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International Cooperation on Harmonization of Technical

Requirements for Registration of Veterinary Medicinal Products

(VICH)

Electronic Submission of Animal Adverse Events

Electronic Transmission Implementation Specifications

VICH Step By Step Document
Version: 1.0.2

November 05, 2014

The contents within this document are based on ISO 27953-1.

VICH Step by Step Document

Document Change Record

Version Number Date Description
V 1.0.0 June 28, 2012 Final Draft
V.1.0.0 August 02, 2012 Final (includes feedback)
V.1.0.1 August 8, 2013 FDA CVM Proposed Changes
V.1.0.2 November 5, 2014 Corrected definition of A.4.2 Original Receive
Date to correspond with GL42 definition

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VICH Step by Step Document

Table of Contents
1 Introduction ........................................................................................................................................ 1-1
1.1 VICH GL42 ........................................................................................................................................ 1-1
1.2 AER Documents ................................................................................................................................ 1-1
1.3 Document Structure........................................................................................................................... 1-2
1.4 Structure of AER Submission Message ............................................................................................ 1-2
1.5 Exceptions to Be Noted ..................................................................................................................... 1-4
1.6 Special Handling of Element Fields (Null Flavors) ............................................................................ 1-5
1.7 XML Locator Codes ........................................................................................................................... 1-7
1.8 Rules Concerning Handling Responses Within Elements ................................................................ 1-8
1.9 Vocabulary Reference List of Values ................................................................................................ 1-8
1.10 MAH to RA Message ......................................................................................................................... 1-8
1.11 Disclaimer .......................................................................................................................................... 1-8
2 Administrative and Identification Information – GL42 Section A ....................................................... 2-1
2.1 Regulatory Authority (RA) – GL42 Section A.1 (A.1.1 – A.1.6) ......................................................... 2-1
2.2 Marketing Authorization Holder (MAH) (Sender) – GL42 Section A.2 (A.2.1 - A.2.2.6) ................... 2-2
2.3 Person(s) Involved in AER (Reporter) – GL42 Section A.3 (A.3.1 – A.3.2.12) ................................. 2-4
2.4 AER Information (Investigation/Report Information) – GL42 Section A.4 (A.4.1 – A.4.4.3).............. 2-5
2.4.1 Unique Adverse Event Report Identification Number – GL42 Section A.4.1 ....................... 2-5
2.4.2 Original Receive Date – GL42 Section A.4.2 ....................................................................... 2-6
2.4.3 Date of Current Submission – GL42 Section A.4.3 .............................................................. 2-7
2.4.4 Type of Report – GL42 Section A.4.4 .................................................................................. 2-7
3 Description of AE – GL42 Section B ................................................................................................. 3-1
3.1 Animal Data – GL42 Section B.1 (B.1.1 – B.1.9.3.1) ........................................................................ 3-1
3.1.1 Number of Animals Treated – GL42 Section B.1.1 .............................................................. 3-1
3.1.2 Number of Animals Affected – GL42 Section B.1.2 ............................................................. 3-1
3.1.3 Species – GL42 Section B.1.3 ............................................................................................. 3-3
3.1.4 Breed (Breed Group) – GL42 Section B.1.4 ........................................................................ 3-3
3.1.5 Gender, Reproductive Status, and Female Physiological Status – GL42 Section B.1.5 -
B.1.7 3-9
3.1.6 Weight & Age – GL42 Section B.1.8 and B.1.9 .................................................................. 3-10
3.2 VMP(s) Data and Usage – GL42 Section B.2 (B.2.1 – B.2.6.5) ...................................................... 3-12
3.2.1 Registered or Brand Name – GL42 Section B.2.1 ............................................................. 3-12
3.2.2 Active Ingredient(s) – GL42 Section B.2.2 ......................................................................... 3-27
3.2.3 Lot Number and Expiration Date – GL42 Section B.2.3, B.2.3.1 ....................................... 3-30
3.2.4 Who Administered the VMP (Administered or Performed by) – GL42 Section B.2.4 ........ 3-31
3.2.5 Use According to Label – GL42 Section B.2.5 ................................................................... 3-32
3.3 Adverse Event Data – GL42 Section B.3 (B.3.1 – B.3.10) .............................................................. 3-34
3.3.1 Narrative of AE – GL42 Section B.3.1 ................................................................................ 3-34
3.3.2 Adverse Clinical Manifestations (AER Term Name) – GL42 Section B.3.2 ....................... 3-35
3.3.3 Date of Onset of AE (AE Start Date) – GL42 Section B.3.3 .............................................. 3-36
3.3.4 Length of Time between Exposure to VMP and Onset of AE – GL42 Section B.3.4......... 3-37
3.3.5 Duration of AE – GL42 Section B.3.5, B.3.5.1, B.3.5.1.1 ................................................... 3-38
3.3.6 Serious AER (Serious AE as Reported) – GL42 Section B.3.6 ......................................... 3-39
3.3.7 Treatment of AE – GL42 Section B.3.7 .............................................................................. 3-39
3.3.8 Outcomes to Date – GL42 Section B.3.8 (B.3.8.1 – B.3.8.6) ............................................. 3-39
3.3.9 Previous Exposure to the VMP – GL42 Section B.3.9 ....................................................... 3-41
3.3.10 Previous AE to VMP – GL42 Section B.3.10 ..................................................................... 3-41
3.4 Dechallenge - Rechallenge Information – GL42 Section B.4 (B.4.1 – B.4.2) ................................. 3-42
3.4.1 Did AE Abate After Stopping the VMP – GL42 Section B.4.1 ............................................ 3-42
3.4.2 Did AE Reappear After Re-introduction of the VMP – GL42 Section B.4.2 ....................... 3-42
3.5 Assessment of AE – GL42 Section B.5 ........................................................................................... 3-43
3.6 Report Number(s) of Linked Report(s) – Section GL42 B.6 (B.6.1 – B.6.1.1) ................................ 3-44
3.7 Supplemental Documents – Section GL42 B.7 ............................................................................... 3-45
3.7.1 Attached Document Filename – GL42 Section B.7.1......................................................... 3-45

