quantitative Composition of the corresponding SmPC, or in the
Module 3 dossier, must be specified.

Whenever possible, the substance strength should be expressed as a unit of measurement.

The same principles as described in sections 1.2.17.6. Active ingredient concentration type Code
(PP.ACT.2) and 1.2.17.7. Active ingredient substance value(s) of this document apply to the
description of strength of adjuvants.

EXAMPLE 60

The SmPC of a medicinal product authorised In Ireland states the following information:

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hepatitis B surface antigen*…………………………………………………..20 micrograms/ml
*adjuvanted on aluminium hydroxide (0.2 micrograms/ml Al3+)
The adjuvant (i.e., EV code of the adjuvant substance in the local language) to be referenced in the
pharmaceutical product section of the AMP entity in the XEVMPD must be "aluminium hydroxide" (i.e.,
EV Code SUB33625) and the strength is "0.2 micrograms/ml".

1.2.17.12. Medical device Code (PP.MD.1)

The EV code of a medical device where it forms an integral part of the medicinal product
must be specified.

Medical device description is currently only required for Advanced Therapy Medicinal Products (ATMPs),
where applicable (see Regulation (EC) No 1394/2007).
EXAMPLE - medical device: COLLAGEN SCAFFOLD

Where a medical device term is required for an ATMP, the marketing authorisation holder should
submit a request for a term assignment via the EMA Service Desk portal. The Agency will assess the
request and, if the term should be included, provide a code and term name for the medical device to
the marketing authorisation holder.

List of available medical devices with their assigned codes can be found:

• in the 'Medical devices' remote look-up list in EVWEB;

• in the 'EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) medical devices' controlled
vocabulary list published on the 'Guidance documents related to data submission for authorised
medicines' webpage; or

• in the ‘XEVMPD Medical Devices’ list in the Referentials Management System (RMS).

1.2.18. Product ATC Code(s) (AP.ATC.1)

The ATC Code as described in Section 5.1 Pharmacodynamic properties of the SmPC must be
specified.

A "standard" ATC Code must be specified whenever possible.

A list of standard ATC Codes is maintained in the XEVMPD by the Agency.

MAHs should not reference deprecated ATC Codes in authorised medicinal products.

All five levels of the ATC Code can be used.

• Where, for certain types of medicinal products (e.g., authorised, or registered herbal medicinal
products), an ATC Code is usually not allocated the ATC Code value NOTAPPLIC may be specified.

• Where an ATC Code has been requested by the marketing authorisation holder as per the process
explained on the WHO website but has not yet been assigned by the WHO Collaborating Centre for

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 Drug Statistics Methodology, the proposed ATC Code value must be specified even if the SmPC
states "not yet assigned".

• Where an ATC Code has not been requested by the marketing authorisation holder, and the SmPC
states "not yet assigned", the ATC Code value NOTASSIGN must be specified.

• In case that multiple ATC Codes are applicable for one authorised medicinal product, multiple ATC
Codes can be referenced within one AMP entity.

ATC Code information is available:

• on the WHO website;

• in the 'ATC Codes' look-up table in EVWEB; and

• in the 'Anatomical Therapeutic Chemical classification system – Human' list in the Referentials
Management System (RMS). This list will be updated on a yearly basis following WHO’s update
calendar. In addition to the yearly updates, if a specific ATC code is required in RMS for regulatory
purposes, RMS will accept a change request for the publication of codes which have not yet been
published in the final ATC list from WHO if they have been accepted as provisional by WHO.

If the ATC Code for a medicinal product is not part of the ATC Index published by the WHO, and the
ATC Code has been requested by the marketing authorisation holder, the ATC Code should be provided
by the EMA as a "proposed ATC Code" in the XEVMPD via an XEVPRM.

From 18 January 2024, only the EMA can enter proposed and/or standard ATC Codes in the XEVMPD.

See section 1.7. Initial submission of an ATC Code of this document for further information on how to
request the addition of an ATC Code in the XEVMPD.

1.2.19. AMP - Product indications (AP.INDs)

Description of the authorised indication(s) as reflected in Section 4.1 Therapeutic

Indications of the SmPC must be provided in this section.

A copy of MedDRA needs to be obtained from MedDRA.

Further guidance on coding of indications based on section 4.1 of the Summary of Product
Characteristics (SmPC) using MedDRA terminology is available in the document 'Coding of indications
in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)' published on the 'Guidance
documents related to data submission for authorised medicines' webpage.

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1.2.19.1. MedDRA version (AP.IND.1)

The indication(s) is/are to be coded using MedDRA in its latest version, where applicable.

Each indication is to be coded using MedDRA in its latest current version for the operation types "Insert
(1)" and "Update (2)" in the context of the data submission maintenance (e.g., variation, renewal,
etc.). The next official MedDRA version can also be used if a term of that version is required.

EVWEB users may specify one of the following MedDRA versions for the operation types "Invalidate MA
(6)", "Nullification (4)" and "Update (2)" (not in the context of data submission maintenance):

• the latest current version of MedDRA;

• the two previous version of MedDRA;

• the next MedDRA version (for supplemental terms).

EV-POST and Gateway users may specify any MedDRA version after version 7.1 (inclusive) for the
operation types "Invalidate MA (6)", "Nullification (4)" and "Update (2)" (not in the context of data
submission maintenance).

Note that new MedDRA versions are implemented in XEVMPD towards the end of the transition
period defined by MSSO. Therefore, the concept of "latest current version of MedDRA" refers to the
system availability and not to the publishing of a more recent version.

For instance, MedDRA 17.0 was considered the latest current version up to November 2014. Whilst
MedDRA 17.1 was published in September 2014, MedDRA 17.1 became current as of November 2014.

1.2.19.2. MedDRA level (AP.IND.2)

Low Level Terms (LLT) must be specified.

1.2.19.3. MedDRA Code (AP.IND.3)

The indication(s) is/are to be coded using the English term and corresponding code. Where
a specific language is not supported in MedDRA, the MedDRA Code associated with the
English equivalent term should be used.

If a term of the next official MedDRA version is required, it can be entered as supplemental MedDRA
term.

Multiple terms can be used to code the medical concepts of indication(s), the signs, symptoms or
intended effects. The use of qualifiers (e.g., comorbidities, population specifics) will be possible with
the implementation of the ISO IDMP standards in the Product Management Service (PMS).

It is not necessary to update medicinal product entries when a new MedDRA version is released. In the
context of the data submission maintenance (e.g., if there is a need of notification of a variation with
an 'Update (2)' operation type), if a new MedDRA version is available, the latest current version should
be used to codify the indications.

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As a general principle, when updating the product information, terms deprecated (non-current) in a
new version of MedDRA cannot be referenced in any XEVPRM submitted thereafter and current terms
are to be provided instead.

For coding instructions, please refer to ‘Points to Consider Documents’ available on MedDRA website.
The ‘Summary of Changes to MedDRA Term Selection’ is also available on MedDRA website.

Efforts should be made to capture the most granular and comprehensive level of information available
in MedDRA; where the stage or type of a disease is available, this should be captured as well.

EXAMPLE 61

Scenario 1
Section 4.1 Therapeutic Indications of the SmPC states "Treatment of COPD"
Term coded in MedDRA: COPD (LLT=10010952)

Scenario 2
Section 4.1 Therapeutic Indications of the SmPC states "Treatment of Chronic obstructive pulmonary
disease"
Term coded in MedDRA: Chronic obstructive pulmonary disease (LLT=10009033)

Scenario 3
Section 4.1 Therapeutic Indications of the SmPC states "Treatment of Chronic obstructive pulmonary
disease (COPD)"
Term coded in MedDRA: Chronic obstructive pulmonary disease (LLT=10009033)
Term coded in MedDRA: COPD (LLT=10010952)

EXAMPLE 62

Section 4.1 Therapeutic Indications of the SmPC states "Treatment of motor fluctuations in patients
with Parkinson’s disease"
Term coded in MedDRA: Motor fluctuations (LLT=10067208)

EXAMPLE 63

Section 4.1 Therapeutic Indications of the SmPC states "None. The product is intended as a diluent for
Carwash Powder for Injection"
Term coded in MedDRA: Medication dilution (LLT=10063482)

EXAMPLE 64

Section 4.1 Therapeutic Indications of an Italian SmPC states:

"recidiva di candidiasi orofaringea o esofagea in pazienti con infezione da HIV che sono ad alto rischio
di subire ricadute"

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Term coded in MedDRA:
Oropharyngeal candidiasis recurrent (LLT=10066493)
Oesophageal candidiasis recurrent (LLT=10066491)

Additional MedDRA coding examples

1/
"Drug is indicated in the treatment of osteoporosis in postmenopausal women and in men at increased
risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and
non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis
associated with sustained systemic glucocorticoid therapy in women and men at increased risk for
fracture"

Term coded in MedDRA:

Osteoporosis (LLT= 10031282)

Osteoporosis steroid-induced (LLT=10031287)

Osteoporosis postmenopausal (LLT=10031285)

2/

"Indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the
pancreas"

Term coded in MedDRA:

Pancreatic adenocarcinoma (LLT=10051971)

Pancreatic adenocarcinoma metastatic (LLT=10033599)

Where two or more similar MedDRA terms exist, it is preferable to capture only one of them (e.g.,:
either "Pancreatic adenocarcinoma (LLT=10051971)" or "Adenocarcinoma pancreas (LLT=10052747)"
is acceptable).

3/

EXAMPLE 64.3

"Drug is indicated for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and
ankylosing spondylitis."

Term coded in MedDRA:

Ankylosing spondylitis (LLT= 10002556)

Osteoarthritis (LLT= 10031161)

Rheumatoid arthritis (LLT= 10039073)

4/

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"Drug is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian
carcinoma, in patients with relapsed disease following a recurrence-free interval of at least 6 months
after platinum-based, first-line therapy."

Term coded in MedDRA:

Ovarian epithelial cancer (LLT=10061328)

Ovarian epithelial cancer metastatic (LLT=10033158)

The information related to co-medication and other qualifiers for treatment, target population or health
status or population will not be captured at this stage.

The information related to the status of the disease is to be captured, as available in the current
MedDRA version.

5/

"Drug is indicated for the treatment of patients with unresectable, locally recurrent or metastatic
breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy".

Term coded in MedDRA:

Breast Cancer (10006187)

Breast cancer recurrent (10006198)

Breast cancer metastatic (10055113)

1.2.20. Previous EV Code (AP.PEV.1)

The EV Code of a development product may be specified if the authorised product was
submitted to the XEVMPD in its development form.

The EV Code of an authorised product must be specified in the context of transfer/renewal

of marketing authorisation as applicable.

• If the authorised product was submitted to the XEVMPD in its development form (as a development
medicinal product), this field may contain the EV Code assigned to the development medicinal
product (DMP).

− The referenced EV Code must match a development product EV Code in the XEVMPD.
Failure to comply leads to the generation of a 02 negative acknowledgement and the individual
product is rejected.

• If an authorised medicinal product submitted in the XEVMPD was subject to a marketing

authorisation transfer between organisations registered in EV under separate headquarters, the
new authorised medicinal product entity must reference the EV Code of the previous AMP entity as
applicable.

− The referenced EV Code must match at least one authorised product EV Code in the
XEVMPD. The EV Code of the AMP must not be a nullified EV Code. Failure to comply leads to
the generation of a 02 negative acknowledgement and the individual product is rejected.

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• If an authorised medicinal product submitted in the XEVMPD was subject to a marketing
authorisation transfer within the same organisation (i.e., organisations under the same EV
headquarter), and the MAH used the simplified process to notify the Agency of this transfer, the
updated authorised medicinal product entity must reference the EV Code of the AMP entity that is
being updated as applicable.

See section 2.4.3. Transfer of marketing authorisation of this document for further information on
transfer of marketing authorisation.

• If an authorised medicinal product submitted in the XEVMPD was a subject to a marketing

authorisation renewal where a new marketing authorisation number has been assigned by the
competent authority, the new authorised medicinal product entity must reference the EV Code of
the previous AMP entity as applicable.

− The referenced EV Code must match at least one authorised product EV Code in the
XEVMPD. The EV Code of the AMP must not be a nullified EV Code. Failure to comply leads to
the generation of a 02 negative acknowledgement and the individual product is rejected.

1.2.21. AMP - Printed product information (PPI) attachments

A copy of the SmPC as authorised by the Authorising Body must be provided as a PPI
attachment to the authorised medicinal product entity.

• Where, in exceptional circumstances, the SmPC is not available as part of the marketing
authorisation, an equivalent document that facilitates the data quality assurance process by the
Agency (e.g., English common text, PIL or other similar text as authorised by the Authorising
Body) should be provided.

• In case where the approved SmPC does not state an authorisation number, a date of
authorisation/renewal or the MAH, a copy of the document granting, or renewing the marketing
authorisation should also be provided as an additional PPI attachment.

• If the MAH referenced the composition of the pharmaceutical product [all substance names and the
concentration of the active substance(s)] within the AMP entry as stated in the Module 3 dossier
instead of the SmPC, then an extract of the dossier must also be provided as an attachment.

See section 1.10. Submission of an attachment for further information.

1.2.21.1. Attachment EV Code (AP.PPI.1)

The EV Code of the attachment referring to the authorised medicinal product must be
specified.

• If the attachment to be referenced in the AMP entity was already submitted in the XEVMPD and an
attachment EV Code has been assigned, the attachment can be selected from the available
EudraVigilance look-up table (EVWEB users). Gateway users should populate the 'Attachment EV
Code' field (AP.PPI.1) with the assigned attachment EV Code received in the XEVPRM
Acknowledgement.

The pattern of the EV Code is 'ATT' followed by a number.

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• If the corresponding attachment is not available in the XEVMPD, the attachment can be added
using the attachment section of the XEVPRM.

See section 1.10. Submission of an attachment of this document for further information on how to
submit a PPI attachment in the XEVMPD.

NOTE 13

It is not possible to submit only a PPI attachment entity in an XEVPRM in EVWEB. At least one of the
submitted authorised medicinal products that will refer to the new attachment (SmPC) must also be
present in the same XEVPRM.

1.2.21.2. Attachment validity declaration (AP.PPI.2)

Validity confirmation that the referenced attachment is the latest version of the
documentation must be provided when performing an update or insert of an authorised
product where a referenced PPI attachment was previously loaded in the XEVMPD.

The value 'Valid (1)' specifies that the attachment is the latest version.

----------

When all the above fields required for the submission of an AMP are specified as applicable in the
XEVPRM and following a successful submission of the XEVPRM in the XEVMPD, a local code will be
assigned as an internal reference code, until an EV Code has been provided as part of the
acknowledgement process.

Following a successful insert, an EV Code for the authorised medicinal product entity will be received in
the XEVPRM Acknowledgement.

The pattern of the EV Code for a medicinal product is 'PRD' followed by a number.

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EMA/135580/2012 Page 110/200
1.3. Initial submission of a QPPV information

EU QPPV, and where such does not exist, the local QPPV (e.g., for purely national
authorisations) must register with EudraVigilance.

MAHs are legally required to have a qualified person for pharmacovigilance (QPPV) based in the
European Union (EU) in place at all times, in line with Article 103 of Directive 2001/83/EC.

The Agency uses the QPPV email address provided as the sole contact point for certain important
communications (e.g., in relation to initiation of pharmacovigilance referral procedures concerning
MAHs marketing authorisations), therefore the QPPV information must be up to date.

Detailed information on how to register a QPPV can be obtained on the 'EudraVigilance: How to
register' webpage or in the EMA EudraVigilance Registration Manual.

From 26 July 2018, QPPVs are required to self-register in the EMA Account Management Platform:

• The main QPPV of the MAH organisation must request the 'EV Human MAH EU QPPV' role.

• The trusted deputy that supports the main responsible person must request the 'EV Human
MAH/CS/NCS Trusted Deputy' role.

• Additional QPPV, which is not the EU QPPV user for that profile, may request the 'EV Human MAH
Additional QPPV' role.

Following the self-registration of the QPPV in the EMA Account Management Platform, the QPPV
submits an EMA Service Desk portal request requesting their role to be certified by the EMA. Once the
role is approved by the EMA, the QPPV retrieves the QPPV Code assigned.

The QPPV code can be retrieved by the QPPV and/or MAH users registered under the organisation's HQ
from:

• the restricted area of the EudraVigilance website (accessible to registered users only) under the
"QPPV list":

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EMA/135580/2012 Page 111/200
• or from the look-up table of the "QPPV" field in the XEVMPD Data Entry Tool (EVWEB) (by EVWEB
users).

Any changes of the QPPV details (e.g., change of telephone number/address or surname of the QPPV)
must be updated in the user's profile via the EMA Account Management Platform by the user. The
changes must be made immediately and no later than 30 calendar days from the date the changes
apply.

Detailed guidance on the electronic submission of information on medicinal products

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1.4. Initial submission of an approved substance

New approved substance information is submitted in the XEVMPD in an XEVPRM with the
operation type 'Insert (1)' by the EMA.

The preferred name and alias(es) must be in English.

Substance/alias translation(s) must be provided in all official EU language(s) for CAPs and
all national language(s) of the country/countries of authorisation for NAPs/MRPs/DCPs by
the MAHs.

Each approved substance successfully submitted in the XEVMPD has an assigned EV Code. The
preferred name of the substance is entered in English.

• The name(s) of the substance in individual national languages is/are listed as "Translations".