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3.7.2 Attached Document Type – GL42 Section B.7.1.1 ............................................................ 3-45

3.7.3 Supplemental Document Data ........................................................................................... 3-46
4 AER Wrapper Information ................................................................................................................. 4-1
4.1 Batch Wrapper (Section B.8.1 – B.8.1.6) .......................................................................................... 4-1
4.1.1 Batch Number/Identifier (B.8.1.1.1 – B.8.1.1.2) ................................................................... 4-1
4.1.2 Batch Sender (B.8.1.2.1 – B.8.1.2.8) ................................................................................... 4-1
4.1.3 Batch Receiver (B.8.1.3.1 – B.8.1.3.2) ................................................................................. 4-2
4.1.4 Date of Batch Creation (B.8.1.4) .......................................................................................... 4-3
4.1.5 VICH AER Version Number (B.8.1.5) .................................................................................. 4-3
4.2 Transmission Wrapper (Section B.8.2 – B.8.2.8) .............................................................................. 4-4
4.2.1 Message Number (B.8.2.1.1 – B.8.2.1.2) ............................................................................. 4-4
4.2.2 Message Sender (B.8.2.2.1 - B.8.2.2.8) ............................................................................... 4-4
4.2.3 Message Receiver (B.8.2.3 – B.8.2.3.1) .............................................................................. 4-5
4.2.4 Date of Message Creation (B.8.2.4) ..................................................................................... 4-6
4.2.5 Report Identifier (B.8.2.5) ..................................................................................................... 4-6
4.2.6 Domestic vs. Foreign Report Category (B.8.2.6) ................................................................. 4-7
4.2.7 Profile Identifier (B.8.2.7) ...................................................................................................... 4-8
5 List of Abbreviations .......................................................................................................................... 5-1
6 RA to MAH, RA to RA, and MAH to MAH Snippets .......................................................................... 6-1

List of Figures
Figure 1-1 Sample AER Submission Format ......................................................................................... 1-2
Figure 1-2 Sample XML AER Batch Submission .................................................................................. 1-4

List of Tables
Table 1-1 AER Documents ...................................................................................................................... 1-1
Table 1-2 Null Flavor Element Data Rules ............................................................................................. 1-6
Table 1-3 XML Locator Codes ................................................................................................................. 1-7
Table 2-1 Regulatory Authority Information .......................................................................................... 2-1
Table 2-2 Telecom Entry Format Rules .................................................................................................. 2-3
Table 3-1 Usage of Sample Drug 1 ....................................................................................................... 3-23
Table 3-2 Usage of Sample Drug 2 ....................................................................................................... 3-23

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1 Introduction
The purpose of this document is to provide step by step directions to assist users, reporters,
and technical staff in completing a well formed Veterinary Medicinal Product (VMP) Adverse
Event Reports (AER) message that is compliant with the ISO 27953-1 schema.

1.1 VICH GL42

The International Cooperation on Harmonization of Technical Requirements for Registration of
Veterinary Medicinal Products (VICH) has established a standard set of definitions to describe
the data elements that need to be submitted for compliant adverse event reports (AERs). These
data elements can be found in VICH GL42. This document provides a translation and mapping
of GL42 compliant adverse event report’s data elements into the ISO 27953-1 version XML
message.

This document describes Marketing Authorization Holder (MAH) to Regulatory Authority (RA)
message. Section 6 of this document also provides examples for RA to RA, RA to MAH, and
MAH to MAH messages. MAHs will send a message compliant with the RA systems, adherent
to GL35, this document and the relevant Regional Annexes.

1.2 AER Documents

The VICH has generated a number of documents to assist stakeholders in preparing, formatting
and transmitting electronic submissions of AERs. The following table lists the documents.

Table 1-1 AER Documents

Title Description
VICH GL42 - PHARMACOVIGILANCE OF Establishes a standard set of definitions
VETERINARY MEDICINAL PRODUCTS: Data to describe the data elements that need
Elements for Submission of Adverse Event to be submitted for compliant adverse
Reports (AERS) event reports
VICH GL 35 - PHARMACOVIGILANCE OF Establishes a standard to construct a
VETERINARY MEDICINAL PRODUCTS: single electronic message to transmit
Electronic Standards for Transfer of Data AERs to all regions
VICH Electronic Transmission Implementation Validation procedures for compliant
Specifications VICH Validation Procedure VMP AERs
Document and Regional Annexes
VICH GL 30 - PHARMACOVIGILANCE OF A listing of the vocabularies for use in
VETERINARY MEDICINAL PRODUCTS: the AER message
Controlled Lists of Terms
VICH Electronic Transmission Implementation Step by step document for
Specifications VICH Step By Step Document implementation of ISO 27953-1 schema
and Regional Annexes compliant message

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1.3 Document Structure

This document is structured to follow GL42 and GL35 and Regional Annexes. Each AER data
element is discussed with a description of the element along with its structure. XPath examples
are included along with sample XML snippets. The sample XML snippets have a defined format
that includes the following:

 Defined AER data element names and element reference values

 codeSystem OIDs that must be used
 Variable sample data (Indicated by the use of italics within the snippet)

1.4 Structure of AER Submission Message

The electronic AER submission structure is based on the ISO 27953-1 schema. Each
submission must follow this model. The complete set of messages is to be bounded by a single
Batch Submission wrapper. Each individual message is bounded by a Transmission and a
Control Act wrapper.