• The Agency supports non-Latin /accented character set EEA languages. The UTF-8 character set
should be used.

• For WEB Trader users, the submission in non-Latin characters should be done using the XHTML
version of XEVMPD Data Entry Tool (EVWEB) (this option should be selected in the display setting
drop down menu in the top left corner of EVWEB). The only exception is the tree view in XEVMPD
Data Entry Tool (EVWEB), which will not show the non-Latin characters.

• Any synonym(s)/alias(es) of the substance is/are listed as "Synonyms"/"Alias(es)".

As communicated in the 'Changes to some business rules of the eXtended EudraVigilance Medicinal
Product Dictionary (XEVMPD): Submission of substance information' document, in the context of
improvement of the XEVMPD Substance Controlled Vocabulary data quality, the XEVMPD business rules
were revised to reject any operation type related to submission of substances. This implies that any
XEVPRM messages containing operation type 'Insert (1)', 'Update (2)' or 'Nullification (4)' of an
approved or development substance will be rejected and will generate a negative XEVPRM
acknowledgement.

To check if an approved substance is available in the XEVMPD, MAHs should search the XEVMPD
approved substance look-up table in EVWEB or search the substance export lists published on the
Substance Management System (SMS) portal. If the required approved substance is not listed, the
MAHs should request the addition of the substance information via the EMA Service Desk portal.

To request addition of a new approved substance in the XEVMPD:

1. Download and complete the Substance Request Form.

a. Company code can be set as the substance preferred term if the substance is not in the
public domain.

b. Privacy settings can be adjusted for all additional names and molecular formula.

2. Go to the EMA Service Desk portal and create the request using the ‘Request SMS services’
form. In the request:

a. Attach the completed Substance Request Form.

b. Attach supporting documentation for the substance (e.g., SmPC or Investigator’s

Brochure)

3. Finalise and submit the request.

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To request an update of an existing approved substance in the XEVMPD:

1. Go to the EMA Service Desk portal and create the request using the ‘Request SMS services’
form. In the request:

a. reference the EV Code or the preferred name of the substance term to be updated;

b. for a translation, include the translation, language information and reference source;

c. for an alias, include the alias and the reference source;

d. attach supporting documentation (e.g., SmPC or Investigator’s Brochure) or an EV

Code of an existing attachment where the translation/alias are referenced.

2. Finalise and submit the request.

All substance requests are processed by EMA Data Stewards from the Substance Management Service
(SMS). They will validate the request upon pre-registration or update of the substance. 5-10 working
day SLA will be applied. Once the substance is registered, the user will receive an e-mail confirmation
from the EMA Service Desk that substance data has been registered or updated, also stating the EV
Code assigned (if applicable).

Registered or updated substance data will be available for selection in the eAF, XEVMPD, IRIS,
EudraCT, CTIS and EudraGMDP automatically.

Substance related enquiries should be submitted via the EMA Service Desk portal using the ‘Request
for Information’ form:

− in the ‘Service’ field “SPOR” should be selected;

− in the ‘Service offering’ field “SMS” should be selected.

Guidance on how to handle approved substance names is included in the 'EMA Substance names best
practice' document published in section "Data Quality-control methodology" on the 'Guidance
documents related to data submission for authorised medicines' webpage.

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for human use by marketing authorisation holders to the European Medicines Agency in
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EMA/135580/2012 Page 114/200
1.5. Initial submission of a reference source

New reference source information must be submitted in the XEVMPD by the EMA via an
XEVPRM with the operation type "Insert (1)".

Reference source is required only during the submission of an approved substance information in the
XEVMPD. Approved substance information is entered in the XEVMPD by the EMA upon request
submitted via the EMA Service Desk portal.

To support Product Management System (PMS) implementation and RMS/XEVMPD synchronisation, if

the required reference source does not exist in the XEVMPD, MAHs can request the addition of a new
reference source in the XEVMPD via a change request in RMS:

• If the required reference source is available in RMS list named 'Source of Information' (RMS ID:
100000000009) but it is not available in the XEVMPD, MAHs should submit an ‘Update term’
change request via RMS to request the insert of the reference source in the XEVMPD.

• If the required reference source is not available in either system (i.e., RMS and XEVMPD), MAHs
should submit a ‘New term’ change request via RMS to request the insert of the reference
source in the RMS list named 'Source of Information' (RMS ID: 100000000009) and in the
XEVMPD.

An ‘RMS user manual’ is available for download from section ‘Documents’ of the RMS portal. Please
refer to section 3.7. Change Requests of the RMS user manual for further information.

RMS data stewards will assess the change request and provide the requestor with the EV Code of the
reference source term, as applicable.

Reference source element structure:

1.5.1. Local Number (S.1)

Local number is a unique reference number that must be assigned for a reference source
entity in the XEVPRM following an operation type 'Insert' (1).

When a new reference source is submitted in an XEVPRM using the operation 'Insert' (1), a local
number must be assigned to the reference source. When the corresponding XEVPRM Acknowledgement
is received and providing that the submission was successful, this local number should be used to
retrieve the corresponding EV Code.

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EXAMPLE: XEVPRM – Insert of a new reference source

EXAMPLE: XEVPRM Acknowledgement – Insert of a new reference source

1.5.2. EV Code (S.2)

EudraVigilance (EV) Code of the reference source must be specified if the operation type is
NOT an 'Insert'.

I.e., if maintenance related operations are performed on a reference source entity successfully inserted
in the XEVMPD, the EV Code of the reference source entity must be referenced in this field).

1.5.3. Reference source name (S.3)

The reference source name must be provided as mandatory information.

1.5.4. Comment (S.4)

Further information on the reference source may be provided in the comment field, if
required.
When operation type 'Nullification' (4) is performed on a reference source entity, the comment field

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must be populated with the reason for nullification (e.g., "Duplicate of XXX"). Only the owner
organisation (i.e., the organisation that submitted the data and/or its HQ) and the EMA can perform
the nullification.

----------

When all the above fields required for the submission of a reference source are specified as applicable,
and following a successful insert in the XEVMPD, an EV Code for the reference source will be received
in the XEVPRM Acknowledgement.

The pattern of the EV Code for a reference source is 'SRC' followed by a number.

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1.6. Initial submission of a marketing authorisation holder (MAH)
organisation

New organisation information must be submitted in the XEVMPD in an XEVPRM with the
operation type 'Insert (1)'.

The organisation information (i.e., MAH name and MAH address) refer to the legal entity of
the medicinal product in a given country as indicated in section 7. Marketing Authorisation
Holder of the SmPC.

To support PMS implementation and OMS/XEVMPD synchronisation, MAHs are strongly encouraged
required to submit MAH information in the XEVMPD as it was submitted in the Organisation
Management System (OMS), i.e. in accordance with the data quality standards for the organisation
name and address specified by OMS.

The MAH information stated in section 7. Marketing Authorisation Holder of the SmPC may therefore
differ from the information entered in the MAH entity in the XEVMPD. To indicate in the MAH record in
the XEVMPD that the organisation information is reflected as it is entered in OMS, the location ID (LOC
ID) must be referenced in the ‘Comment’ field (0.18) of the MAH organisation entity in the XEVMPD.
This is to facilitate the validation of this information with the organisation details in OMS.

Data quality principles for submission of organisation information in OMS are available in the OMS
portal, section 'Document's, under 'C - OMS Data Quality standards’.

The list of MAH organisations with their assigned EV Codes can be found in:

• the 'MAHs' look-up table in EVWEB,

• in OMS; the EV Code of the MAH organisation record in the XEVMPD can be found, if available, in
section ‘Mappings’ of the relevant organisation.

• An XEVMPD MAH organisations list is also published on the 'Guidance documents related to data
submission for authorised medicines' webpage. However, this published list is not maintained since
February 2023 and therefore does not contain the most up to date information.

NOTE 14

• The MAH name must be submitted providing the name of the legal entity in a given country
regardless of any naming conventions/differences in trade style/characters specified in section 7.
Marketing Authorisation Holder of various SmPCs. The same MAH/legal entity in a given country for
the applicable AMPs must be referenced as appropriate.

• The name and address of the Organisation should be provided consistently and providing the most
complete information e. g. "Avenue" instead of "Av"., "Road" instead of "Rd" etc. unless these are
entered as they are available in OMS.

• The company's legal status does not need to be written in full (e.g., "Ltd." doesn't need to be
changed to "Limited", "S.p.A." doesn't need to be changed to "Societá Per Azioni", GmbH doesn't
need to be changed to "Gesellschaft mit beschränkter Haftung".)

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• MAHs should review that the mapping between OMS and XEVMPD is performed correctly. To do so,
MAHs should review the 'Mappings' section linked to the LOC ID in OMS to check if/which EV Code
corresponding to the MAH entity in the XEVMPD is reflected there.

− If discrepancies are found, or if no EV Code is referenced in the 'Mappings' section of the OMS
entity, please raise a Service Desk request for the OMS team to investigate.

− In case of questions, please raise a Service Desk question for the OMS team:

in the 'Service' section, please reference "SPOR";

in the 'Service Offering' section, please reference "OMS".

EXAMPLE 65

Scenario 1
Section 7. Marketing Authorisation Holder of the SmPC states: "Pharma XYZ Ltd." at the location "X".
The organisation name as stated in the SmPC (i.e., with "Ltd.") is not present in the XEVMPD.
➢ Organisation "Pharma XYZ Limited" at the location "X" is however available in the XEVMPD with
the assigned EV Code ORG1234. It is the same legal entity.
➢ "Pharma XYZ Limited" at the location "X" is also available in OMS.

Since organisation entity ORG1234 already contains the organisation details as the details stated in
section 7. of the SmPC, it should be referenced in the AMP.
It is not necessary to create a new MAH organisation entity in the XEVMPD with the name "Pharma XYZ
Ltd." at the location "X" because "Pharma XYZ Limited" already exists in the XEVMPD and an EV Code
has been assigned.
All AMPs for which "Pharma XYZ Ltd." at the location "X" is the MAH as per the corresponding SmPC
should reference "Pharma XYZ Limited" (ORG1234). Since the organisation details in XEVMPD
correspond to the organisation details in OMS, the MAH should reference the organisation’s LOC ID in
the ‘Comment’ field (0.18) of ORG1234.

Scenario 2
Section 7. Marketing Authorisation Holder of the SmPC states "KPharma Limited" with the address "12
Secret Av, London".
The organisation details as stated in the SmPC (i.e., with "Av" in the address) are not present in
the XEVMPD.
Organisation "KPharma Limited" with the address "12 Secret Avenue, London" is however
available in the XEVMPD with the assigned EV Code ORG0001. It is the same legal entity.
"KPharma Limited" with the address "12 Secret Avenue, London" is also available in OMS.

Since organisation entity ORG0001 already contains the organisation details as the details stated in
section 7. of the SmPC, it should be referenced in the AMP.
It is not necessary to create a new MAH organisation entity in the XEVMPD with the name and address
"KPharma Limited" with the address "12 Secret Av, London".
All AMPs for which "KPharma Limited" with the address "12 Secret Av, London" is the MAH as per the
corresponding SmPC should reference ORG0001 with the address "12 Secret Avenue, London". Since

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the organisation details in XEVMPD correspond to the organisation details in OMS, the MAH should
reference the organisation’s LOC ID in the ‘Comment’ field (0.18) of ORG0001.

Scenario 3:
Section 7. Marketing Authorisation Holder of the SmPC states:
Paráda Pharma s.r.o.

Kramářova 55/225

190 00 Praha 9 – Vysočany

➢ The organisation entity does not exist in the XEVMPD, no MAH EV Code is available.
➢ The organisation entity exists in OMS under location ID LOC-100012345 with the following
details:
Parada Pharma s.r.o.
Kramarova 55/255
Vysocany
Prague 9
190 00

The MAH should submit in the XEVMPD a new MAH entity either referencing the organisation details as
they are stated in section 7 of the SmPC (with or without the special characters) OR, preferably, as
they are entered in OMS. If the MAHs enters the details of the MAH as they are entered in OMS, the
LOC ID LOC-100012345 should be entered in the ‘Comment’ field (0.18) of the MAH organisation in the
XEVMPD.

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MAH Organisation element structure:

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EMA/135580/2012 Page 121/200
Table 4 - Art 57(2) data elements requirements overview for MAH
organisation submission

Reference Schema Field Name EVWEB Field Rules for Art Guidance Link
Code Label 57(2) submission:

M - Mandatory

M*- Mandatory

with conditions

O – Optional

Organisation element
structure
O Organisation

@ O..1 (@) operationtype M Insert (1)

Update (2)
Nullification (4)
as applicable
O.1 type_org Type M 1.6.1.
O.2 name_org MAH name M 1.6.2.
O.3 localnumber M* 1.6.3.
O.4 ev_code EV code M* 1.6.4.
O.5 organisationsenderid MAH sender ID O 1.6.5.
O.6 address Address M* 1.6.6.
O.7 City City M 1.6.7.
O.8 state Region O 1.6.8.
O.9 postcode Postcode M* 1.6.9.
O.10 countrycode Country code M 1.6.10.
O.11 tel_number Tel Number O 1.6.11.
O.12 tel_extension Tel Extension O 1.6.11.
O.13 tel_countrycode Tel Country code O 1.6.11.
O.14 fax_number Fax Number O 1.6.12.
O.15 fax_extension Fax Extension O 1.6.12.
O.16 fax_countrycode Fax Country Code O 1.6.12.
O.17 email E-mail address O 1.6.13.
O.18 comments Comment M* 1.6.14.
O.19 sme_status SME Status M 1.6.15.
O.20 sme_number SME Number O 1.6.16.

1.6.1. Type of organisation (O.1)

The type of organisation must be specified - Marketing Authorisation Holder (MAH) = 1,

Sponsor = 2.

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Only organisation set as MAH can be referenced in an AMP entity.

1.6.2. Organisation name (O.2)

The name of the organisation (MAH) by means of the legal entity of the medicinal product
must be specified as indicated in section 7. Marketing Authorisation Holder of the SmPC or
as entered in the organisation entity in OMS.

See NOTE 14 for related information.

1.6.3. Local Number (O.3)

Local number is a unique reference number that must be assigned for an organisation entity
in the XEVPRM following an operation type 'Insert' (1).

When a marketing authorisation holder (MAH) organisation is submitted in an XEVPRM using the
operation 'Insert' (1), a local number must be assigned to this MAH organisation. When the
corresponding XEVPRM Acknowledgement is received and providing that the submission was
successful, this local number should be used to retrieve the corresponding EV Code.

EXAMPLE: XEVPRM – Insert of MAH Organisation

EXAMPLE: XEVPRM Acknowledgement – Insert of MAH Organisation

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1.6.4. EV Code (O.4)

The EudraVigilance (EV) Code of the MAH organisation must be specified if the operation
type is NOT an 'Insert'.

I.e., if maintenance related operations are performed on an MAH organisation entity successfully
inserted in the XEVMPD, the EV Code of the MAH organisation entity must be referenced in this field).

1.6.5. Organisation Sender Identifier (O.5)

The ID of the organisation that corresponds to the same organisation as assigned in the
EudraVigilance registration system may be provided.

1.6.6. Address (O.6)

The address of the MAH must be specified as stated in section 7. Marketing Authorisation
Holder of the SmPC as entered in the organisation entity in OMS.

1.6.7. City (O.7)

The city of the MAH must be specified as stated in section 7. Marketing Authorisation Holder
of the SmPC or as entered in the organisation entity in OMS.

1.6.8. State (O.8)

The state (region) of the MAH may be specified as stated in section 7. Marketing
Authorisation Holder of the SmPC.

1.6.9. Postcode (O.9)

The postcode of the MAH must be specified as stated in section 7. Marketing Authorisation
Holder of the SmPC or as entered in the organisation entity in OMS.

1.6.10. Country Code (O.10)

The country code of the MAH must be specified as stated in section 7. Marketing
Authorisation Holder of the SmPC.

The country code is to be specified using the ISO-3166-1 standard. The official list of ISO 3166-1
country codes is maintained by the International Organization for Standardization (ISO).

• The country code "GR" corresponding to "Greece" should be used for locations in Greece.

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The country code "GB" corresponding to "United Kingdom" should be used for locations in England,
Wales, and Scotland.

• The country code "XI" corresponding to "United Kingdom (Northern Ireland)" should be used for
locations in Northern Ireland.

1.6.11. Telephone number (O.11)/Extension (O.12)/Country Code (O.13)

The telephone number, extension and telephone country code may be specified.

1.6.12. Fax number (O.14)/Extension (O.15)/Country Code (O.16)

The fax number, extension and fax country code may be specified.

1.6.13. Email address (O.17)

The email address of a contact point authorised for communication with the EMA on behalf
of the marketing authorisation holder shall be specified.

This communication may involve procedural regulatory matters (e.g., notification of non-
pharmacovigilance referrals).

1.6.14. Comment (O.18)

Further information on the organisation may be provided in the comment field, if required.

When operation type 'Nullification' (4) is performed on an organisation entity, this field must reference
the reason for nullification (e.g., "Duplicate of XXX"). Only the owner organisation (i.e., the
organisation that submitted the data and/or its HQ), and the EMA, can perform the nullification.

See section 2.2. Maintenance of a marketing authorisation holder (MAH) organisation entity for related
information.

When entering organisation details as per MAH information entered in OMS, the OMS location ID must
be entered in this field to facilitate the validation of this information with the organisation details in
OMS.