Figure 1-1 Sample AER Submission Format

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Batch Wrapper
Transmission Wrapper Message 1

Control Act Wrapper

Payload

Transmission Wrapper Message 2

Control Act Wrapper

Payload

…...

Transmission Wrapper Message n

Control Act Wrapper

Payload

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The following figure depicts a sample valid XML Batch electronic submission.

Figure 1-2 Sample XML AER Batch Submission

<MCCI_IN200100UV01 xmlns="urn:hl7-org:v3" xmlns:mif="urn:hl7-org:v3/mif"
xmlns:xsi=http://www.w3.org/2001/XMLSchema-instance
xsi:schemaLocation="urn:hl7-org:v3
MCCI_IN200100UV01.xsd" ITSVersion="XML_1.0">
<id root="SubmittingOrganizationID" extension="ABCDrug-20100328-batch-12345"/>
<creationTime value="20120516102030+0300"/>
……..
<versionCode code="VICHAER1.0.0"/>
……..
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
<id root="2.16.840.1.156.3.150" extension="Batch-155-392"/>
<creationTime value="20120515102030+0300"/>

</PORR_IN049006UV>

<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
……
</PORR_IN049006UV>
……
</MCCI_IN200100UV01>

All adverse event electronic transmissions sent must follow this structure to be accepted for
review. Not following this standard and structure will result in the submission being rejected and
not being reviewed.

1.5 Exceptions to Be Noted

Please note that in this document, the XPaths for the data elements are based on an individual
AER message (as depicted in the Figure 1-1, Message 1) without the batch wrapper included in
the XPath. Please add /MCCI_IN200100UV01 in the XPath for the batch wrapper.

For example, the XPath to get “Type of Submission” in an individual AER message without
batch wrapper is:
/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf2/investigationCharacteristic[code/@
code="T95003"]/value/@code

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In a batch message, the XPath to get “Type of Submission” is:

/MCCI_IN200100UV01/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf2/investigati
onCharacteristic[code/@code="T95003"]/value/@code

Also note that, in the HL7 messages of this implementation, the standard date format is
YYYYMMDD. However, for some “date” data elements, for example “Expiration Date”, a partial
date value may be accepted, i.e. date value with only year, or with only year and month, is
acceptable. In these cases, the accepted date format could be YYYYMMDD, YYYYMM, or
YYYY. Please refer to the VICH Validation Procedure Document for specific date data element
for detailed information.

In addition, two “date” data elements, Date of Batch Creation (B.8.1.4) and Date of Message
Creation (B.8.2.4) are required to contain the timestamp information. These two dates are
required to be in the format of YYYYMMDDHHMMSS+/-ZZZZ, where YYYYMMDDHHMMSS
contains the local time including the hour, minute, and second information (HHMMSS), while +/-
ZZZZ is the positive or negative offsets (in hour and minute) of local time from UTC
(Coordinated Universal Time, a time standard and one of the successors to Greenwich Mean
Time (GMT))

The following characters have special meaning in XML, and in general it is suggested to replace
them with their corresponding entity reference when using them.

Entity Reference Character

< < less than
> > greater than
& & ampersand
' ' apostrophe
" " quotation mark

For example, to use code C82440 (<12 hours) in the Vocabulary List for “Length of Time
Between Exposure to VMP and Onset of AE”, reporter needs to replace the “<” character with
“<” as shown in the example below:

<value xsi:type="CE" codeSystem="2.16.840.1.113883.13.50" code="C82440" displayName="<12 hours"/>

1.6 Special Handling of Element Fields (Null Flavors)

The sender should map every data element into the AER message, whether or not it is a
required data element or an optional data element. For data elements that can have repeated
values, e.g., multiple lot numbers and VedDRA terms, the message does not include a repeated
value of nullFlavor “NI” to indicate that there are “no additional values”.

All the data elements should be mapped into the AER message. For optional fields, if the data
are unknown, senders should use the “NI” (No Information) for null flavor, as referenced in the
example below. A sample showing a fully compliant data element is shown and then a fully
compliant data element demonstrating a null flavor is shown.

Fully Compliant XML Snippet

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<observation classCode="OBS" moodCode="EVN">

Fully Compliant Null Flavor XML Snippet

If ”Unknown” or a similar code is in a published vocabulary list for that particular data element
(mandatory or optional) the assigned code and the accompanying term together with the
codeSystem OID should be used, instead of using the null flavor.

All mandatory and optional elements of the AER message must be coded with an actual
value or a null flavor selection specific to the associated data element.
Please note that, null flavor should not be used together with an actual value for the same data
element.
The following table documents the null flavor handling for each element type.

Table 1-2 Null Flavor Element Data Rules

Element Type Null Flavor Rule
Mandatory Coded Element Submitters should use a valid value from the vocabulary list.
Optional Coded Element Should use the null flavor specified for the element when a valid value
is not known. ‘Unknown’ may be included in vocabulary lists.
Mandatory Text Field Submitters should use a valid value. Use of a null flavor is NOT
Element permitted.
Optional Text Field Element Should use null flavors when a valid value is not known. ‘NI – No
Information’ is the default null flavor for this data type.
Mandatory Numeric Field Should contain a valid value. Null flavor use is NOT permitted. Zero
Element may be a valid value (unless otherwise specified by specific business
rules).
Optional Numeric Field Should use a null flavor when a valid value is not known. ‘NI – No
Element Information’ is the default null flavor for this data type.
Mandatory Date Field Should contain a valid date. Null flavor use is NOT permitted.
Element
Optional Date Field Element Should use a null flavor when a valid date is not known. ‘NI – No
Information’ is the default null flavor for this data type.
Optional Text Element Should use a null flavor when a valid value is not known. ‘NI – No
Related to Coded Element Information’ is the default null flavor for this element type.
Boolean Field Elements – Boolean elements have a number of null flavor terms and conditions

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Element Type Null Flavor Rule

Mandatory or Optional for when a null flavor can be used. The allowable null flavors are
“NA”, “NI”, and “UNK”.