1.6.15. SME status (O.19)

The SME status applicable to the MAH organisation must be selected.

The following values are available:

- N/A (1) – to be used by non-SMEs;

- Micro (2);

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- Small (3);

- Medium (4).

The definitions for medium, small and micro sized enterprises (SME) are laid down in Commission
Recommendation 2003/361/EC:

• Micro enterprises – with less than 10 employees and an annual turnover or balance sheet total of
not more than € 2 million;

• Small enterprises – with less than 50 employees and an annual turnover or balance sheet total of
not more than € 10 million.

• Medium enterprises – with less than 250 employees and an annual turnover of not more than € 50
million or balance sheet total of not more than € 43 million.

SMEs must also meet the following criteria:

• They must be located in the EEA;

• They must declare any partner or linked enterprise in the ownership structure of the enterprise.

It remains the responsibility of the MAHs to ensure that the information on the size of the organisation
is accurate.

Companies are advised to verify the status of their company as a micro, small or medium enterprise by
sending a declaration directly through to the Agency's SME office.

To keep administrative burden on companies to a minimum, the Agency uses the European
Commission’s model declaration, which has been designed to promote the application of Commission
Recommendation 2003/361/EC on the definition of SMEs.

The verification of the SME status by the SME office can be performed in parallel with the update of
product entries by MAHs. The SME number obtained as a result of the verification process may be
submitted at a later date with the continual update of product changes by MAHs.

Micro- and small-sized enterprises which had their status verified in order to benefit from
the EudraVigilance fee waiver MedDRA subscription are advised to renew their SME status
as applicable.

Further information on how to register as a SME is available on the SME Office area of the EMA
website.

The Agency actively monitors the SME status of companies. The Agency reserves the right to request
further information from MAHs to establish that the SME criteria are met.

1.6.16. SME number (O.20)

The SME number may be provided if available.

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When all of the above fields required for the submission of an MAH organisation are specified as
applicable, and following a successful submission in the XEVMPD, a local code will be assigned as an
internal reference code until an EV Code has been provided as part of the acknowledgement process.

Following a successful insert, an EV Code for the MAH Organisation entity will be received in the
XEVPRM Acknowledgement.

The pattern of the EV Code for an Organisation is 'ORG' followed by a number.

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1.7. Initial submission of an ATC Code

A new ATC Code must be submitted in the XEVMPD by the EMA as a standard or proposed
term in an XEVPRM with the operation type 'Insert (1).

MAHs may request the addition of the ATC Code in the XEVMPD via a change request in RMS.

Prior to submitting the RMS change request, marketing authorisation holders are advised to consult the
ATC code mapping list named 'D3 - XEVMPD-RMS_WHO-National ATC codes mapping' available
in the 'Documents' section of the Referentials Management Service (RMS) portal to determine if an
existing standard ATC code can referenced in the AMP instead.

1. If an ATC code is included in the ATC Index published by the WHO but is missing in RMS
and/or in the XEVMPD, continue with steps 2a or 2b, as applicable.

2. If an ATC code is not included in the ATC Index published by the WHO, the MAH should
request the ATC code to be added in the Index by submitting an application to the WHO.

Once a confirmation on whether the ATC code will be published either as provisional or final is
received from the WHO, the MAH should send a ‘change request’ through the RMS portal (with
the confirmation from WHO as an attachment) to include the ATC code in the RMS list:

a. If the required ATC Code is available in RMS but it is not available in the XEVMPD, an
‘Update term’ change request should be submitted via the RMS portal to request
the insert of the ATC Code in the XEVMPD:

i. The justification field in the ‘CR Information’ section of the change request
should clearly state that the code is missing in XEVMPD and should be added
there.

ii. The ‘ATC Human list’ should be selected in the ‘Select List’ field, and the
relevant ATC code should be selected in the ‘Select Term’ field as shown in the
example below:

iii. All the fields in the ‘Term Information’ section should be left unchanged except
for the ‘Mappings’ section (highlighted in yellow in the below screenshot) where
the XEVMPD-related information should be inserted:

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 iv. ‘Extended EudraVigilance Medicinal Product Dictionary’ should be selected in
the ‘Source’ field; the ATC code should be populated in the ‘Source term ID’
field, and the field ‘Main Source’ should always be set to “No” for XEVMPD
codes.

See the below an example for illustrative purposes:

b. If the required ATC code is not available in RMS nor in the XEVMPD, a ‘New term’
change request should be submitted via the RMS portal to request the insert of the
ATC Code in RMS and in the XEVMPD.

i. The justification field in the 'CR Information' section of the change request
should clearly state that the code is missing in RMS and in XEVMPD and should
be added in both systems.

ii. If the ATC code is not yet published on the WHO ATC website, please provide a
letter from WHO confirming the ATC code as an attachment.

An ‘RMS user manual’ and the ‘D4 - XEVMPD-RMS Change Requests process’ are available for
download from section ‘Documents’ of the RMS portal. Please refer to section 3.7. Change
Requests of the RMS user manual for further information.

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EMA/135580/2012 Page 129/200
 The EMA will then enter the ATC Code in RMS/XEVMPD before the official yearly update from
WHO and inform the requestor.

All five levels of the ATC code can be used. The most specific ATC code in relation to the medicinal
product needs to be specified in the AMP entry in the XEVMPD.

An ATC Code element structure:

EXAMPLE: XEVPRM – Insert of a proposed ATC Code

EXAMPLE: XEVPRM Acknowledgement – Insert of a proposed ATC Code

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1.7.1. Type Term (ST.ATC.1)

The type of term must be specified.

The following values are available:

• Development Term (1): can only be used in Development product entries;

• Proposed (2): can be entered by the EMA only and referenced in authorised and/or development
product entries;
• Standard Term (3): can be entered by the EMA only and referenced in authorised and/or
development product entries.

1.7.2. ATC Code (ST.ATC.2)

The ATC Code must be specified.

A proposed ATC Code must not match a current standard ATC Code in the XEVMPD.

1.7.3. New owner ID (ST.ATC.3)

Available for EMA use only.

1.7.4. ATC Code description (ST.ATC.4)

The ATC code description in English must be specified.

EXAMPLES – ATC Code description: "tetracycline"; "oxytetracycline, combinations"; "central nervous

system"

1.7.5. Version Date Format (ST.ATC.5)

Format of the version date should correspond to "102" for "CCYYMMDD".

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1.7.6. Version Date (ST.ATC.6)

The date of the last update of the specified ATC code may be specified.

1.7.7. Comment (ST.ATC.7)

Further information on the ATC Code may be provided in the comment field, if required.
When operation type 'Nullification' (4) is performed on a proposed ATC Code entity, the 'Comment'
field must be populated with the reason for nullification (e.g., "Duplicate of XXX"). Only the owner
organisation and the EMA (i.e., the organisation that submitted the data and/or its HQ) can perform
the nullification.

-----------

When all the above fields required for the submission of a proposed ATC Code are specified as
applicable, and following a successful insert in the XEVMPD, an EV Code for the ATC Code will be
received in the XEVPRM Acknowledgement.

RMS data stewards will confirm to the requestor when the requested proposed/standard ATC Code is
available in the XEVMPD.

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1.8. Initial submission of an authorised/administrable pharmaceutical
form

New pharmaceutical form must be submitted in the XEVMPD by the EMA as a standard or
proposed term in an XEVPRM with the operation type 'Insert (1)''.

To support PMS implementation and RMS/XEVMPD synchronization, if the required pharmaceutical

form does not exist in the XEVMPD as a standard or a proposed term, and providing that the
pharmaceutical form cannot be re-mapped to another standard term, MAHs can request the addition of
a new pharmaceutical form in the XEVMPD via a change request in RMS:

• If the required pharmaceutical form is available in RMS but it is not available in the XEVMPD, MAHs
should submit an ‘Update term’ change request via RMS to request the insert of the
pharmaceutical form in the XEVMPD.

• If the required pharmaceutical form is not available in either system (i.e., RMS and XEVMPD),
MAHs should submit a ‘New term’ change request via RMS to request the insert of the
pharmaceutical form in RMS and in the XEVMPD.

An ‘RMS user manual’ and the ‘D4 - XEVMPD-RMS Change Requests process’ are available for
download from section ‘Documents’ on the RMS portal. Please refer to section 3.7. Change Requests of
the RMS user manual for further information.

RMS data stewards will assess the change request and provide the requestor with the EV Code of the
pharmaceutical form as applicable.

In the context of improvement of the XEVMPD Controlled Vocabulary data quality and following a
consultation with EDQM, some proposed pharmaceutical forms have been re-mapped to standard
pharmaceutical forms in the XEVMPD production system.

Prior to submitting the RMS change request, marketing authorisation holders are advised to consult the
pharmaceutical form mapping list named 'D1 - XEVMPD-RMS_EDQM Pharmaceutical Dose Form
terms mapping' available in the 'Documents' section of the Referentials Management Service (RMS)
portal first to determine if an existing standard pharmaceutical form term can be referenced in the AMP
instead.

Pharmaceutical form element structure:

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1.8.1. Type Term (ST.PF.1)

The type of term must be specified.

The following values are available:

− Development Term (1): can only be used in Development product entries

− Proposed (2): to be referenced in Authorised and Development product entries
− Standard Term (3): available to EMA only

1.8.2. Local Number (ST.PF.2)

Local number is a unique reference number that must be assigned for a pharmaceutical form
entity in the XEVPRM following an operation type 'Insert' (1).

When a pharmaceutical form is submitted in an XEVPRM using the operation 'Insert' (1), a local
number must be assigned to this pharmaceutical form entity. When the corresponding XEVPRM
Acknowledgement is received and providing that the submission was successful, this local number
should be used to identify the corresponding EV Code.

EXAMPLE: XEVPRM – Insert of a proposed pharmaceutical form

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EXAMPLE: XEVPRM Acknowledgement – Insert of a proposed pharmaceutical form

1.8.3. EV Code (ST.PF.3)

EudraVigilance (EV) Code of the pharmaceutical form must be specified if the operation type
is NOT an 'Insert'.

I.e., if maintenance related operations are performed on a pharmaceutical form entity successfully
inserted in the XEVMPD, the EV Code of the pharmaceutical form entity must be referenced in this
field.

1.8.4. New owner ID (ST.PF.4)

This field is available for EMA use only.

1.8.5. Name of the Pharmaceutical Form (ST.PF.5)

The name of the pharmaceutical form in English must be specified.

EXAMPLES - Pharmaceutical Form name: tablet, capsule

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1.8.6. Version Date Format (ST.PF.6)

Format of the version date should correspond to "102" for "CCYYMMDD".

1.8.7. Version Date (ST.PF.7)

The date of the last update of the specified pharmaceutical form code may be specified.

1.8.8. Previous EV Code (ST.PF.8)

For a Proposed pharmaceutical form Term, this field may be used to make a reference to the
EV Code of the Development pharmaceutical form Term if previously submitted in the
XEVMPD.

For a Development Term this field is not applicable.

1.8.9. Comment (ST.PF.9)

Further information on the pharmaceutical form may be provided in the comment field, if
required.
When operation type 'Nullification' (4) is performed on a proposed/development pharmaceutical form
entity, the comment field must be populated with the reason for nullification (e.g., "Duplicate of XXX").
Only the owner organisation (i.e., the organisation that submitted the data and/or its HQ) and the EMA
can perform the nullification.

----------

Following a successful insert, an EV Code for the pharmaceutical form entity will be received in the
XEVPRM Acknowledgement.

The pattern of the EV Code for a pharmaceutical form is 'PDF' followed by a number.

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1.9. Initial Submission of a route of administration (RoA)

New route of administration must be submitted in the XEVMPD by the EMA as a standard or
as a proposed term in an XEVPRM with the operation type 'Insert (1)'.

MAHs may request the addition of the RoA term in the XEVMPD via a change request in RMS.

To support PMS implementation and RMS/XEVMPD synchronization, if the required route of

administration does not exist in the XEVMPD as a standard or a proposed term, MAHs can request the
addition of a new route of administration in the XEVMPD via a change request in RMS:

• If the required route of administration is available in RMS but it is not available in the XEVMPD,
MAHs should submit an ‘Update term’ change request via RMS to request the insert of the
route of administration in the XEVMPD.

• If the required route of administration is not available in either system (i.e., RMS and XEVMPD),
MAHs should submit a ‘New term’ change request via RMS to request the insert of the route of
administration in RMS and in the XEVMPD.

An ‘RMS user manual’ and the ‘D4 - XEVMPD-RMS Change Requests process’ are available for
download from section ‘Documents’ on the RMS portal. Please refer to section 3.7. Change Requests of
the RMS user manual for further information.

RMS data stewards will assess the change request and provide the requestor with the EV Code of the
pharmaceutical form as applicable.

In the context of improvement of the XEVMPD Controlled Vocabulary data quality and following a
consultation with EDQM, some proposed Routes of Administration have been re-mapped to Standard
RoA in the XEVMPD production system.

Prior to submitting the RMS change request, marketing authorisation holders are advised to consult the
route of administration mapping list named 'D2 - XEVMPD-RMS_EDQM Route of Administration
terms mapping' available in the 'Documents' section of the Referentials Management Service (RMS)
portal first to determine if an existing standard route of administration term can referenced in the AMP
instead.

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Administration route element structure:

1.9.1. Type Term (ST.AR.1)

The type of term must be specified.

The following values are available:

− Development Term (1): can only be used in Development product entries

− Proposed (2): to be referenced in Authorised and Development product entries
− Standard Term (3): available to EMA only

1.9.2. Local Number (ST.AR.2)

Local number is a unique reference number that must be assigned for a RoA entity in the
XEVPRM following an operation type 'Insert' (1).

When a RoA is submitted in an XEVPRM using the operation 'Insert' (1), a local number must be
assigned to this RoA entity. When the corresponding XEVPRM Acknowledgement is received and
providing that the submission was successful, this local number should be used to identify the
corresponding EV Code.

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EXAMPLE: XEVPRM – Insert of a proposed route of administration

EXAMPLE: XEVPRM Acknowledgement– Insert of a proposed route of administration

1.9.3. EV Code (ST.AR.3)

EudraVigilance (EV) Code of the RoA must be specified if the operation type is NOT an
'Insert'.

I.e., if maintenance related operations are performed on a RoA entity successfully inserted in the
XEVMPD, the EV Code of the RoA entity must be referenced in this field.

1.9.4. New owner ID (ST.AR.4)

This field is available for EMA use only.

1.9.5. Name of the Route of Administration (ST.AR.5)

The name of the route of administration in English must be specified.

EXAMPLES – Route of administration name: Oral use, Subcutaneous use

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1.9.6. Version Date Format (ST.AR.6)

Format of the version date should correspond to "102" for "CCYYMMDD".

1.9.7. Version Date (ST.AR.7)

The date of the last update of the specified route of administration code may be specified.

1.9.8. Previous EV Code (ST.AR.8)

For a Proposed (RoA) Term, this field may be used to make a reference to the EV Code of the
Development (RoA) Term if previously submitted in the XEVMPD.

For a Development Term this field is not applicable.

For a Standard Term this field should refer to the EV Code of the previous Proposed or Development
Term.

1.9.9. Comment (ST.AR.9)

Further information on the RoA may be provided in the comment field, if required.
When operation type 'Nullification' (4) is performed on a proposed/development RoA entity, the
comment field must be populated with the reason for nullification (e.g., "Duplicate of XXX"). Only the
owner organisation (i.e., the organisation that submitted the data and/or its HQ) and the EMA can
perform the nullification.

----------

Following a successful insert, an EV Code for the Route of Administration entity will be received in the
XEVPRM Acknowledgement.

The pattern of the EV Code for a route of administration is 'ADR' followed by a number.

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1.10. Submission of an attachment

An attachment is any allowed file that is sent in the zip file containing the XEVPRM message with the
information:

• For medicinal products, Printed Product Information (PPI) must be submitted as an attachment.

• For substances, Printed Substance Information (PSI) may be submitted as an attachment to a

substance related request submitted via the EMA Service Desk portal (see section 1.4. Initial
submission of an approved substance of this document for related information).

Format of an attachment

Attachments can be provided in the following formats: .PDF, .DOC, .DOCX, .XLS and .XLSX.

• The allowed file types for PPI (i.e., SmPC/PIL/marketing authorisation decision) are: .PDF (1),
.DOC (2), .DOCX (3).

• The allowed file types for PSI (i.e., substance information) are .PDF (1), .DOC (2), .DOCX (3),
XLS (4) and .XLSX (5).

Marketing authorisation holders are not to send PDF scanned documents (except for documents
granting or renewing marketing authorisation) but need to provide "genuine" PDF documents.

For PDF attachments, PDF file version 1.4 or 1.7 should be used as these are the only two versions
that are ISO standards compliant. They are used for long term preservation of information and
therefore the Agency/MAHs will have the assurance that we will be able to open them for many years.

Content of an attachment

A copy of the SmPC as authorised by the Authorising Body should be provided.

• In case where the approved SmPC does not state an authorisation number, a date of
authorisation/renewal or the MAH, a copy of the document granting, or renewing the marketing
authorisation should also be provided as an additional PPI attachment.

• Where, in exceptional circumstances, the SmPC is not available as part of the marketing
authorisation, an equivalent document that facilitates the data quality assurance process by the
Agency (e.g., English common text, PIL or other similar text as authorised by the Authorising
Body) should be provided.

• If the MAH referenced the composition of the pharmaceutical product [all substance names and the
concentration of the active substance(s)] within the AMP entry as stated in the Module 3 dossier
instead of the SmPC, then an extract of the dossier must also be provided as an attachment.

Content of attachments cannot be updated. Updated attachment(s) must be resubmitted, when

necessary, in the context of the data maintenance submission, i.e., when the variations lead to
changes to the sections of the SmPC as highlighted in section of this document for further information.

Only the latest version of the SmPC for a medicinal product is retrievable/visible by the user. Non-
current PPI versions will be archived.

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NOTE 15

• In Member States with more than one official language(s), where medicinal product information is
available in more than one language(s) and the corresponding SmPC/Patient Information Leaflet
(PIL)/other similar text as authorised by the Authorising Body is therefore available in such
language(s), the medicinal product should be submitted in the XEVMPD for each of the available
language(s). The Printed Product Information (PPI) attached to each of the AMP entity/entities
should correspond to the applicable language(s).

• If one document (e.g., SmPC) contains information in two languages (e.g., in Finland), it is
possible to indicate this in the attachment entity by referencing two language codes in the
'Language code' (ATT.6) section. See section 1.10.7. 2nd Language code (ATT.7) for further
information.

• The list of official languages per country can be found on the Agency's website.

• See also Table 1b - Requirements for AMP records and attachments for countries with more than
one national language for related information.

• In Member States where an SmPC in the national language might not be available, the text from
another Member State may be used (e.g., Belgian SmPC is accepted in Luxembourg, therefore AMP
authorised in Luxembourg can contain the Belgium SmPC as an attachment). See EXAMPLE 69 .

• For centrally authorised products, the SmPC to be used for reference must be in English.

Attachment information can be added using the attachment section of the XEVPRM (see Table 61.
Attachment elements of Chapter 3.I of the Detailed Guidance for further information).

It is not possible to submit a standalone PPI unless it is submitted via a Gateway solution or EV Post
functionality. In EVWEB, the PPI attachment must be referenced in at least one product entity
submitted in the same XEVPRM.

EXAMPLE 66 - Belgium

Medicinal product "Skyprod® 250 mg/ml, oplossing voor injectie" is authorised in Belgium with the
authorisation number "BE12345".

The Federal Agency for Medicines and Health Products has authorised the SmPC in French and Dutch,
the patient information leaflet is available in French, Dutch and German.

Three AMP entities should be therefore submitted in the XEVMPD, one entity for each of the official
languages (Dutch, French and German). The relevant PPI attachment must be referenced in the
corresponding AMP entity:

AMP entity 1:
PPI to be attached = SmPC in Dutch

"Authorisation country code" (AP.12.1) = Belgium (BE)

"Authorisation number" (AP.12.4) = BE12345
"Full Presentation Name" (AP.13.1) = Skyprod® 250 mg/ml, oplossing voor injectie
"Product Short Name" (AP.13.2) = Skyprod

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"Product INN/Common Name" (AP.13.3) = <this field should be left blank>
"Product Company Name" (AP.13.4) = <this field should be left blank>
"Product Strength Name" (AP.13.5) = 250 mg/ml
"Product Form Name" (AP.13.6) = oplossing voor injectie

AMP entity 2:
PPI to be attached = SmPC in French

"Authorisation country code" (AP.12.1) = Belgium (BE)

"Authorisation number" (AP.12.4) = BE12345
"Full Presentation Name" (AP.13.1) = Skyprod® 250 mg/ml, solution injectable
"Product Short Name" (AP.13.2) = Skyprod
"Product INN/Common Name" (AP.13.3) = <this field should be left blank>
"Product Company Name" (AP.13.4) = <this field should be left blank>
"Product Strength Name" (AP.13.5) = 250 mg/ml
"Product Form Name" (AP.13.6) = solution injectable

AMP entity 3:
PPI to be attached = PIL in German

"Authorisation country code" (AP.12.1) = Belgium (BE)

"Authorisation number" (AP.12.4) = BE12345
"Full Presentation Name" (AP.13.1) = Skyprod® 250 mg/ml, lnjektionslösung
"Product Short Name" (AP.13.2) = Skyprod
"Product INN/Common Name" (AP.13.3) = <this field should be left blank>
"Product Company Name" (AP.13.4) = <this field should be left blank>
"Product Strength Name" (AP.13.5) = 250 mg/ml
"Product Form Name" (AP.13.6) = lnjektionslösung

EXAMPLE 67 - Malta

Medicinal product "Rydimprod 80 mg tablets" is authorised in Malta with the authorisation number
"MA123/4567".
The Maltese NCA has authorised the SmPC in English only.

Although there are two official languages in Malta (Maltese and English), only one AMP entity should be
submitted in the XEVMPD, because the Maltese NCA has authorised the SmPC and PIL in English only.
PPI to be attached = SmPC in English
"Authorisation country code" (AP.12.1) = Malta (MT)
"Authorisation number" (AP.12.4) = MA123/4567
"Full Presentation Name" (AP.13.1) = Rydimprod 80 mg tablets

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"Product Short Name" (AP.13.2) = Rydimprod
"Product INN/Common Name" (AP.13.3) = <this field should be left blank>
"Product Company Name" (AP.13.4) = <this field should be left blank>
"Product Strength Name" (AP.13.5) = 80 mg
"Product Form Name" (AP.13.6) = tablets

EXAMPLE 68 - Finland

In Finland, there are two official languages. The SmPCs for medicinal products authorised in the
national procedure exist in Finnish and Swedish. Patient Information Leaflets are available in Finnish
and Swedish.
Therefore, for medicinal product authorised in Finland via a NAP/MRP/DCP, two AMP entities should be
submitted to the XEVMPD:

AMP entity 1:

PPI to be attached = SmPC in Finnish

The presentation name elements in data fields AP.13.1 - AP.13.6 must be entered based on the
medicinal product name stated in section 1. Name of the medicinal product of the corresponding SmPC
(i.e., in Finnish). The substance name(s) are also to be specified as reflected in the SmPC (i.e., in
Finnish).

AMP entity 2:
PPI to be attached = SmPC in Swedish
The presentation name elements in data fields AP.13.1 - AP.13.6 must be entered based on the
medicinal product name stated in the corresponding Patient Information Leaflet (i.e., in Swedish). The
substance name(s) are also to be specified as reflected in the Patient Information Leaflet (i.e., in
Swedish).

Since the same SmPC contains the product information in both languages, the same document can be
referenced in both product entries. The attachment entity should indicate that the content is available
in two languages by referring the two language codes in the ‘Attachment’ entity.

See section 1.10.7. 2nd Language code (ATT.7) for related information.

EXAMPLE 69 - Luxembourg

In Luxembourg, there are three official languages (French, German and Luxembourgish).
Since SmPCs/PILs of medicinal products authorised in Belgium/Germany/Austria are accepted in
Luxembourg, an AMP authorised in Luxembourg can contain the SmPC/PIL of an AMP authorised in
Belgium/Germany/Austria as an attachment.

Scenario 1 – MAH submits to the Luxembourgish Authority a Belgian SmPC in French as well as PIL in
German.
Two AMP entities should be submitted in the XEVMPD:

AMP entity 1:
PPI to be attached = SmPC in French

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The presentation name elements in data fields AP.13.1 - AP.13.6 must be entered based on the
medicinal product name stated in section 1. Name of the medicinal product of the corresponding SmPC
(i.e., in French). The substance name(s) are also to be specified as reflected in the SmPC (i.e., in
French).
AMP entity 2:
PPI to be attached = Patient Information Leaflet in German
The presentation name elements in data fields AP.13.1 - AP.13.6 must be entered based on the
medicinal product name stated in the corresponding Patient Information Leaflet (i.e., in German). The
substance name(s) are also to be specified as reflected in the Patient Information Leaflet (i.e., in
German).

Scenario 2 – MAH submits to the Luxembourgish Authority a Belgian SmPC in French.

One AMP entity should be submitted in the XEVMPD:
AMP entity 1:
PPI to be attached = SmPC in French
The presentation name elements in data fields AP.13.1 - AP.13.6 must be entered based on the
medicinal product name stated in section 1. Name of the medicinal product of the corresponding SmPC
(i.e., in French). The substance name(s) are also to be specified as reflected in the SmPC (i.e., in
French).

Scenario 3 - MAH submits to the Luxembourgish Authority an Austrian SmPC in German.

One AMP entity should be submitted in the XEVMPD:
AMP entity 1:
PPI to be attached = SmPC in German
The presentation name elements in data fields AP.13.1 - AP.13.6 must be entered based on the
medicinal product name stated in section 1. Name of the medicinal product of the corresponding SmPC
(i.e., in German). The substance name(s) are also to be specified as reflected in the SmPC (i.e., in
German).

Attachment element structure:

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1.10.1. Local number (ATT.1)

Local number is a unique reference number that must be assigned for an attachment entity
in the XEVPRM following an operation type 'Insert' (1).

When an attachment is submitted in an XEVPRM using the operation 'Insert' (1), a local number must
be assigned to this attachment entity. When the corresponding XEVPRM Acknowledgement is received
and providing that the submission was successful, this local number should be used to identify the
corresponding EV Code.

1.10.2. File name (ATT.2)

The file name of the attachment with file extension must be specified.

The file name for the attachment can be assigned by the marketing authorisation holder; there is no
naming convention to be followed. Non-ASCII characters are not allowed for the attachment file name.

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1.10.3. File type (ATT.3)

The file type of the attachment must be specified as applicable.

The allowed file types for PPI (i.e., SmPC/PIL/marketing authorisation decision) are: .PDF (1), .DOC
(2), .DOCX (3).

The allowed file types for PSI (i.e., substance information) are .PDF (1), .DOC (2), .DOCX (3), .XLS (4)
and .XLSX (5).

1.10.4. Attachment name (ATT.4)

The name of the attachment given by the sender should be specified.

1.10.5. Attachment type (ATT.5)

The type of attachment must be specified.

Allowed values are:

- Printed Product Information (PPI) = 1

- Printed Substance Information (PSI) = 2

1.10.6. Language code (ATT.6)

The code for the language of the attachment must be specified (using the "LANGUAGE"
reference list).

1.10.7. 2nd Language code (ATT.7)

A second code for the language of the attachment may be specified (using the "LANGUAGE"
reference list) if the content of the same document in provided in two languages.

EXAMPLE:

If the content of the attachment is provided in one language only, this field should remain blank.

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1.10.8. Attachment version (ATT.8)

The version of the PPI/PSI attachment must be specified.

The version number and version date refer to the 'internal' reference of the marketing authorisation
holder and do not need to appear on the physical document (i.e., the SmPC document attached). The
version number and version date allow the Agency to understand if the version of the SmPC has
changed over time.

Where the version date is reflected on the physical document, it should be reflected as presented in
the SmPC Section 10. Date of revision of text.

1.10.9. Attachment version date (ATT.9)

The date of the last update of the PPI/PSI document must be specified.

The version number and version date refer to the 'internal' reference of the marketing authorisation
holder and do not need to appear on the physical document (i.e., the SmPC document attached). The
version number and version date allow the Agency to understand if the version of the SmPC has
changed over time.

Where the version date is reflected on the physical document, it should be reflected as presented in
the SmPC Section 10. Date of revision of text. When the date is not stated in the physical document,
the date when the SmPC has been approved by the NCA can be provided.

1.10.10. Version date format (ATT.10)

The value must be "102" for "CCYYMMDD".

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Following a successful insert, an EV Code for the attachment entity will be received in the XEVPRM
Acknowledgement.

The pattern of the EV Code for an attachment is 'ATT' followed by a number.

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1.11. Initial submission of a Pharmacovigilance System Master File (PSMF)
information

The information on the marketing authorisation holder's Pharmacovigilance System Master

File must be submitted using the Master File Location section of an XEVPRM with operation
type 'Insert' (1).

The Pharmacovigilance system master file definition is provided in Article 1(28e) of Directive
2001/83/EC and the minimum requirements for its content and maintenance are set out in the
Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance
Activities Provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC (the Implementing
Regulation is referenced as IR). The detailed requirements provided by the Commission Implementing
Regulation are further supported by the guidance in the Guideline on good pharmacovigilance practices
(GVP): Module II – Pharmacovigilance system master file:

The PSMF shall be located within the EU, either at the site where the main pharmacovigilance activities
are performed or at the site where the qualified person responsible for pharmacovigilance operates [IR
Art 7(1)], irrespective of the format (paper-based or electronic format file). Following European
Economic Area (EEA) agreements, the PSMF may also be located in Norway, Iceland or Liechtenstein.

At the time of marketing authorisation application, the applicant should submit electronically the PSMF
location information using the agreed format [IR Art26 1(a)], and subsequently include in the
application, the PSMF reference number, which is the unique code assigned by the EudraVigilance (EV)
system to the master file when the EudraVigilance Medicinal Product Report Message (XEVPRM) is
processed. Further to the granting of a marketing authorisation, the PSMF will be linked by the
marketing authorisation holder to the EVMPD product code(s). All PSMFs must be registered in the
Article 57 database.

The required location information for the PSMF is a physical office address of the marketing
authorisation holder or a contracted third party. Where the PSMF is held in electronic form, the location
stated must be a site where the data stored can be directly accessed, and this is sufficient in terms of
a practical electronic location [IR Art 7(3)].

For the purpose of the Article 57(2) notifications on the PSMF location, the following should be taken
into account:

• In accordance with Article 3 of Regulation (EU) NO 1235/2010 (the pharmacovigilance legislation),

the obligation on the part of the MAHs to maintain and make available on request a
Pharmacovigilance System Master File (PSMF) will apply "… to marketing authorisations granted
before 2 July 2012 as from either:

(a) the date on which those marketing authorisations are renewed; or

(b) the expiry of a period of 3 years starting from 2 July 2012,

whichever is the earlier.

Therefore, from 2 July 2015 MAHs are required to submit the Pharmacovigilance System Master
File information to the Article 57 database (aka XEVMPD).

• To request an EV Code for a PSMF, the following three characteristics need to be taken into
account:

i. The marketing authorisation holder (MAH) as a legal entity

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 ii. The location of the PSMF

iii. The Pharmacovigilance System (PS)

The following case scenarios provide explanations, as to when and how an EV Code for a PSMF needs
to be requested by the same marketing authorisation holder:

Table 5 – Requesting a single/multiple PSMF EV Code(s) by the same MAH

Scenario 1 Scenario 2 Scenario 3

MAH Same Same Same

Location Same Same Different
PV System Same Different Different
Number of EV Codes to
1 >1 >1
request
Comment (MF.11) field
Not required Not required Not required
information

• Scenario 1:

MAH A has a PSMF location D for the PV system X and therefore submits one PSMFL entity in the
Article 57 database; one PSMFL EV Code is assigned.

• Scenario 2:

MAH A has two different PV systems Y and Z, each with a separate PSMF in the same location
R. MAH A shall submit two PSMFL entities in the Article 57 database/XEVMPD; two PSMFL EV Codes
will be assigned:

1/ one EV Code will be assigned for the PV System Y and corresponding PSMF at location
R; and

2/ another EV Code will be assigned for the PV System Z and corresponding PSMF at the
same location R.

• Scenario 3:

MAH A has different PV systems Y and Z, each with a separate PSMF in different locations R
and S. MAH A shall submit two PSMFL entities in the Article 57 database; two PSMFL EV Codes will
be assigned:

1/ one for the PV System Y and corresponding PSMF at location R; and

2/ one for the PV System Z and corresponding PSMF at location S.

In the context of the requirement set out in Article 8(3) of the Directive 2001/83/EC related to the
submission of the summary of the PV system information and the requirement to submit
electronically the PSMF location information within the XEVMPD, a single PSMF cannot refer to
multiple locations. Therefore, the same MAH A cannot register different locations for the same
PSMF describing the same PV system.

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In the case where the MAH changes the location of the PSMF, the maintenance submission applies as
described in section 2.3. Maintenance of a Pharmacovigilance System Master File Location (PSMFL)
entity of this document.

The following case scenarios provide explanations as to when and how an EV Code for a PSMFL needs
to be requested by various marketing authorisation holders at different levels (i.e., HQ or affiliates as
specified in the EV Registration database):

Table 6 – Requesting a single/multiple PSMFL EV Code(s) by different

MAHs

Scenario 4 Scenario 5

4a 4b 4c 5a 5b 5c

MAH Different Different Different Different Different Different

Are MAHs
registered in the
EV Registration
database under Same Same Same Different Different Different

the same Global

company (HQ)?

Location Same Same Different Same Same Different

PV System Same Different Different Same Different Different
Number of EV
Codes to be 1 >1 >1 >1 >1 >1
requested
List the
EVCODE
assigned
to the
PSMF
Comment
Not Not Not when it Not
(MF.11) field Not required
required required required was first required
information
registered
in the
system by
the other
MAH

• Scenario 4a:

MAH A and MAH B are different legal entities belonging to the same global company MAH A
and B share the same PV system Y at the same location R. Both MAH A and MAH B share the
same PSMFL EV Code.

I.e.: MAH A is registered in the EV Registration database as an affiliate of organisation C. MAH B is

also registered in the EV Registration database as an affiliate of organisation C. Because both MAHs

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 share the same PV system at the same location, both should reference the same PSMFL EV Code in
their respective AMPs. Since both organisations are affiliates of the same HQ organisation, if MAH A
submits a PSMFL entity in the Article 57 database and an EV Code is generated, MAH B will be able
to retrieve this PSMFL EV Code in EVWEB.