1.7 XML Locator Codes

The ISO 27953-1 schema uses a defined set of “observation” classes to capture specific data
elements in the AER message. In order to differentiate each “observation” class, we have
extended this functionality with a list of locator codes to locate the specific data element within
the AER message. The XML Locator Code vocabulary is a listing of these “Observation”
locators.

The following table contains the list of locator codes.

Table 1-3 XML Locator Codes

Code Term
C17998 Outcome Unknown
C21115 Euthanized
C28554 Died
C49495 Recovered With Sequela
C53279 Ongoing
C82467 Recovered / Normal
T95001 MAH
T95002 Sourcereport
T95003 Type Of Submission
T95004 Type Of Information In Report
T95005 Number Of Animals Affected
T95006 Assessment of Health Status Prior to the Exposure to Product
T95007 Are Animals Crossbred
T95008 Breed Components
T95009 RA
T95010 Female Physiological Status
T95011 Weight
T95012 Age
T95013 ATCvet Code
T95015 Use According To Label
T95016 VICH Label Use
T95017 Number Of Defective Items
T95018 Number Of Items Returned
T95019 ORA District Field Office
T95020 Reaction
T95021 Length Of Time Between Exposure To VMP And Onset Of AE
T95022 Serious AE
T95023 Treatment Of AE

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Code Term
T95024 Previous Exposure To The VMP
T95025 Previous AE To The VMP
T95026 Did AE Abate After Stopping the VMP
T95027 Did AE Reappear After Re-Introduction of the VMP
T95028 Species Off-Label
T95029 Route Off-Label
T95030 Overdosed
T95031 Underdosed
T95032 Treatment regimen Off-Label
T95033 Indication Off-Label
T95034 Storage condition Off-Label
T95035 Product expired
T95036 Other off label issue
T95037 Report number(s) of linked report(s)

1.8 Rules Concerning Handling Responses Within Elements

The Adverse Events Processing system will validate and process all AER element responses
using the following data format rules:

 Leading and trailing white space (blanks) will be trimmed for each element value
 White space within an element value will be considered part of the element value
 Case will not be significant nor considered when validating element values

1.9 Vocabulary Reference List of Values

The vocabulary lists to be used for coding AER messages are described in the documents
referenced in Section 1.2 AER Documents. The processing systems use these vocabularies to
validate the information within the AER message.

1.10 MAH to RA Message

The example snippets included in the body of this document for Section 2 Administrative and
Identification Information is for a MAH to RA message. Section 2 also can be used for a RA to
MAH, RA to RA, and a MAH to MAH message (see Section 6 below).

1.11 Disclaimer

For any ISO 27953-1 version AER messages that are submitted for
evaluation and review, please note that the applications and systems will
only capture and process the data elements that are explicitly described in
this document. Any other data elements and/or information that are
included within the submitted messages but are not explicitly described
within this document will be ignored and not processed.

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2 Administrative and Identification Information – GL42

Section A
2.1 Regulatory Authority (RA) – GL42 Section A.1 (A.1.1 – A.1.6)

Information: This is the Regulatory Authority (RA) to which this AER is to be initially submitted
based on which RA has the authority to regulate the product. The sender should enter the “RA
Name”, “RA Street Address”, “RA City”, “RA State/County”, “RA Mail/Zip Code”, and “RA Country”
(3 character code ISO 3166). The codeSystem OID is that for “Locator Codes”, and the XML
Locator Code to be used is “T95009”.

The information required for this section can be found in RA Identifier Code vocabulary list. The
example of US FDA CVM is as follows:

Table 2-1 Regulatory Authority Information

Regulatory
Authority RA RA Zip RA
RA Name RA Address RA City
(RA) State Code Country
Identifier
Food and Drug
7500 Standish
Administration, Maryland
USFDACVM Place (HFV- Rockville 20855 USA
Center for (MD)
199), Room 403
Veterinary Medicine

ICSR Location: RA information is located in the message payload

<primaryInformationRecipient> section of an <investigationEvent> within the <controlActEvent>
element.

XML Details: RA information is captured using <assignedEntity> element as shown in the

sample code below. Note that for “RA Address”, data elements are captured in <addr> element.

Senders should use the <code> element of <assignedEntity> to specify the role played by the
recipient. In this case, set the code value to “T95009”, and set the codeSystem value to the OID
for “Locator Codes” (2.16.840.1.113883.13.206). The code value for a MAH to RA transmission
should be the “RA” value in the code list.

Note that an OID is not required for address information. For “RA Country” data, an ISO 3166 3-
Character Country Code shall be used.

The XPath’s to get the “RA Name” and the “RA Country” code in an AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf1/controlActEvent/primaryInformation
Recipient/assignedEntity[code/@code="T95009"]/representedOrganization/name

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf1/controlActEvent/primaryInformation
Recipient/assignedEntity[code/@code="T95009"]/addr/country

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A sample XML snippet for “RA Name” in an AER message is shown below. Note that this
example uses a US address (the actual address for FDA/CVM). For foreign addresses using
province, simply map the province data into <state> element.