• Scenario 4b:

MAH A and MAH B are different legal entities belonging to the same global company. MAH A
and B have different PV systems Y and Z at the same location R. Therefore, each MAH
requests their own individual EV Code, which they will reference in their AMPs.

• Scenario 4c:

MAH A and MAH B are different legal entities belonging to the same global company. MAH A
and B have different PV systems Y and Z at different location R and S. MAH A has a PSMF at
location R for one PV system Y; MAH B has a PSMF at location S for one PV system Z. Therefore,
each MAH requests their own individual EV Code, which they will reference in their AMPs.

• Scenario 5a:

MAH A and MAH B are different legal entities belonging to different global companies. MAH A
and B share the same PV system Y at the same location R. Both MAH A and MAH B request a
separate EV Code. In order to identify that the separate EV Codes refer to the same PV system Y
(and corresponding PSMF) describing the same single PV system Y at the same location R, each
MAH is required to include in the "Comment" field (MF.11) of the PSMF location entity the EV Code
assigned to the other MAH. In case one MAH has already acquired an EV Code, it is acceptable that
the other MAHs sharing the same PV system include this PSMFL EV Code in the "Comment" field
(MF.11).

I.e.: MAH A is registered in the EV Registration database as a headquarter organisation. MAH B is

also registered in the EV Registration database as a headquarter organisation. Since both
organisations are separate unrelated organisations, if MAH A submits a PSMFL entity in the Article
57 database and an EV Code is generated, MAH B will NOT be able to retrieve this PSMFL EV Code
in EVWEB and reference it in their AMPs. Because both MAHs share the same PV systems at the
same location, each MAH should submit a separate PSMFL entity in the Article 57 database, stating
the EV Code of the PSMFL submitted by the other MAH in the "Comment" field (MF.11). This means
that two PSMFL EV Codes will be generated and each of the MAH will reference a different PSMFL
EV Code in their AMPs. The link between the two PSMFL EV Codes will be through the information
in the PSMFL "Comment" field (MF.11).

• Scenario 5b:

MAH A and MAH B are different legal entities belonging to different global companies. MAH A
and B have different PV systems Y and Z at the same location R. Therefore, each MAH
requests their own individual EV Code, which they will reference in their AMPs.

• Scenario 5c:

MAH A and MAH B are different legal entities belonging to different global companies. MAH A
and B have different PV systems Y and Z at different location R and S. MAH A has a PSMF at
location R for one PV system X; MAH B has a PSMF at location S for one PV system Z. Therefore,
each MAH requests their own individual EV Code, which they will reference in their AMPs.

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See the Guideline on good pharmacovigilance practices (GVP): Module II – Pharmacovigilance system
master file (Rev 2) for related information.

Organisations registered with Eudravigilance can submit the PSMF location information using the
Master File Location section of the XEVPRM (see Table 7. Master File Location elements of Chapter 3.I:
Technical specifications) with the operation type 'Insert' (1) in EVWEB or their Gateway.

Master file location element structure:

1.11.1. Local Number (MF.1)

The local number is a unique reference number that must be assigned for an MFL entity in
the XEVPRM following an operation type 'Insert' (1).

When an MFL is submitted in an XEVPRM using the operation 'Insert' (1), a local number must be
assigned to this MFL entity. When the corresponding XEVPRM Acknowledgement is received and
providing that the submission was successful, this local number should be used to identify the
corresponding EV Code.

EXAMPLE: XEVPRM – Insert of MFL information

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EXAMPLE: XEVPRM Acknowledgement – Insert of MFL

1.11.2. EV Code (MF.2)

EudraVigilance (EV) Code of the MFL must be specified if the operation type is NOT an
'Insert'.

I.e., if maintenance related operations are performed on a MFL entity successfully inserted in the
XEVMPD, the EV Code of the MFL entity must be referenced in this field.

1.11.3. Pharmacovigilance System Master File Company (MF.3)

The name of the company that holds the PSMF may be specified where applicable.

1.11.4. Pharmacovigilance System Master File Department (MF.4)

The name of the department that holds the PSMF may be specified where applicable.

1.11.5. Pharmacovigilance System Master File Building (MF.5)

The building name, if part of the address, may be specified where applicable.

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1.11.6. Pharmacovigilance System Master File Street (MF.6)

The street of the address where the master file is located must be specified.

1.11.7. Pharmacovigilance System Master File City (MF.7)

The city of the address where the master file is located must be specified.

1.11.8. Pharmacovigilance System Master File State (MF.8)

The state/region of the address where the master file is located may be specified.

1.11.9. Pharmacovigilance System Master File Postcode (MF.9)

The postcode of the address where the master file is located must be specified.

1.11.10. Pharmacovigilance System Master File Country code (MF.10)

The country code of the address where the master file is located must be specified.

1.11.11. Comment (MF.11)

Internal reference to distinguish which PSMF is related to the specific PSMF Location EV
Code may be included as outlined in table scenario 5a.

When operation type 'Nullification' (4) is performed on MFL entity, the comment field must be
populated with the reason for nullification (e.g., "Duplicate of XXX"). Only the owner organisation (i.e.,
the organisation that submitted the data and/or its HQ) and the EMA can perform the nullification.

----------

Following a successful insert, an EV Code for the MFL entity will be received in the XEVPRM
Acknowledgement. The pattern of the EV Code for a master file location is 'MFL' followed by a number.

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2. Maintenance of medicinal product data

Scope and objectives

This chapter defines the maintenance of information of medicinal products submitted by marketing
authorisation holders in accordance with the provisions laid down in Article 57(2) of Regulation
726/2004.

From 16 June 2014 until ISO IDMP implementation, marketing authorisation holders are required to
amend the authorised medicinal product entities submitted in the XEVPRM format in compliance with
the requirements of Article 57(2) of Regulation (EC) 726/2004. The guidance and processes described
in this chapter should be followed during the 'transition maintenance phase' [i.e., the transition to the
ISO Identification of Medicinal Product (IDMP) standards implementation].

A long-term strategy for the implementation of the ISO IDMP standards is currently being developed
by the Agency, taking into account the potential impact on the European Regulatory Network, EU
stakeholders and international partners. Information related to the implementation of ISO IDMP
standards in the European Union can be found on the 'Data on medicines (ISO IDMP standards):
Overview' webpage.

The scope of the 'transition maintenance phase' submission is:

• to collect up-to-date information on authorised medicinal products initially submitted under the
Article 57(2) requirements in the XEVMPD by correcting any erroneously submitted information;

− for Gateway user this includes the reconciliation of the medicinal product data against the new
EV Code provided in the XEVMPD CVs following the quality control activities performed by the
Agency (i.e., XEVMPD substance names, pharmaceutical forms and routes of administration
CVs),

• to reflect any changes to the terms of the marketing authorisations following variation, transfer,
renewal, suspension, revocation or withdrawal of the marketing authorisation procedure within the
XEVMPD/Article 57 database structured and non-structured information as per timelines set in the
Legal Notice on the Implementation of Article 57(2) of Regulation (EC) No. 726/2004 (within 30
calendar days from the date of which the amendments have been authorised);

• to continue the submission of new authorised medicinal products in the XEVMPD as per timelines
set in the Legal Notice on the Implementation of Article 57(2) of Regulation (EC) No. 726/2004
(within 15 calendar days from the date of authorisation).

The 'transition maintenance phase' as described in this guidance document enables the Agency to
establish a complete and reliable database on medicinal product information to support the following
areas:

• performance of data analysis at the Agency and specifically:

- EudraVigilance (EV) data analysis and signal management,

- coding and providing of reporting possibilities on medicinal product and substance information
within Individual Case Safety Reports (ICSRs),

- to support data analytics and business intelligence activities;

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• facilitate medicines regulation and fulfil regulatory actions and legal obligation such as:

- regulatory action to safeguard public health (e.g., referrals, PSUR repository, literature
monitoring),

- calculation of Pharmacovigilance fee;

• communicate efficiently with EMA stakeholders by means of:

- establishing a European medicines web portal,

- granting access to EudraVigilance data proactively and reactively,

- supporting EU and international data exchange on demand,

- supporting the Pharmacovigilance Risk Assessment Committee (PRAC) for any communication
with its stakeholders.

Transition maintenance phase - Electronic submission plan

Between 16 June 2014 and 31 December 2014 at the latest, marketing authorisation holders were
required to:

• update, complete, and improve the quality of medicinal products submitted in the context of Art
57(2) of Regulation (EC) No 726/2004; and

• provide to the Agency additional information on all medicinal products submitted under Article
57(2) provisions and in compliance with the new XEVPRM format as published by the Agency on
31st January 2014.

As of 1 January 2015, marketing authorisation holders are required to notify to the Agency any
subsequent changes to the terms of marketing authorisations following variation, transfer, renewal,
suspension, revocation, or withdrawal of the marketing authorisation as soon as possible and no later
than 30 calendar days from the date of which the changes have been authorised using the electronic
XEVPRM format as amended on 31 January 2014.

Marketing authorisation holders should notify the Agency about amendments to the terms of
marketing authorisations which require a revision of the information on medicinal products as
referred to in paragraph 3 and 4 of the Legal Notice on the Implementation of Article 57(2) of
Regulation (EC) No. 726/2004 and the applicable structured data elements (mandatory/mandatory
with conditions) of the electronic XEVPRM format as amended by the Agency on 31 January 2014. More
specifically, notifications of the amendments to the terms of the marketing authorisation include:
• notification of extensions of marketing authorisations as defined in paragraph 1 and 2 of
Annex I of Regulation (EC) 1234/2008: changes to the active substance(s), strength,
pharmaceutical form and route of administration;

• notification of variations to the terms of marketing authorisations as set out in Regulation

(EC) 1234/2008 that is affecting the following XEVPRM structured data elements (mandatory/
mandatory with conditions):

- SmPC Section 1. Name of the medicinal product e.g., change in the (invented) name of the
medicinal product,

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 - SmPC Section 2. Qualitative and quantitative composition e.g.: changes to the active
substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza,

- SmPC Section 3. Pharmaceutical Form e.g., change(s) to a pharmaceutical form, which does
not result in a "new pharmaceutical form" (the latter requires the submission of an Extension
application),

- SmPC Section 4.1 Therapeutic indications e.g., addition of a new therapeutic indication or
modification of an existing one,

- SmPC Section 4.2 Posology and method of administration (routes of administration only) e.g.,
change(s) to route(s) of administration,

- SmPC Section 5.1 Pharmacodynamic properties e.g., change in ATC code,

- SmPC Section 6.1 List of excipients e.g., change or addition of excipient(s),

- SmPC Section 7. Marketing Authorisation Holder e.g., a change of name and/or address of the
MAH;

• notification of any changes to the name and the contact details of the qualified person
responsible for pharmacovigilance (QPPV) in accordance with Article 4(4) of Commission
Implementing Regulation (EU) no 520/2012;

• notification of any changes in the location of the Pharmacovigilance system master file
(PSMF);

• notification of any changes to the contact information for Pharmacovigilance enquiries;

• notifications of transfers of marketing authorisations;

• notifications of any suspension/lifting of the suspension, revocation or withdrawal of a

marketing authorisation granted in the Union;

• notifications of any suspension/lifting of the suspension, revocation or withdrawal of a

marketing authorisation granted in the Union including the following circumstances:

− the marketing authorisation was not renewed by the relevant competent authority,

− an application was not submitted for renewal by the marketing authorisation holder, or

− the marketing authorisation expired due to sunset clause;

• notifications of renewal of the marketing authorisation;

• notification of the electronic copy of the latest approved Summary of Product

Characteristics (SmPC) where any variations lead to a significant revision of the content
of the following sections:
− section 4.1 Therapeutic indications which do not have a direct impact on the MedDRA coding of
the indication,
− section 4.2 Posology and method of administration (other than route of administration),

− section 4.3 Contraindications,

− section 4.4 Special warnings and precautions for use,

− section 4.5 Interaction with other medicinal products and other forms of interaction,#

− section 4.6 Fertility, Pregnancy and lactation,

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 − section 4.8 Undesirable effects,

− section 4.9 Overdose.

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2.1. Maintenance of a Qualified Person responsible for Pharmacovigilance
(QPPV)

MAHs are legally required to have a qualified person for pharmacovigilance (QPPV) based in the
European Union (EU) in place at all times, in line with Directive 2001/83/EC Article 104(3)(a).

The QPPV must be registered under the organisation’s profile in EudraVigilance.

MAH organisations with QPPVs residing in the UK and/or carrying their tasks in the UK should also note
sections 4 and 5 of the 'Commission Notice – Application of the Union’s pharmaceutical acquis in
markets historically dependent on medicines supply from or through parts of the United Kingdom other
than Northern Ireland' and information in DIRECTIVE (EU) 2022/642 OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 12 April 2022 amending Directives 2001/20/EC and 2001/83/EC as regards
derogations from certain obligations concerning certain medicinal products for human use made
available in the United Kingdom in respect of Northern Ireland and in Cyprus, Ireland and Malta.

The contact details of the Qualified Person responsible for Pharmacovigilance (QPPV) refer to the
contact details from where the QPPV operates.

From 1 February 2016 MAH organisations no longer need to notify the EMA or the national competent
authorities (as applicable) of changes to the QPPV by submitting a type IAIN variation. From this date,
the Article 57 database is considered functional for the purpose of notifying changes in QPPV including
contact details (telephone and fax numbers, postal address and email address) through the Article 57
database only. No final variation is required to notify an explicit cross reference to Article 57 as the
source of QPPV information.

Changes to the QPPV information must be notified in the affected medicinal product entities in the
Article 57 database using one of the below business processes (as applicable) immediately and no later
than 30 calendar days from the date the change applies:

1. business process to notify the change of the QPPV details (same person) e.g., changes of
telephone number/address or surname;

2. business process to notify the change of the QPPV within the organisation (change of person)
e.g., QPPV retires, new QPPV is appointed.

The Agency uses the QPPV email address provided as the sole contact point for certain important
communications (e.g., in relation to initiation of pharmacovigilance referral procedures concerning
MAHs marketing authorisations), therefore the QPPV information must be up to date.

2.1.1. Business process to notify the change of QPPV's details

From 26 July 2018 the QPPV/RP is required to make changes of the QPPV's details (e.g., change of
telephone number/address or surname) in their profile via the EMA Account Management Platform
and/or in the 'Manage your contact details' section of the EV Restricted area. Please refer to the EMA
EudraVigilance Registration Manual for related information.

The change of QPPV's details does not affect any medicinal product entries referencing the QPPV as the
same QPPV Code continues to be referenced in the relevant AMP and there is therefore no need for the
MAH to perform an update of the AMP entities.

The following business process should be followed to notify a change to the QPPV's details (same
person):

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 160/200
Process map 3 – Change of QPPV's details

2.1.2. Business process to notify a change of a QPPV

From 26 July 2018, when a new QPPV is appointed in an MAH organisation, the organisation must
nominate a new QPPV within 10 calendar days; the new QPPV must self-register for the relevant QPPV
role [i.e., either as the 'EU QPPV' (at a HQ level) or as an 'additional QPPV' (at an affiliate level)] via
the EMA Account Management Platform.

There can only be one EU QPPV per HQ organisation. The existing EU QPPV cannot be removed from
EudraVigilance until their replacement is fully registered in the EMA Account Management Platform.

The registration of an 'EU QPPV' (at a HQ level) via the EMA Account Management Platform is approved
by the EMA following the receipt of a request submitted via the EMA Service Desk. A set of documents
must be submitted with the request as indicated in the document 'New Organization First User
QPPV/RP or Change of EU QPPV/RP' document.

• The registration of an 'additional QPPV' (at an affiliate level) and/or the trusted deputy is approved
by the EU QPPV of the MAH organisation.

• When a new QPPV is appointed at an EU level (i.e., for the MAH HQ organisation) the QPPV that is
no longer valid will need to de-register from the EU QPPV role via the EMA Account Management
Platform and a new QPPV will need to request a registration for this role.

For information on how to register, refer to the published EMA EudraVigilance Registration Manual.

Following the registration of the new QPPV, a new QPPV Code is assigned. The MAH can retrieve this
QPPV Code from:

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 161/200
• the EudraVigilance restricted area (accessible to registered users only) under "QPPV list" (by
Gateway/EVWEB users):

• or via the 'QPPV' look-up table in the XEVMPD Data Entry Tool (EVWEB) (by EVWEB users).

Following a change of the QPPV, the MAH should amend any AMPs with valid marketing authorisation
statuses in the XEVMPD by performing an 'Update' (2) of the AMP records to reference the new QPPV
Code.

In cases when the marketing authorisation of a medicinal product is transferred to a new MAH but the
QPPV remains the same, the QPPV must be registered (via the EMA Account Management Platform)
under the EV profile of the new MAH. This is because the QPPV is linked to the organisation profile
under which they are registered in the EV registration database. It is not technically possible to
reference a QPPV registered under a profile of another organisation unless there is an affiliate and HQ
relationship between both organisations.

Therefore, to be referenced in the AMPs submitted from the organisation ID of the new MAH, the QPPV
of the former MAH must be registered as a QPPV (or a trusted deputy QPPV or additional QPPV) of the
new MAH. This can be arranged by the QPPV by self-registering under the required organisation profile
(e.g., as an 'additional QPPV') in the EMA Account Management Platform.

EXAMPLE:

Product A was transferred from MAH A to MAH B.