<controlActEvent classCode="CACT" moodCode="EVN">

<primaryInformationRecipient typeCode="PRCP">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.206" code="T95009" displayName="RA"/>
<addr use="WP">
<streetAddressLine>7500 Standish Place (HFV-199), Room 403</streetAddressLine>
<city>Rockville</city>
<state>MD</state>
<postalCode>20855</postalCode>
<country>USA</country>
</addr>
<representedOrganization determinerCode="INSTANCE" classCode="ORG">
<name>Food and Drug Administration Center for Veterinary Medicine</name>
</representedOrganization>
</assignedEntity>
</primaryInformationRecipient>
</controlActEvent>

2.2 Marketing Authorization Holder (MAH) (Sender) – GL42 Section A.2

(A.2.1 - A.2.2.6)

Information: This is the AER “Sender” information. In this example, this is the MAH responsible
for sending the AE information to the RA who is responsible for regulating the VMP.

Sender information consists of three parts: “MAH Information”, “Person Acting on Behalf of MAH”
(optional), and “Sender Category”.

ICSR Location: MAH (Sender) information is located in the AER message payload <author>
section of <investigationEvent> within the <controlActEvent> element, adjacent to the RA (A.1)
node.

XML Details: The MAH part of the “Sender Information” should provide the business name,
street address, city, state/county/province, mail/zip code, and country of the submitting
organization. As with the RA information, the MAH information is captured using
<assignedEntity> element. The “Person Acting on Behalf of MAH” is captured in <contactParty>
child element. The codeSystem OID is for “Locator Codes” and the code value for a MAH to RA
transmission should be the “MAH” value in the code list.

The telecom values for email addresses, phone and fax numbers in AER messages should follow
the following rules to be a valid:

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Table 2-2 Telecom Entry Format Rules

Telecom Entry Rules
Each telecom value must include the type of telecom entry. The
element type choices must be one of the following: “FAX:”, “MAILTO:”,
and “TEL:”. Any other choice will result in the AER being rejected.
If the validation rules allow and all telecom entries are not known then
the complete telecom entry can use a single “NI – No Information”
nullFlavor. It is not required to list each telecom entry with a
nullFlavor. Example:

The XPath’s to locate the “MAH Information”, “Sender Information”, and “Sender Category” in an
AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf1/controlActEvent/author/assignedEntit
y/representedOrganization/name

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf1/controlActEvent/author/assignedEntit
y/representedOrganization/contactParty/contactPerson/name

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf1/controlActEvent/author/assignedEntit
y/representedOrganization/contactParty/telecom[starts-with(@value, "TEL")]/@value

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf1/controlActEvent/author/assignedEntit
y/code/@code

A sample XML snippet for “Sender Category”, “MAH Information” and “Sender Information” in an
AER message is:

<author typeCode="AUT">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.206" code="T95001" displayName="MAH"/>
<addr use="WP">
<streetAddressLine>555 Prosperity Place</streetAddressLine>
<city>Woodbury</city>
<state>TN</state>
<postalCode>12345</postalCode>
<country>USA</country>
</addr>
<representedOrganization determinerCode="INSTANCE" classCode="ORG">
<name> GAP Industries </name>
<contactParty classCode="CON">
<telecom value="TEL:+1-615-5551110-10"/>
<telecom value="FAX:+1-616-5559090"/>
<telecom value="MAILTO:[email protected] "/>
<contactPerson determinerCode="INSTANCE" classCode="PSN">
<name>
<prefix>Dr</prefix>
<given>John</given>
<family>Smith</family>
</name>
</contactPerson>

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</contactParty>
</representedOrganization>
</assignedEntity>
</author>

2.3 Person(s) Involved in AER (Reporter) – GL42 Section A.3 (A.3.1 –

A.3.2.12)

Information: This section contains information on the Reporter(s) who originally reported the AE
(to the sender). A “Primary Reporter” is required. Only one “Other Reporter” can be entered in
the AER message.

ICSR Location: Reporter information is captured in the AER message payload using a couple of
child elements of <investigationEvent>, <outboundRelationship> which wraps the
<relatedInvestigation> node that contains reporter information.

XML Details: Since the <outboundRelationship> element in AER message can be used for other
information related to AER investigation event, when the “Reporter Information” element is
selected, reporters should use the code (“T95002”) for “Sourcereport” to identify that this
<outboundRelationship> element contains “Reporter Information”. To differentiate “Primary
Reporter” from “Other Reporter”, a <priorityNumber> child element is used. For the “Primary
Reporter”, it should be valued as “1”. For the “Other Reporter”, it should be valued as “2”.

Reporters should use <participation> node that contains <assignedEntity> to capture the
“Reporter’s Information”. Use <assignedPerson>’s child element <asIdentifiedEntity> to capture
the “Business Name” information of the reporter if needed (as the value of <name> element under
<assigningOrganization>). If "Business Name" value is not available then use the null flavor “NI”,
as shown in the snippet below.

“Reporter Category” shall be set in <code> element where the code value should be set to one of
the codes listed in Reporter Categories vocabulary list.

The XPath to get the “Primary Reporter’s’ “Last Name” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/outboundRelationship[priorityNumber/@value=1
]/relatedInvestigation[code/@code="T95002"]/participation/assignedEntity/assignedPerson/name/family

The XPath to get the “Reporter Telephone” number of the “Primary Reporter” in the AER
message is:

The following is a sample XML snippet for “Primary Reporter” in an AER message. Note that the
same snippet could be for “Other Reporter” if the second line in the snippet is replaced with
<priorityNumber value="2"/>.

<investigationEvent classCode="INVSTG" moodCode="EVN">

……

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<outboundRelationship typeCode="SPRT">
<priorityNumber value="1"/>
<relatedInvestigation classCode="INVSTG" moodCode="EVN">
<code codeSystem=" 2.16.840.1.113883.13.206" code="T95002" displayName="Sourcereport"/>
<effectiveTime value="20091005"/>
<participation typeCode="AUT">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.194" code="C82470" displayName="Veterinarian"/>
<addr use="WP">
<streetAddressLine>1st Old Street </streetAddressLine>
<city>SmallTown</city>
<state>AZ</state>
<postalCode>12345</postalCode>
<country>USA</country>
</addr>
<telecom value="TEL:+1-888-1234567"/>
<telecom value="FAX:+1-888-1234789"/>
<telecom value="MAILTO:[email protected]"/>
<assignedPerson determinerCode="INSTANCE" classCode="PSN">
<name>
<family>Peterson</family>
<given>Glenn</given>
</name>
<asIdentifiedEntity classCode="IDENT">
<assigningOrganization determinerCode="INSTANCE" classCode="ORG">
<name>Prehistoric Pets Clinic</name>
</assigningOrganization>
</asIdentifiedEntity>
</assignedPerson>
</assignedEntity>
</participation>
</relatedInvestigation>
</outboundRelationship>
</investigationEvent>

2.4 AER Information (Investigation/Report Information) – GL42 Section

A.4 (A.4.1 – A.4.4.3)

Information: This section contains general information about the AER, including:

 A.4.1 Unique Adverse Event Report Identification Number

 A.4.2 Original Receive Date
 A.4.3 Date of Current Submission
 A.4.4 Type of Report
o A.4.4.1 Type of Submission
o A.4.4.2 Reason for Nullification
o A.4.4.3 Type of Information in Report

2.4.1 Unique Adverse Event Report Identification Number – GL42 Section A.4.1

Information: The “Unique Adverse Event Report Identification Number” is Sender’s (Case)
Safety Report Unique Identifier. It contains the 3-Character ISO 3166 Country Code, the 8-

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Character Sender Identifier Code, and a number or number/letter combination that is unique
within the Sender organization.

ICSR Location: This information is located in the AER message payload <id> section of
<investigationEvent> within the <controlActProcess> element. The id root must be hard coded as
“1.2.3.4”. The “extension” attribute captures the Unique Adverse Event Report Identification
Number.

XML Details: The XPath to get the “Unique Adverse Event Report Identification Number” in the
AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/id/@extension

A sample XML snippet for “Unique Adverse Event Report Identification Number” in an AER
message is:

<investigationEvent moodCode="EVN" classCode="INVSTG">

2.4.2 Original Receive Date – GL42 Section A.4.2

Information: This is the date the initial report was received from the primary reporter by the MAH
or RA.

ICSR Location: This information is located in the AER message payload

<outboundRelationship> section of <investigationEvent>, specifically inside the
<relatedInvestigation> child element. Note that this <relatedInvestigation> element is located in
the same <outboundRelationship> element where the “Primary Reporter” element is located.

XML Details: “YYYYMMDD” is the date format to be used for this data element, i.e. the HL7
“Point in Time” (TS) literal form, which is a simple calendar form. To get the day, month, and year
data, the reporter needs to parse the date value.

The XPath to get the “Original Receive Date” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/outboundRelationship[priorityNumber/@value=1
]/relatedInvestigation[code/@code="T95002"]/effectiveTime/@value

A sample XML snippet for “Original Receive Date” in an AER message is:

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2.4.3 Date of Current Submission – GL42 Section A.4.3

Information: This is the date that the current AER was submitted to the RA.

ICSR Location: This information is located in the AER message payload <availabilityTime>
element of <investigationEvent>.

XML Details: The XPath to get the “Date of Current Submission” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/availabilityTime/@value

A sample XML snippet for “Date of Current Submission” in an AER message is:

<investigationEvent classCode="INVSTG" moodCode="EVN">

……..
<availabilityTime value="20110517"/>
……..
</investigationEvent>

2.4.4 Type of Report – GL42 Section A.4.4

Information: This information contains “Type of Submission”, and if this is a nullification report
then this element contains, “Reason for Nullification Report”. It also contains “Type of Information
in Report”.

2.4.4.1Type of Submission
ICSR Location: “Type of Submission” information is located in the AER message payload
<subjectOf2> section of <investigationEvent> within a <investigationCharacteristic> node.

XML Details: The <code> element describes the data element from GL42 (see sample XML
snippet below). In this example, it is the Type of Submission data element. The OID for <code>
codeSystem attribute is the OID of the XML Locator Codes vocabulary
(2.16.840.1.113883.13.206). The <code> code attribute is “T95003” and displayName attribute
value is “Type of Submission”, which come from this vocabulary. The <value> codeSystem
attribute is the OID (2.16.840.1.113883.13.195) of the Type of Submission vocabulary. The
<value> code attribute is “C68624” and displayName attribute “EXPEDITED”, which come from
the Type of Submission vocabulary.

2.4.4.2 Reason for Nullification

ICSR Location: Same as “Type of Submission”.

XML Details: For the element “Reason of Nullification Report”, the information is captured using
a <originalText> element, a child node of <value> element that captures the “Type of Submission”
value. “Reason of Nullification” shall be entered only when the code value for “Type of
Submission” is “C68625”, i.e. “NULLIFICATION”.

The XPath to get “Type of Submission” in the AER message is:

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/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf2/investigationCharacteristic[code/@co
de="T95003"]/value/@code

A sample XML snippet for the “Type of Submission” in an AER message is:

<investigationEvent moodCode="EVN" classCode="INVSTG">

……
<subjectOf2 typeCode="SUBJ">
<investigationCharacteristic classCode="CASE" moodCode="EVN">
<code codeSystem=" 2.16.840.1.113883.13.206" code="T95003" displayName="Type of Submission"/>
<value xsi:type="CE" codeSystem="2.16.840.1.113883.13.195" code="C68624"
displayName="EXPEDITED">
<originalText nullFlavor="NI"/>
</value>
</investigationCharacteristic>
</subjectOf2>
……
</investigationEvent>

The XPath to get to the “Reason for Nullification” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf2/investigationCharacteristic[code/@co
de="T95003"]/value/originalText

A sample XML snippet for “Reason for Nullification” in an AER message is:

<investigationEvent moodCode="EVN" classCode="INVSTG">

……
<subjectOf2 typeCode=”SUBJ”>
<investigationCharacteristic classCode=”CASE” moodCode=”EVN”>
<code codeSystem="2.16.840.1.113883.13.206" code="T95003"
displayName="Type of Submission"/>
<value xsi:type="CE" codeSystem="2.16.840.1.113883.13.195" code="C68625"
displayName="NULLIFICATION">
<originalText>This is the text for the reason</originalText>
</value>
</investigationCharacteristic>
</component4>
……
</investigationEvent>

2.4.4.3Type of Information in Report

ICSR Location: Same as “Type of Submission”.