Both MAH organisations are registered in EV as two separate HQ organisations.

The QPPV of MAH A remains the QPPV of Product A for a certain period. Therefore, for the QPPV of
MAH A to be referenced in the product submitted from MAH B's profile, the QPPV must be registered
under the EV profile of MAH B (new QPPV Code will be assigned).

The following business process should be followed to notify a change of QPPV (different person) within
the organisation:

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 162/200
Process map 4 – Change of a QPPV

START
A QPPV change in an MAH organisation needs to be notified.

1.
Is there already an EU QPPV no
registered under the MAH s
profile in the EV registration
database?

yes

Additional QPPV (at

an affiliate level) or 2.
2.1. The new QPPV self-registers in the EMA Account
trusted deputy Is the change related to a change
Management Platform under the required MAH s EV
of the EU QPPV or to an additional
registration profile for the role of an additional
QPPV (e.g. at an affiliate level) or
QPPV or trusted deputy as required.
trusted deputy?

2.2. The EU QPPV approves the role.

EU QPPV

2.3. The QPPV Code of the newly appointed

additional QPPV/trusted deputy can be retrieved in 3. The current EU QPPV removes their
the restricted area of the EV website or in the QPPV role as the EU QPPV in the EMA Account
field in EVWEB. Management Platform.

4.
4.1 The user should request the yes
Is the person to be registered as
role of the EU QPPV under the
the new QPPV already registered under
required MAH s EV registration
the MAH s profile in the EV
profile via the EMA Account
registration database
Management Platform.
(e.g. as a user)?

no

5. The new QPPV self-registers for the

role of the EU QPPV in the EMA
Account Management Platform under
the required MAH s EV registration
profile

6. The new QPPV submits a request via

the EMA Service Desk portal requesting
their role as the new EU QPPV to be
certified by the EMA.
The relevant documents must be
provided as part of the request.

7. The EV Registration team validate the

role by checking the request and the
provided documentation.

8. Following a successful registration

and validation by the EMA the QPPV
Code of the newly appointed EU QPPV
can be retrieved in the restricted area of
the EV website or in the QPPV field in
EVWEB.

9. yes
Continue
Do any AMPs in the XEVMPD
with step
need to be amended to reflect
9.1
the change of QPPV?

no

END

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 163/200
 Step 9.1

A B C
If the QPPV is referenced in AMPs with If the QPPV is referenced If the QPPV is referenced
any of the “Valid” MA statuses in AMPs with any of the ‘Not-Valid’ MA statuses in nullified AMPs

A.1 Identify the AMPs that reference the

Since the AMPs reference the QPPV that was
QPPV you wish to replace
applicable at the time of invalidation/nullification
no action is required on these AMPs

A.2 ‘Update (2)’ the AMPs to reference

the new QPPV

END

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 164/200
2.2. Maintenance of a marketing authorisation holder (MAH) organisation
entity

Variations to the information of the marketing authorisation holder (MAH) may trigger one of the
following business processes:

2.2.1. Notification of change of contact details, name and/or address of the

MAH (i.e., no change of the legal entity)

Change of contact details, name and/or address of an MAH, if the organisation remains the same legal
entity, should be reflected by performing an 'Update (2)' on the existing MAH organisation entity
(i.e., an EV Code is already assigned) or an 'Insert (1)' of a new MAH entity (new EV Code will be
assigned).

If an update of information is performed on an existing MAH entity, then all AMP entities referencing
that MAH organisation entity will display the updated MAH information.

If the name and/or address of the MAH are not yet updated in section 7. of the SmPC(s) for the AMP(s)
with any of the 'Valid' marketing authorisation statuses in the XEVMPD:

➢ The AMPs referencing SmPCs that do not yet contain the new details of the MAH should
continue to reference the existing MAH entity (i.e., with the old details).

➢ A new MAH entity with the updated details should be entered in the XEVMPD using operation
type 'Insert (1)'. New organisation EV Code will be assigned.

➢ The AMPs referencing SmPCs that already contain the new details of the MAH should be
updated [operation type 'Update (2)'] to reference this new MAH entity.

Update of the organisation EV Code in the XEVMPD will not trigger the update of the MAH's details in
the EudraVigilance Registration database.

To amend details of the MAH organisation in the list of organisations registered with EudraVigilance in
the restricted area of the EudraVigilance Human website a change request must be raised in the
Organisations Management System (OMS). Information on how to amend organisation details in OMS
can be found in the OMS web user manual available in the 'Documents' section of the OMS portal, in
section 8.2. Change request process – general rules.

2.2.2. Notification of transfer of marketing authorisation (i.e., change of

the legal entity)

The business process to notify the transfer of marketing authorisation (i.e., change of the Legal entity)
is described in section 2.4.3. Transfer of marketing authorisation of this document.

MAHs are required to correct and reconcile MAH organisation details using an XEVPRM with the
assigned operation types 'Insert' (1), 'Update' (2) and 'Nullification' (4) as described below.

Only the owner organisation (i.e., the organisation that submitted the data and/or its HQ) and the EMA
can perform maintenance related operation types 'Update' (2) and 'Nullification' (4) on an MAH entity
in the XEVMPD.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 165/200
When a new MAH organisation information (new MAH EV Code) is required, the operation type 'Insert
(1)' must be used to submit a new MAH organisation entity in the XEVMPD in an XEVPRM; a new MAH
EV Code will be assigned. This newly submitted organisation should then be referenced in AMPs with
any of the 'Valid' MA statuses for which the attachments reference the updated organisation details
(e.g., in section 7 of the SmPC). See section 1.6. Initial submission of a marketing authorisation holder
(MAH) organisation of this document for related information.

• Amendment of information within an existing organisation entity should be performed by

submitting an XEVPRM with operation type 'Update (2)' on the existing MAH entity. All AMP
entities referencing the MAH organisation entity, for which the details were amended, will
automatically reference the amended/added information.

• MAH organisation entity, which is duplicated (i.e., multiple EV Codes are assigned to the same
organisation entity), obsolete (the organisation is not/will not be referenced in any product
submissions) or erroneously submitted should be nullified by submitting an XEVPRM with operation
type 'Nullification (4)'; the text "Obsolete entity" or "Duplicate of ORGXXX" (where ORGXXX
represents an EV Code) should be entered in the 'Comment (O.18)' field.

The following must be taken into consideration:

a) Nullification of a duplicated/obsolete MAH entity can only be performed by the owner

organisation if the MAH entity has not been validated by the EMA and it is referenced in
nullified AMPs; the text "Obsolete entity" or "Duplicate of ORGXXX" (where ORGXXX
represents an EV Code) should be entered in the 'Comment (O.18)' field.

b) Nullification is not allowed on MAH organisation entities validated (i.e., the 'Validity' field
displays 'Valid') by the EMA in the XEVMPD. Only the EMA can nullify such MAH organisation
entities providing that they are referenced only in nullified or invalidated (i.e., referencing a
'not-valid' MA status) AMPs. To request the nullification, the MAH should submit a
nullification request using the EMA Service Desk portal. The EV Code of the MAH organisation
entity, the requestor's organisation name and EudraVigilance registration ID, and the reason
for nullification must be included in the request.

c) If the duplicated/obsolete MAH entity is referenced in AMPs with any of the 'Valid'
marketing authorisation statuses the AMPs should be updated [i.e., operation type
'Update (2)' should be used] to reference another MAH entity, which will be retained in the
XEVMPD before the nullification can be performed.

d) If the duplicated/obsolete MAH entity to be nullified is referenced in AMPs with any of the
'Not-Valid' marketing authorisation statuses the MAH should submit a request for
nullification by the EMA using the EMA Service Desk portal. The EV Code of the MAH
organisation entity, the requestor's organisation name and EudraVigilance registration ID,
and the reason for nullification must be included in the request.

Following the submission of an XEVPRM in the XEVMPD, the MAH should refer to the XEVPRM
Acknowledgment to check it the performed action has been successful.

The below business processes describe how to:

• notify changes to the MAH details (same organisation/legal entity);

• notify an MAH entity as 'non-current'.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 166/200
Process maps 5 – Change of MAH details

MAH needs to notify a change of MAH organisation details

Change of organisation’s details (i.e. the

Change of legal entity
same legal entity remains)

1. Raise a change request in the 1. Raise a change request in the

Organisations Management system (OMS) Organisations Management system (OMS)

2.Continue with the process described in

section 2.4.3. Transfer of marketing
authorisation

END

2.
Is the MAH entity
yes
referenced only in AMPs with any of
the ‘not-valid’ MA statuses and/or
in nullified AMPs?

no

3.
Is the MAH entity no
referenced in any AMPs with a
‘valid’ MA status?

yes

4.
no Do all of the AMPs
4.1 ‘Insert’ (1) a new MAH organisation
with a ‘valid’ MA statuses reference
with the new details in the XEVMPD; a
an attachment (e.g. SmPC) with the
new EV Code will be assigned
MAH’s updated details?

yes

4.2 ‘Update (2)’ the AMPs that

reference SmPCs, which already state 5. ‘Update (2)’ the existing MAH entity
the MAH’s updated information (in in the XEVMPD.
section 7 of the SmPC). Reference the
newly inserted MAH entity

END

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 167/200
Process map 6 – Notifying an MAH entity as 'non-current'

START
MAH needs to flag an MAH organisation entity that is duplicated, obsolete or was
entered in error as non-current in the XEVMPD

1. yes
Does the same MAH entity 1.1. Identify the MAH organisation entity that
exist in the XEVMPD with multiple is considered the duplicate
EV Codes?

no

2.
Continue yes
Is the MAH entity to be flagged as non-
with step
current referenced in any AMPs?
2.1

no

3.1 Request the nullification yes 3.

via the EMA Service Desk using the Is the MAH entity flagged as validated
Request XEVMPD/Art.57 Services form in the XEVMPD?

no
4.1 Only the owner organisation and/or
its HQ can nullify this MAH entity. no 4. Is your organisation
the owner of this MAH entity
Contact the EMA Service Desk
in the XEVMPD?
for further information using the
Request for Information form
yes

5. Nullify the MAH entity by submitting

an XEVPRM with Nullification ’
assigned to the MAH entity

In the Comment (O.18) field enter the

text: Obsolete entity or Duplicate of
ORGXXX as applicable

END

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 168/200
 Step 2.1

A B C
If the MAH entity is referenced in AMPs If the MAH entity is referenced: If the MAH entity is referenced only in
with any of the Valid MA statuses END nullified AMPs
• only in AMPs with a Not-Valid MA
status; or
• only In AMPs with a Not-Valid MA status
A.1 Identify the AMPs referencing the and AMPs that are nullified
MAH entity you wish flag as non-current Continue
You will need to reference another MAH with step
entity in these AMPs 3

A.2
A.2.1 Insert ’ a new MAH entity in no Is the MAH entity you wish to
the XEVMPD; new EV Code will be reference in the AMPs instead already
assigned available in the XEVMPD?

yes

A.3 Update ’ the AMPs to reference

the correct/current MAH entity

Continue
with step
2

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 169/200
2.3. Maintenance of a Pharmacovigilance System Master File Location
(PSMFL) entity

As per information in the Guideline on good pharmacovigilance practices (GVP): Module II –

Pharmacovigilance system master file:

• Marketing authorisation holders shall continue to ensure that their entries in the Article 57
database for medicinal products for human use are up-to-date, including the information about the
qualified person responsible for pharmacovigilance (QPPV), name and contact details (telephone
and fax numbers, postal address and email addresses) and PSMF location information [based on IR
Art 4(4)].

• Upon a change in the QPPV or location of the PMSF information, the Article 57 database shall be
updated by the marketing authorisation holder immediately and no later than 30 calendar days, in
order to have the information in the Article 57 database and on the European medicines web-portal
referred to in Article 26(1) of Regulation (EC) No 726/2004 updated and to allow continuous
supervision by the competent authorities [based on IR Art 4(4), REG Art 57(2)(c)].

Changes to the information on the Pharmacovigilance system may trigger the generation of new PSMFL
EV Code(s) in the Article 57 database. Please refer to the guidance provided in Table 5 – Requesting a
single/multiple PSMF EV Code(s) by the same MAH and Table 6 – Requesting a single/multiple PSMFL
EV Code(s) by different MAHs.

MAH organisations with Pharmacovigilance System Master File located in the UK should also note
information in the 'Questions and answers to Stakeholders on the implementation of the Protocol on
Ireland/Northern Ireland' document.

In accordance with Article 3 of Regulation (EU) NO 1235/2010 (the pharmacovigilance legislation), the
obligation on the part of the MAHs to maintain and make available on request a Pharmacovigilance
System Master File (PSMF) will apply "… to marketing authorisations granted before 2 July 2012 as
from either:

(a) the date on which those marketing authorisations are renewed; or

(b) the expiry of a period of 3 years starting from 2 July 2012,

whichever is the earlier.

Therefore, from 2 July 2015 MAHs are required to submit the Pharmacovigilance system information to
the Article 57 database.

From 1 February 2016 MAH organisations no longer need to notify EMA or national competent
authorities (as applicable) of changes to the pharmacovigilance system data by submitting a type IAIN
variation. From this date Article 57 database is considered functional for the purpose of notifying
changes to the location of the PSMF (street, city, postcode, country) through the Article 57 database
only. No final variation is required to notify an explicit cross reference to Article 57 as the source of
PSMF information.

MAHs are required to correct and reconcile the pharmacovigilance system information by using the
operation types 'Insert (1), 'Update' (2) and 'Nullification' (4) on a PSMFL entity in the Article 57
database as follow:

• When a new pharmacovigilance system code is required, the operation type 'Insert' (1) must be
used to submit the new PSMFL entity in the XEVMPD in an XEVPRM.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 170/200
 A new PSMFL entity should be submitted in the Article 57 database only in case where the
Pharmacovigilance System changes; a new PSMFL EV Code will be generated.

• Information within a previously submitted PSMFL entity must be amended, or additional

information must be added (as applicable) by submitting an XEVPRM with the operation type
'Update' (2) on an existing PSMFL entity. All AMP entities referencing the PSMFL entity for which
the details were amended will automatically reference the amended/added information.

Should the location of the PSMF change but the Pharmacovigilance System remains the same, the
existing PSMFL EV Code should be amended using an operation type 'Update (2)' to reference
the new location.

• PSMFL entity which is duplicated (i.e., multiple EV Codes are assigned to the same PSMFL entity),
obsolete (the PSMFL is not/will not be referenced in any product submissions) or erroneously
submitted (e.g., the entity was not supposed to be submitted) can be flagged as 'non-current' by
submitting an XEVPRM with the operation type 'Nullification' (4).

Nullification should be performed on the PSMFL entity depending on the type of medicinal product
entities in which the PSMFL entity is referenced. The following must be taken into consideration:

− The duplicated/obsolete PSMFL can be nullified by the owner organisation if the PSMFL entity is
referenced in nullified AMPs; the text "Obsolete entity" or "Duplicate of MFLXXX" (where
MFLXXX represents an EV Code) should be entered in the 'Comment (MF.11)' field of the
PSMFL entity.

− If the duplicated/obsolete PSMFL entity is referenced in AMPs with any of the 'Valid'
marketing authorisation statuses:

a) the AMPs should be updated [i.e., operation type 'Update (2)' should be used] to reference
another PSMFL entity, which will be retained in the XEVMPD; and

b) the duplicated/obsolete PSMFL entity should be nullified [i.e., operation type ‘Nullification
(4)' should be used] referencing the text "Obsolete entity" or "Duplicate of MFLXXX" in the
'Comment (MF.11)' field of the PSMFL entity.

− If the duplicated/obsolete PSMFL is referenced in AMPs with any of the 'Not-Valid'

marketing authorisation statuses and nullified AMPs the PSMFL should be nullified [i.e.,
operation type Nullification (4) should be used] to reference the text "Obsolete entity" or
"Duplicate of MFLXXX" in the 'Comment (MF.11)'field of the PSMFL entity.

Following the submission of an XEVPRM in the XEVMPD, the MAH should refer to the XEVPRM
Acknowledgment to check it the performed action has been successful.