XML Details: Same as “Type of Submission”, “Type of Information in Report” is captured in a

<investigationCharacteristic> element, but using the XML Locator Code “T95004” to identify the
node. The actual data value is set to one of the codes listed in Type of Information vocabulary.

The XPath to get “Type of Information in Report” in the AER message is:

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/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf2/investigationCharacteristic[code/@co
de="T95004"]/value/@code

A sample XML snippet for “Type of Information in Report” in an AER message is:

<investigationEvent moodCode="EVN" classCode="INVSTG">

……
<subjectOf2 typeCode="SUBJ">
<investigationCharacteristic classCode="CASE" moodCode="EVN">
<code codeSystem="2.16.840.1.113883.13.206" code="T95004"
displayName="Type of Information in Report"/>
<value xsi:type="CE" codeSystem="2.16.840.1.113883.13.196" code="C82452"
displayName="Both Safety And Lack Of Expected Effectiveness"/>
</investigationCharacteristic>
</subjectOf2>
……
</investigationEvent>

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3 Description of AE – GL42 Section B

3.1 Animal Data – GL42 Section B.1 (B.1.1 – B.1.9.3.1)

Information: This information is for the animal data.

ICSR Location: These data elements are provided in the appropriate sections and subsections
of AER message payload, within the <primaryRole> node inside the <subject1> tag of the
<adverseEventAssessment> section.

The Animal Data Elements are described below.

3.1.1 Number of Animals Treated – GL42 Section B.1.1

Information: Number of Animals Treated With VMP

ICSR Location: This data is captured using a <quantity> element inside the <player2> node.
The <player2> node is located inside the <primaryRole> and <subject1> element tags.

XML Details: The XPath to get “Number of Animals Treated” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/player2/quantity/@value

A sample XML snippet for “Number of Animals Treated” in an AER message is:

3.1.2 Number of Animals Affected – GL42 Section B.1.2

Information: This is the number of animals adversely affected by the VMP(s).

ICSR Location: This information is captured as an observation using a <observation> element

inside a <subjectOf2> node.

XML Details: The XPath to get the “Number of Animals Affected” in the AER message is:

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/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95005"]/value/@value

The <code> element describes the data element from GL42 (see sample XML snippet below). In
this example, it is the Number of Animals Affected data element. The OID for <code>
codeSystem attribute is the OID of the XML Locator Codes vocabulary
(2.16.840.1.113883.13.206). The <code> code attribute is “T95005” and displayName attribute
value is “Number of Animals Affected”, which come from this vocabulary. The <value> value
attribute is the number of animals affected, which is “3”.

3.1.2.1 Attending Veterinarian's Assessment of Health Status Prior to VMP – GL42

Section B.1.2.1

Information: This is the attending Veterinarian’s assessment of the health status of the animal(s)
involved in the AE prior to their exposure to the VMP.

ICSR Location: This information is captured as an observation using a <observation> element

inside a <subjectOf2> node.

XML Details: Users should use a proper code to ensure <subjectOf2> contains “Attending
Veterinarian’s Assessment”. The reporter must also use a coded value for the actual assessment
value. The list of codes and values are shown in Vet Health Status Assessment vocabulary list.

The <code> element describes the data element from GL42 (see sample XML snippet below). In
this example, it is the Attending Veterinarian's Assessment of Health Status Prior to VMP data
element. The OID for <code> codeSystem attribute is the OID of the XML Locator Codes
vocabulary (2.16.840.1.113883.13.206). The <code> code attribute is “T95006” and displayName
attribute value is “Assessment of Health Status Prior to the Exposure to Product”, which come
from this vocabulary. The <value> codeSystem attribute is the OID of the Vet Health Status
Assessment vocabulary (2.16.840.1.113883.13.197). The <value> code attribute is “C82488” and
displayName attribute “EXCELLENT”, which come from the Vet Health Status Assessment
vocabulary. The author of the assessment, Veterinarian” is described in the <author> element.
The OID for <code> codeSystem attribute is the OID of the Reporter Categories vocabulary
(2.16.840.1.113883.13.194). The <code> code attribute is “C82470” and displayName attribute
“Veterinarian”, which come from the Reporter Categories vocabulary.
The XPath to get the “Attending Veterinarian's Assessment” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95006" and
author/assignedEntity/code/@code="C82470"]/value/@code

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A sample XML snippet for “Attending Veterinarian's Assessment” in an AER message is:

3.1.3 Species – GL42 Section B.1.3

Information: The species is the species of the animal affected by the VMP.

ICSR Location: Species data is captured in the <primaryRole> in <adverseEventAssessment>

XML Details: This data are provided in code attribute value in the <code> element of <player2>
element. The codeSystem OID is “2.16.840.1.113883.4.341” is for the Species vocabulary list. In
the following sample snippet, the <code> code attribute is “CTT” and displayName attribute value
is “Cattle”, which come from this Species vocabulary.