The below business processes describe how to:

• notify changes to the pharmacovigilance system information;

• notify a PSMFL entity as 'non-current'.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 171/200
Process map 7 – Change of PSMF information

START
A change in the PhV system information must be notified in the
Article 57 database by the MAH

1.1. Retrieve the PSMFL entity EV Code and yes 1.

perform an ‘Update (2)’ to amend the location Has only the location of the existing PSMF
information as required changed?

no

1.2. Submit the XEVPRM in the XEVMPD and 2.If the PhV system changed, ‘Insert (1’) a
await the XEVPRM Acknowledgment new PSMFL entity in the XEVMPD; a new
EV Code will be assigned

1.3.1
no
Based on the XEVPRM ACK 1.3 3. Identify the AMPs with any of the ‘Valid’
message amend the XEVPRM and Positive ACK received? MA statuses that will need to be amended
re-submit to reflect the change of PhV system

yes
4. Perform an ‘Update (2)’ of the affected
AMPs to reference the new PSMFL EV Code
END
assigned to the new PhV system
information

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
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EMA/135580/2012 Page 172/200
Process map 8 – Notifying a PSMFL entity as 'non-current'

START
MAH needs to flag a PSMFL entity as non-current in the XEVMPD because the PSMFL is
either duplicated, obsolete or was submitted in error

1. yes
Does the same PSMFL entity 1.1. Identify the PSMFL that is considered the
exist in the XEVMPD with multiple duplicate
EV Codes?

no

Continue yes 2.
with step Is the PSMFL entity referenced in any
2.1 AMPs?

no

4.1 Only the owner organisation can

nullify this MAH entity. no 3. Is your organisation
the owner of this PSMFL entity
Contact the EMA Service Desk
in the XEVMPD?
(https://support.ema.europa.eu/esc)
for further information
yes

4. Nullify the PSMFL entity by submitting

an XEVPRM with Nullification ’
assigned to the duplicated PSMFL

In the Comment (MF.11) field enter the

text: Obsolete entity or Duplicate of
MFLXXX

END

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 173/200
 A
If the PSMFL entity is referenced in B C
AMPs with any of the Valid MA If the PSMFL entity is referenced: If the PSMFL entity is referenced only in
statuses • only in AMPs with a Not-Valid MA status; END nullified AMPs
or
• only in AMPs with a Not-Valid MA status
and AMPs that are nullified
A.1 Identify the AMPs referencing the
PSMFL entity you wish to flag as non- Continue
current with step
3

A.2
A.2.1 Insert ’ a new PSMFL entity no Is the PSMFL entity you wish to
in the XEVMPD; new EV Code will be reference in the AMPs instead already
assigned available in the XEVMPD?

yes

A.3 Update ’ the AMPs to reference

the correct/current PSMFL entity

Continue
with step
2

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for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 174/200
2.4. Maintenance of an authorised medicinal product (AMP) entity

Marketing authorisation holders should notify the Agency about changes to the terms of marketing
authorisations, which require a revision information on medicinal products and the applicable
structured data elements (mandatory/mandatory with conditions) as outlined in paragraph 5 of the
Legal Notice on the Implementation of Article 57(2) of Regulation (EC) No. 726/2004 on the
Implementation of Article 57(2) of Regulation (EC) No. 726/2004.

Specifically, the following operation can be used on an AMP entity:

• operation type 'Insert' (1) must be used to notify changes to the term of the marketing
authorisation that trigger a new medicinal product record according to the criteria specified in
section 1.1. Initial submission of an authorised medicinal product (AMP) entity of this document
and that includes:

− regulatory procedures that generate new marketing authorisation number (e.g., following a
variation where the NCA issues a new marketing authorisation number),

− extension to the terms of marketing authorisation (e.g., changes to the qualitative and
quantitative composition for inclusion of new active substance/adjuvant, changes of the
strength/potency, addition of authorised/administrable pharmaceutical form and routes of
administration where the NCA issues a new marketing authorisation number),

− in the context of the marketing authorisation transfer,

- notification of the renewal of marketing authorisation where the marketing authorisation

number has been changed by the competent authority;

• operation type 'Update' (2) must be used to:

- amend medicinal product information due to variations of the marketing authorisation,

- correct erroneous data,

- notify the (lifting of) suspension of the marketing authorisation,

- notify the renewal of the marketing authorisation where the marketing authorisation number
has not been changed by the competent authorities,

- extension to the terms of the marketing authorisation; changing the route of administration
and where the NCA does not issue a new marketing authorisation number;

• operation type 'Invalidate MA' (6) must be used to:

− notify the revocation/withdrawal of the marketing authorisation,

− in the context of transfer of the marketing authorisation to retire the previously submitted
(transferred) medicinal product,

- notify the renewal of the marketing authorisation where the marketing authorisation number
has been changed by the competent authority;

• operation type 'Nullification' (4) must be used to flag any medicinal product data previously
submitted in the XEVMPD as "non-current" (e.g., duplicated entities or entities provided
erroneously).

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Process map 9 – Business processes to amend medicinal product information in the XEVMPD following a regulatory procedure

Medicinal product information needs to be amended following:

Change of QPPV/PSMFL Follow the guidance and processes described in the below listed sections of this guidance document:
2.1.1.1. Business process to notify the change of QPPV's details
2.1.1.2. Business process to notify a change of a QPPV
2.3. Maintenance of a Pharmacovigilance System Master File (PSMF) entity

Variation of marketing authorisation Follow the processes described in section 2.4.1. Variations of marketing authorisation of this guidance
document

Transfer of marketing authorisation Follow the process described in section 2.4.3. Transfer of marketing authorisation of this guidance
document

Renewal of marketing authorisation Follow the process described in section 2.4.4. Renewal of marketing authorisation of this guidance
document

Lifting of suspension of marketing Follow the process described in section 2.4.2. (Lifting of) suspension of marketing authorisation of
authorisation this guidance document

Revocation/withdrawal/expiry of Follow the process described in section

marketing authorisation 2.4.6. Revocation/withdrawal/expiry of marketing authorisation of this guidance document

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Process map 10 – Amendment of an AMP entity

The following process map describes how to amend an AMP entity in the XEVMPD to ensure that the
information within the AMP elements corresponds to the information stated in the attached SmPC:

START
Information referenced
in an AMP entry needs
to be amended

1. MAH retrieves the

AMP EV Code(s) and
performs an operation
type ‘Update’ (2)

2. Is the
2.1. Retrieve the latest No latest available SmPC
SmPC for reference attached to the AMP
entry?

Yes

3. Cross-check the
information stated in
the AMP entry against
information listed in the
SmPC and amend as
applicable

4. Is the correct No
information to be 4.1 Submit the information in
referenced already the XEVMPD using operation
available in the type ‘Insert’ (1)
XEVMPD?

Yes
Yes
5. Submit the XEVPRM
using operation type 4.2. Positive XEVPRM
Back to Step 4
‘Update’ (2) including ACK received?
the latest available
SmPC and await the
XEVPRM ACK
No

4.3. As per XEVPRM

6.1. As per XEVPRM ACK message, MAH
No
ACK message, MAH 6. Positive XEVPRM corrects the affected
corrects the affected ACK received? information
information

Yes
Continue with
Step 4.1
END

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2.4.1. Variations of marketing authorisation

Operation type 'Update' (2) must be used, as applicable, to amend incorrectly submitted information
(e.g., typos, misspellings and information submitted by mistake) and to submit the latest information
on the following product data following a variation procedure:

• (invented) name of the medicinal product;

• description of the pharmacodynamic properties (i.e., the ATC code(s) for the medicinal product);

• details of the marketing authorisation including authorisation status, authorisation country,

authorisation procedure, authorisation/renewal date and MRP/DCP/EMEA and EU numbers (i.e., to
amend incorrectly submitted information);

• marketing authorisation legal basis;

• orphan drug designation;

• medicinal product type as described in section 1.2.12.14. Medicinal product types (AP.12.MPT.1) of
this document;

• therapeutic indications coded in MedDRA and declaration that the medicinal product is "Authorised
for the treatment in children";

• description of the excipient(s);

• description of active substance(s) and adjuvant(s) (i.e., to amend incorrectly submitted

information or to reflect a different description of the substance name);

− Please note that change to the active ingredients and adjuvant refers to line extension and
should be notified with an operation type 'Insert' (1);

• description of the strength (amount) of the active substance(s) and adjuvant(s) (i.e., to amend
incorrectly submitted information);

− Please note that change of the strength/potency refers to line extension and should be notified
with an operation type 'Insert' (1).

• medical device(s) for combined advanced therapy medicinal product (i.e., in accordance with
Regulation (EC) No 1394/2007);

• authorised and administrable pharmaceutical form(s) (i.e., to amend incorrectly submitted

information);

− Please note that change of the authorised and administrable pharmaceutical form(s) refers to
line extension and should be notified with an operation type 'Insert' (1).

• route(s) of administration (i.e., to amend incorrectly submitted information);

− Please note that change of the Route(s) of administration refers to line extension and should
be notified with an operation type 'Insert' (1).

• name of qualified person responsible for pharmacovigilance (QPPV);

• location of the pharmacovigilance system master file (PSMF);

• contact information for pharmacovigilance enquiries;

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• latest approved SmPC where variations are leading to significant content revision of the following
sections of the electronic document and with no impact on XEVPRM structured data elements
(mandatory/mandatory with conditions)section 4.1 Therapeutic indications which do not have a
direct impact on the MedDRA coding of the indication,

− section 4.2 Posology and method of administration (other than route of administration),

− section 4.3 Contraindications,

− section 4.4 Special warnings and precautions for use,

− section 4.5 Interaction with other medicinal products and other forms of interaction,

− section 4.6 Fertility, Pregnancy and lactation,

− section 4.8 Undesirable effects,

− section 4.9 Overdose;

Significant revisions to these sections are defined as revisions which affect the scientific meaning or
information being communicated and does not include minor rephrasing or re ordering due to, for
example, a QRD update.

• to correct marketing authorisation holder information (i.e., to amend incorrectly submitted

information);

− Please note that change of the marketing authorisation holder should be notified as transfer of
marketing authorisation and therefore the business process outlined in section 2.4.3. Transfer
of marketing authorisation of this document.

• (Lifting of) suspension of marketing authorisation;

• notification of the renewal of marketing authorisation where the authorisation number has not
been changed by the competent authority (please refer to section 2.4.4.1. Business process -
Authorisation number has not changed following a renewal of this document).

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EXAMPLES of submission dates for variations:

Submission date for Type IA Variations ('Do and Tell') excluding the notification of changes
to the QPPV and PSMFL3

Submission date for Type IB Variations

3
Notification of changes related to the QPPV/PSFML are described in sections and 2.3.

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Submission date for Type II Variations

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Submission date for Type II Variations (MRP/DCP)

Submission date for Type II Variations (NAP)

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2.4.1.1. Business process - Authorisation number has changed following a variation

The same business process as described in section 2.4.4.2. Business process - Authorisation number
has changed following a renewal should be followed when authorisation number changes following a
variation procedure. I.e.:

• the MAH must retire the authorised medicinal product for which the marketing authorisation
number is no longer valid by using the operation type 'Invalidate MA' (6);

• in the retired AMP entity:

− the value "Not Valid – Superseded by Marketing Authorisation Renewal/Variation" (10) must be
specified in the data element "Authorisation status" (AP.12.3);

• a new AMP entity must be submitted in the XEVMPD using the operation type 'Insert' (1) with:

− the new valid authorisation number specified in data element "Authorisation number"
(AP.12.4),

− the value "Valid – Renewed/Varied Marketing Authorisation" (8) must be specified in the data
element "Authorisation status" (AP.12.3),

− the authorisation date as referenced in the applicable attachment must be specified in the data
element "Authorisation/renewal date" (AP.12.5),

− the EV code of the previously submitted AMP entity for which the marketing authorisation
number has changed after the variation must be referenced in the XEVPRM section "Previous
EV Code" (AP.PEV). The EV Code of the AMP referenced in the "Previous EV Code" (AP.PEV)
field must not be a nullified EV Code.

If the variation occurred after a renewal of marketing authorisation and the marketing authorisation
number did change following the variation, the same process and principles described above apply.

2.4.1.2. Business process - Authorisation number has not changed following a variation

The MAH retrieves the AMP (based on the assigned EV code) for which the marketing authorisation has
been varied and, using an operation type 'Update (2)', amends the medicinal product entity to reflect
the changes following the variation (e.g., change of medicinal product name, new indication etc.).

• the authorisation number remains unchanged;

• the authorisation status remains unchanged;

• the authorisation/renewal date remains unchanged.

The MAH checks the XEVPRM ACK to ensure that the AMPs have been updated successfully.

If the variation occurred after a renewal of marketing authorisation and the marketing authorisation
number did not change following the variation, the same process and principles described above apply.

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2.4.2. (Lifting of) suspension of marketing authorisation

Operation type 'Update' (2) must be used to notify the suspension of the marketing authorisation or
the lifting of suspension of marketing authorisation.

In case of notification of suspension of marketing authorisation, the following information must be

provided:

• date of the suspension must be specified in the data element "Invalidated date" (AP.12.12);

− the value "Valid – Suspended" (2) must be specified in the data element "Authorisation status"
(AP.12.3) before submitting the XEVPRM.

In case of notification of lifting of suspension of a marketing authorisation, the following

information must be provided:

• no date must be specified in "Invalidated date" (AP.12.12) – this field must be left blank;

• date of lifting of the suspension must be specified in the data element "Info date" (AP.11);

• the data element "Authorisation status" (AP.12.3) must continue any other value except "Valid –
Suspended" (2) before submitting the XEVPRM.

MAH must check the XEVPRM ACK to ensure that the medicinal product information has been amended
(updated) successfully.

2.4.3. Transfer of marketing authorisation

The notification of the transfer of marketing authorisation (i.e., change of the Legal entity of the
medicinal product) from the "former MAH" to the "new MAH" is described in this section.

MAH organisations established in the UK should also note sections 4 and 5 of the 'Commission Notice –
Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply
from or through parts of the United Kingdom other than Northern Ireland' and information in
DIRECTIVE (EU) 2022/642 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 April 2022
amending Directives 2001/20/EC and 2001/83/EC as regards derogations from certain obligations
concerning certain medicinal products for human use made available in the United Kingdom in respect
of Northern Ireland and in Cyprus, Ireland and Malta.

2.4.3.1. Transfer of marketing authorisation between organisations registered in

EudraVigilance under separate headquarters

The "former MAH" must retrieve the existing AMP(s) based on the assigned EV code(s) for which the
marketing authorisation was transferred and retire the transferred medicinal product entry/entries by
using the operation type "Invalidate MA" (6);

• the value 'Not Valid – Superseded by Marketing Authorisation Transfer' (11) must be specified in
the data element 'Authorisation status' (AP.12.3);

• the date of transfer must be specified in the data element 'Invalidated date' (AP.12.12).

• from January 2025, the MAH referenced in the data element 'MAH' (AP.4) must be changed to
reference the new MAH organisation instead of the former MAH organisation. This will allow the

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 former MAH to indicate who is the new MAH of the medicinal product and support PMS
implementation.

− The former MAH can search for the new MAH entity in the 'MAH' look-up table available in
EVWEB or retrieve the EV Code of the new MAH in OMS, in the 'Mappings' section of the
relevant organisation.

− If the former MAH is unable to identify the EV Code of the new MAH or if no EV Code of the
new MAH is available, the former MAH should liaise with the new MAH to request the
information.

• The "former MAH" checks the XEVPRM Acknowledgment (ACK) to make sure that the AMP has been
invalidated successfully.

The "new MAH" must submit new AMP entity for the acquired medicinal products by using the
operation type 'Insert' (1) and;

− the value "Valid – Transferred Marketing Authorisation" (9) must be specified in the data
element "Authorisation status" (AP.12.3);

− the date of granting of marketing authorisation by the competent authority must be specified
in the data element "Authorisation date" (AP.12.5);

− the EV Code of the AMP entity submitted in the XEVMPD by the former MAH (communicated by
the former MAH) must be referenced in XEVPRM section "Previous EV Code" (AP.PEV). The EV
Code of the AMP referenced in the "Previous EV Code" (AP.PEV) field must not be a nullified EV
Code.

a) In case the former MAH was not compliant with the Article 57 requirements and therefore
there is no AMP in the XEVMPD to be referenced (i.e., no previous EV Code was assigned)
or the previous MAH nullified the EV Code before the new MAH referenced in in their new AMP
record, the new MAH can submit the transferred AMP with the 'Insert' (01) operation type and
enter value "Valid" (1) in the data element "Authorisation status" (AP.12.3),

b) in case the former MAH did not provide the new MAH with the EV Code of the AMP
as entered by the former MAH, please contact the EMA Service desk to request the EV Code.
Please provide the medicinal product name(s), the name of the former MAH organisation and,
if known, the MAH's EV Code, and the authorisation number(s) of the medicinal product(s) as
assigned to the previous MAH. Based on the specified information, the EMA will retrieve the
AMP and provide you with the EV Code if available in the XEVMPD.

The new MAH must check the XEVPRM Acknowledgement (ACK) to make sure that the new AMP has
been inserted successfully.

EXAMPLE:

"Pharma A" is the former MAH of Product X for which the marketing authorisation was transferred to
"Pharma C". Both MAHs are registered in EudraVigilance under their own HQ IDs:

1. "Pharma A" performs an invalidation of their AMP record to refence:

a. 'Not Valid – Superseded by Marketing Authorisation Transfer' as the authorisation

status,

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 b. the date of transfer in the 'Invalidated date' element and

c. the EV Code assigned to "Pharma C" in the XEVMPD as the marketing authorisation
holder.

2. "Pharma C" inserts new AMP record in the Article 57 database, referencing

a. 'Valid – Transferred Marketing Authorisation' as the authorisation status,

b. the date of granting of the marketing authorisation by the competent authority in the
'Authorisation date' element;

c. The EV Code assigned to "Pharma C" in the XEVMPD as the marketing authorisation
holder in the 'MAH' data element,

d. the EV Code of the AMP entity submitted in the XEVMPD by the former MAH
(communicated by the former MAH or EMA) in the 'Previous EV Code' section.

2.4.3.2. Transfer of marketing authorisation between organisations registered in

EudraVigilance under the same headquarter

For MA transfers within the same organisation (i.e.: organisations under the same EV
headquarter), where product data ownership and further maintenance in the XEVMPD is not affected
by the marketing authorisation transfer, a simplified process may be followed:

• retrieve the AMP (based on the assigned EV code) for which the marketing authorisation was
transferred and apply an operation type 'Update (2)';

• enter the value "Valid – Transferred Marketing Authorisation (9)" in the data element
"Authorisation status" (AP.12.3);

• in the data element "Marketing authorisation holder (MAH) code (AP.4)" reference the EV code of
the new MAH;

• in the "Previous EV Code" (AP.PEV) section enter the EV Code of the product entity that you are
updating;

• submit the XEVPRM and check the XEVPRM Acknowledgement (ACK) to make sure that the AMP
information was successfully updated.

EXAMPLES:

1. "Pharma A" is an MAH established in Ireland. "Pharma B", which is established in Germany, is
registered in EV as an affiliate under the HQ of "Pharma A". Since "Pharma B" is in EV
registered under the HQ of "Pharma A" the transfer of MA from "Pharma A" to "Pharma B" may
be notified using the simplified process described above.

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 2. "Pharma C" is an MAH established in the Germany. "Pharma D" is an MAH established in
France. Both organisations are registered in EV as affiliates under the HQ of "Pharma E". Since
both MAHs are registered in EV under the same HQ the transfer of MA from "Pharma C" to
"Pharma D" may be notified using the simplified process described above.

Both processes to notify the transfer of marketing authorisation are described below:

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Process map 11 – Transfer of marketing authorisation

Between organisations registered in EV under separate headquarters:

START START
The former MAH must notify a transfer of The new MAH must notify a transfer of
MA to a new MAH in the XEVMPD MA in the XEMPD

1.1 Contact the EMA Service Desk to

1. Identify the EV Code of the AMP for which request the EV Code
the MA was transferred in the XEVMPD
1. no Provide the following details of the AMP for
Did you receive the EV Code of which you re requesting the EV Code:
the AMP invalidated by the - the medicinal product name(s)
2. Perform an Invalidate MA ’ operation former MAH? - the name of the former MAH organisation
on the EV Code and the MAH's EV Code
- the authorisation number of the AMP
The authorisation status must be set to Not - the authorisation country
yes
Valid - Superseded by Marketing
Authorisation Transfer ’ Insert a new AMP entity in the
XEVMPD
The Invalidated date (AP.12.12) must be
populated 1.2
The authorisation status must be set to Valid yes Did you receive the EV Code
– Transferred Marketing Authorisation ’
The new MAH must be referenced of the AMP as entered in the
XEVMPD by the former MAH?
Enter the EV Code of the AMP invalidated by
the former MAH in the Previous EV Code
3. Submit the XEVPRM with Invalidate MA (AP.PEV) section
’ in the XEVMPD no

Insert ’ a new AMP entity in the

3.1 As per the XEVPRM no 3. XEVMPD
ACK message, amend the Positive XEVPRM ACK received?
4.1 As per the XEVPRM ACK no 4. AMP information The authorisation status must be set to
message, amend the AMP Positive XEVPRM ACK received? Valid ’
information
yes

yes
END

5.Communicate the invalidated AMP EV Code

to the new MAH

END

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Within the same organisation (i.e., organisations under the same EV headquarter):

START
MAH wishes to notify to the Agency an MA transfer within the same
organisation (i.e.: the ‘former’ MAH and the ‘new’ MAH organisations are
both registered in EV under the same EV headquarter)

1. Identify the EV Code of the AMP for which

the MA was transferred in the XEVMPD

2. Perform an ‘Update (2)’ operation on the

EV Code

The authorisation status must be set to

‘Valid – Transferred Marketing Authorisation
(9)’

3. Enter the new MAH in the ‘MAH’ data

element

4. Enter the EV Code of the AMP that you are

updating in the ‘Previous EV Code’ section of
the AMP

5. Submit the XEVPRM with ‘Update (2)’ in

the XEVMPD

6.1 As per the XEVPRM ACK no 6.

message, amend the AMP Positive XEVPRM ACK received?
information

yes

END

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2.4.4. Renewal of marketing authorisation

2.4.4.1. Business process - Authorisation number has not changed following a renewal

As outlined in section of this document, notifications of renewal of marketing authorisations where the
marketing authorisation number has not been changed by the competent authority must be notified
with the operation type 'Update' (2).

The MAH retrieves the AMP (based on the assigned EV code) for which the marketing authorisation has
been renewed and changes the date of authorisation for the date of renewal in the data element
"Authorisation/renewal date" (AP.12.5).

The MAH checks the XEVPRM ACK to ensure that the AMPs have been updated successfully.

2.4.4.2. Business process - Authorisation number has changed following a renewal

Notifications of renewal of marketing authorisations where the marketing authorisation number has
been changed by the competent authorities is to be performed as follows:

• the MAH must retire the authorised medicinal product for which the marketing authorisation
number is no longer valid by using the operation type 'Invalidate MA' (6);

• in the retired AMP entity:

− the value "Not Valid – Superseded by Marketing Authorisation Renewal/Variation" (10) must be
specified in the data element "Authorisation status" (AP.12.3),

− the date of renewal must be specified in the data element "Invalidated date" (AP.12.12);

• a new AMP entity must be submitted in the XEVMPD using the operation type 'Insert' (1) with:

− the new valid authorisation number specified in data element "Authorisation number"
(AP.12.4),

− the value "Valid – Renewed/Varied Marketing Authorisation" (8) must be specified in the data
element "Authorisation status" (AP.12.3),

− the date of the renewal must be specified in the data element "Authorisation/renewal date"
(AP.12.5),

− the EV code of the previously submitted AMP entity for which the marketing authorisation
number has changed must be referenced in XEVPRM section "Previous EV Code" (AP.PEV). The
EV Code of the AMP referenced in the "Previous EV Code" (AP.PEV) field must not be a nullified
EV Code.

The MAH checks the XEVPRM Acknowledgement (ACK) to ensure the successful renewal of the AMP.

Overall renewal of marketing authorisation process is described below.

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Process map 12 – Renewal of marketing authorisation

START
A need to notify a renewal
of MA is identified

1. Based on the assigned EV Code, the

MAH retrieves the AMP entry
for which the MA is renewed

No 2.1 Using the operation type No

2. Did the authorisation 2.2 2.3 As per XEVPRM ACK
‘Update’ (2) replace the
number change following Positive XEVPRM message, MAH corrects
authorisation date with the renewal
the renewal? ACK received? the affected information
date and submit the XEVPRM

Yes Yes

3. MAH invalidates the AMP entry using END

operation type ‘Invalidate MA’ (6).
Authorisation status
‘Not Valid – Superseded by Marketing
Authorisation Renewal/Variation’ (10)
must be specified

4. MAH submits the XEVPRM

and awaits the XEVPRM ACK

5. No
Positive XEVPRM 5.1 As per XEVPRM ACK
ACK received? message, MAH corrects
the affected information

Yes

6. Using operation type ‘Insert’ (1)

MAH submits a new AMP entry.
8. No
Authorisation status 8.1 As per XEVPRM ACK
7. MAH submits the XEVPRM Positive XEVPRM
‘Valid – Renewed/Varied Marketing message, MAH corrects
and awaits the XEVPRM ACK ACK received?
Authorisation’ (8) must be used and the affected information
the previous EV Code must be
referenced Yes

END

2.4.5. Change of authorisation procedure following a referral

If authorisation procedure has changed from "National" to "MRP" following referral and the marketing
authorisation number did not change, marketing authorisation holder retrieves the AMP (based on the
assigned EV code) and using operation type 'Update (2)', amends the AMP entity:

• the Authorisation procedure 'EU authorisation procedures – Mutual recognition procedure (3)' must
be specified in the "Authorisation Procedure" field (AP.12.2);

• the MR number must be specified in the "MRP/DCP/EMEA number" field (AP.12.7).

2.4.6. Revocation/withdrawal/expiry of marketing authorisation

Operation type 'Invalidate MA' (6) must be used to notify the revocation/withdrawal/expiry of
marketing authorisation:

• the date of revocation or withdrawal or expiry must be specified in the data element "Invalidated
date" (AP.12.12);

• one of the "Not Valid" statuses must be specified (as applicable) in the data element "Authorisation
status" (AP.12.3) before sending the XEVPRM.

The MAH checks the XEVPRM ACK to ensure that the AMP has been invalidated successfully.

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2.4.7. Nullification of AMP entities

Marketing authorisation holders should flag as "nullified" AMP entities created by mistake, e.g.,
duplicated entities (the same medicinal product information was submitted multiple times, multiple EV
Codes were assigned) or entities provided erroneously (e.g., they were not supposed to be submitted).

Only the owner of the product data in the XEVMPD (i.e., the organisation that submitted the data
and/or its HQ) can nullify such data.

− From 18 January 2024, only the EMA can nullify proposed and standard terms in the XEVMPD.

• Nullification is not allowed on AMP entities, which are considered legacy product data submitted in
the XEVMPD in the pre-Article 57 format. Such product entities should not be maintained by the
MAH.

• Nullification is not allowed on AMP entities which were flagged as "Valid" in the XEVMPD (i.e., the
"Product Validity" field displays the value "Valid") following a quality control check by the Agency
[see Quality control of medicinal-product data submitted as per the legal requirement introduced
by Article 57(2) of Regulation (EC) No 726/2004 for related information].

Only the EMA can nullify such AMP entities. Please submit a nullification request using the EMA
Service Desk portal, stating the EV Code(s) of the AMP(s) you wish to nullify, your organisation's
name and EudraVigilance registration ID, and the reason for nullification.

Since all AMP entities flagged as "Valid" are used to support signal management activities (e.g.,
codification of ICSRs), before they are nullified, the EMA needs to check that a "substitute" record
is available in the XEVMPD. If the reason for nullification is due to duplication, the EV Code of the
AMP entity that the MAH will be maintaining in the XEVMPD must also be provided as part of the
nullification request. If a nullification of more than 10 AMP entities is requested, please provide the
EV Codes in an Excel spreadsheet.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 193/200
Process map 13 – Nullification of an AMP entity

START
An AMP entity needs to be nullified in the XEVMPD

1. No
Only the owner organisation can perform the nullification.
Are you considered the owner of
If you require further information about the AMP entity please
this AMP entity in the XEVMPD?
submit an enquiry via the EMA Service Desk portal

yes

yes
2. The AMP is exempt from maintenance responsibilities of the
Is the AMP entity considered a MAH organisation.
Legacy product data You do not need to perform any action on this AMP entity.

No

If you provided this EV Code to the new MAH as part of the

transfer of MA process
3. yes - You should contact the new MAH and provide them with a
Was the EV Code subject to
new EV Code to reference in the Previous EV Code section
an MA transfer (i.e. is the EV Code
instead so that the EV Code you wish to nullify is no longer
referencing a Not-Valid MA
referenced in their AMP
status)?
- Only when the EV Code you wish to nullify is not referenced
in any other AMP entities the nullification can be performed.

No
Request the nullification via the EMA Service Desk Portal.
yes Include the EV Code of the AMP, MAH s name and EV
4. Registration ID, and the reason for nullification.
Is this AMP flagged as Valid in the If the reason for nullification is due to a duplication, provide in
XEVMPD? your nullification request
also the EV Code of the AMP entity that you will be
maintaining in the XEVMPD.
No

5. Submit an XEVPRM with operation type

Nullification ’ in the XEVMPD and await
the XEVPRM ACK

No
6.1 As per XEVPRM ACK message, correct
6.
the affected information in you original
Positive XEVPRM ACK received?
XEVPRM

yes

END

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 194/200
2.5. Nullification of XEVMPD entities

An XEVMPD entity, which is duplicated (i.e., multiple EV Codes are assigned to the same entity),
obsolete (the entity is not/will not be referenced in any product submissions) or erroneously submitted
(e.g., the entity was not supposed to be submitted) can be flagged as 'non-current' by submitting an
XEVPRM with the operation type 'Nullification' (4).

Standard and proposed terms (ATC Codes, pharmaceutical forms, routes of administration) can only be
nullified by the EMA.

In general, MAHs may nullify entities owned in the XEVMPD by their HQ organisation. MAHs can
therefore nullify:

• AMP entities;

• MAH entities;

• PSMFL entities.

There are however restrictions related to the nullification of entities referenced in other entities.

The above listed entities may be nullified by their owner organisations only if they are:

• Not referenced in any other XEVMPD entities (e.g.: AMPs) or they are only referenced in
XEVMPD entities that are nullified.

− If the entity you wish to nullify is referenced in not-nullified AMPs with any of the 'Valid'
marketing authorisation statuses, the AMPs must first be updated to reference another
entity before the nullification is technically possible.

− If the entity you wish to nullify is referenced in not-nullified AMPs that were invalidated
[i.e., the 'Authorisation status (AP.12.3)' field references any of the 'Not-valid' values], the
AMPs will need to be amended by the EMA to reference another entity before the nullification is
technically possible.

See the Process Map 14 below for details.

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 195/200
Process map 14 – Nullification of XEVMPD entities

START
An XEVMPD entity needs to
be nullified in the XEVMPD

1. Only the owner organisation can perform the nullification.

Does your organisation own the No If you require further information please submit a Request for
entity in the XEVMPD? Information via the EMA Service Desk portal

Yes

Please refer to the below sections for specific guidance:

2.
Process map 13 – Nullification of an AMP entity
Is the entity to be nullified an AMP, Yes
Process map 6 – Notifying an MAH entity as 'non-current'
MAH or PSMFL entity?
Process map 8 – Notifying a PSMFL entity as 'non-current'

No

Only the EMA can nullify approved substance providing that they are
3.
not referenced in any current product entities.
Is the entity to be nullified an Yes
Please request the nullification via the EMA Service Desk portal using
approved substance?
the Request SMS services form

No

From 18 January 2024 proposed and standard terms can be nullified

4.
only by the EMA providing that they are not referenced in any current
Is the entity to be nullified a
Yes product entities.
proposed or standard term?
Please request the nullification via the EMA Service Desk portal using
the Request XEVMPD/Art.57 Services form

No

The AMP will need to be amended, so that the entity to be

5.
nullified is no longer referenced in the latest version of the AMP.
Is the entity to be nullified
The amendment can be performed by the MAH organisation
Yes referenced in the latest version of
that owns the AMP record in the XEVMPD and/or by the EMA
any current AMP
upon request via the EMA Service Desk portal using the
entity?
Request XEVMPD/Art.57 Services form

No

6.
Request the nuliifcation via the EMA Service Desk portal using
Yes Is the entity you wish to nullify
the Request XEVMPD/Art.57 Services form
validated by the EMA?

No

7. Perform the nullification by submitting

an XEVPRM with operation type NULLIFY
assigned to the EV Code of the entity
you wish to nullify

8.1 Based on the XEVPRM ACK operation result,

8.
No correct the information as required and re-submit the
Positive XEVPRM ACK received?
XEVPRM

Yes

END

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 196/200
Annex I: Pack size submissions

Submit all authorised pack sizes

YES Package description is optional
but recomended

Submit all authorised pack sizes

Is it a CAP? YES Package description is optional
but recomended

NO Is it a non-CAP
authorised at pack
YES Submit at least all marketed pack sizes
size level? YES Package description is mandatory

NO
Is the ATC Code in the
ULCM?
Submission at pack size level is
NO
optional
New authorised
START
medicinal product?

All pack sizes should be

already in XEVMPD
NO YES

By 31 January 2025:

• Update the current AMP record with the lowest pack size
Is it a CAP or non-CAP
YES • Insert AMP records for new pack sizes
authorised at pack size
• Package description is mandatory
level?

NO

Is the ATC Code in the

ULCM?

NO
No need to submit separate pack sizes

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 197/200
Annex II: XEVMPD submission contact points
Support related to submission of information in the XEVMPD is provided via the EMA Service desk.

• Request (for) XEVMPD/Art.57 Services should be submitted to request:

− XEVMPD data, such as:

an EV Code of an AMP to support a notification of a transfer or marketing authorisation

between organisations registered under different EV HQs,

a copy of the XEVPRM ACK if not received by the MAH.

− Support with XEVMPD data management, such as:

nullification of validated entries,

data amendment of data in the XEVMPD on behalf of the MAH organisation, e.g. a correction of
information in invalidated AMPs, change of authorisation status of an AMP record back to valid
in case of incorrect invalidation of the AMP entity,

data correction in case the MAH does not agree with the change(s) made as part of the
validation the AMP performed by EMA data stewards.

− Registration for XEVMPD e-learning training, e.g.:

initial registration for the knowledge evaluation,

assessment of knowledge evaluation.

The timeframe applicable to the XEVMPD support team/EMA data stewards to address such request is
5 working days since the ticket was assigned to the XEVMPD support team.

• Request for information referencing "SPOR" as the 'Service' and "XEVMPD/Art.57" as the
'Service Offering' should be submitted to request information or ask a question related to:

− XEVMPD processes in use;

− guidance on how to submit data in XEVMPD;

− where to find XEVMPD related information;

− how to use XEVMPD Data entry tool;

− XEVMPD e-learning training process (questions related to the initial registration,

assessment evaluation, access to XCOMP for e-learning training purposes).

The timeframe applicable to the XEVMPD support team to respond to such request is 22 working
days since the ticket was assigned to the XEVMPD support team.

• Report (of) a technical issue with XEVMPD/Art.57 should be submitted to notify the EMA of a
technical issue with:

− XEVMPD (production or XCOMP environment);

− XEVMPD additional tools (e.g., XEVMPD Data Export tool, XEVMPD Bulk update tool);

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 199/200
 − Gateway submissions to XEVMPD.

The timeframe applicable to the responsible team to respond to such report is 5 working days since
the ticket was assigned to the responsible team IT or XEVMPD support team).

Detailed guidance on the electronic submission of information on medicinal products

for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 200/200