The XPath to get the “Species” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/player2/code/@code

A sample XML snippet for “Species” in an AER message is:

3.1.4 Breed (Breed Group) – GL42 Section B.1.4

Information: This is the breed(s) of the animal(s) associated with the species chosen in B.1.3.
The VICH codes and values for breed are shown in Breeds vocabulary list. The codeSystem OID
for the Breeds vocabulary list is “2.16.840.1.113883.4.342”.

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ICSR Location: Breed information is captured as an observation(s) using <subjectOf2> node(s).

XML Details: Breed information in an AER message may be purebred and/or crossbred. Up to
two breed <observation> nodes can be used, one for purebred and/or the other for crossbred.
Both cases are modeled similarly.

For purebred, the information is captured as one single observation. The Observation Type Code
(T95007) indicates that this observation is about animal breed. In order to differentiate between
the purebred and crossbreed information, the question is asked “Are Animals Crossbred”. The
observation value is a Boolean value, with “True” indicating crossbred, and “False” that indicates
purebred. The OID for <code> codeSystem attribute is the OID of the XML Locator Codes
vocabulary (2.16.840.1.113883.13.206). The <code> code attribute is “T95007” and displayName
attribute value is “Are Animals Crossbred”, which come from this vocabulary.

The actual breed information for the purebred case is then captured in a single or multiple child
observations using a list of <inboundRelationship> nodes. The <code> element describes the
data element from GL42. In this example, it is the Breed data element. The OID for <code>
codeSystem attribute is the OID of the XML Locator Codes vocabulary
(2.16.840.1.113883.13.206). The <code> code attribute is “T95008” and displayName attribute
value is “Breed Components”, which come from this vocabulary. The <value> codeSystem
attribute is the OID of the Breed vocabulary (2.16.840.1.113883.4.342). The <value> code
attribute is “Pig33” and displayName attribute “Duroc”, which come from the Breed vocabulary.

The XPath to get the purebred information in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95007" and value/@value=false()]/inboundRelationship
/observation/value/@code

A sample XML snippet for capturing the purebred information with multiple purebred animals (2) in
an AER message follows:

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</inboundRelationship>

</observation>
</subjectOf2>

For crossbred, similar to purebred, use the observation type <code> to indicate that this
observation is for breed information, but in this case the Boolean value is set to ‘True’ to indicate
that the observation is for crossbred.

The XPath for crossbred information that will get the list of breeds’ component is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95007" and value/@value=true()]/inboundRelationship
/observation/value/@code

The breed components for the crossbred are captured using a list of nested observations inside
the <sourceOf2> nodes. These observations are handled similar to pure breed observations.

A sample XML snippet for crossbred information including multiple animal breeds (3) in an AER
message is:

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In the following are snippets that illustrate the mapping of breed data in AER message for several
common situations.

Case 1: One animal involved - The reporter knows that the animal is crossbred but does not know
the breeds of the animal. (There are no purebred animals reported.) In the case of a crossbred
animal, the breed that you would report is the generic crossbred code (for example, DOG88).

Case 2: One animal involved - The reporter knows that the animal is purebred but does not know
the breed of the animal. (There are no crossbred animals reported.) In the case of a purebred
animal, when there is no breed reported, one would use the nullFlavor “NI”.

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<observation classCode="OBS" moodCode="EVN">

<code codeSystem="2.16.840.1.113883.13.206" code="T95007" displayName="Are Animals Crossbred"/>
<value xsi:type="BL" nullFlavor="NI"/>
<inboundRelationship typeCode="COMP">
<observation classCode="OBS" moodCode="EVN">
<code codeSystem="2.16.840.1.113883.13.206" code="T95008" displayName="Breed Components"/>
<value xsi:type="CE" nullFlavor="NI"/>
</observation>
</inboundRelationship>
</observation>
</subjectOf2>

Case 3: At least 2 animals - The reporter knows that one animal is purebred and one is crossbred
but does not know the breed of the animals.

Case 4: Breed Unknown - The reporter does not know whether the animals are purebred or
crossbred. This snippet can be used for a human case.

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<code codeSystem="2.16.840.1.113883.13.206" code="T95008" displayName="Breed Components"/>

Case 5: One animal - The reporter knows that the animal is crossbred but only knows one of the
breeds of the animal.

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3.1.5 Gender, Reproductive Status, and Female Physiological Status – GL42

Section B.1.5 - B.1.7

Information: It captures the gender, reproductive status, and physiological status data based on
the animal reported.

ICSR Location: These data elements are all captured inside <primaryRole> element. “Gender”
and “Reproductive Status” codes are both located inside child node <player2>. “Female
Physiological Status” is captured using an observation inside child node <subjectOf2>.

XML Details: “Gender” and “Reproductive Status” are both captured inside <player2>. For
gender status, the code value and displayNames are taken from Gender vocabulary list.

For “Reproductive Status”, reporters should use the code value and displayNames that are found
in Reproductive Status vocabulary list.

For “Female Physiological Status”, an observation is used to capture this information. The
allowed code values and displayNames are found in Female Physiological Status vocabulary list.

The XPath to get the “Gender” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/player2/administrativeGenderCode/@code

The XPath to get the “Reproductive Status” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/player2/genderStatusCode/@code

The XPath to get the “Female Physiological Status” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95010"]/value/@code

A sample XML snippet for “Gender”, “Reproductive Status” and “Female Physiological Status” in
an AER message is:

<adverseEventAssessment classCode="INVSTG" moodCode="EVN">

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<code codeSystem="2.16.840.1.113883.13.206" code="T95010"

displayName="Female Physiological Status"/>
<value xsi:type="CE" codeSystem=" 2.16.840.1.113883.13.49 " code="NPL"
displayName="NONPREGNANT LACTATING"/>
</observation>
</subjectOf2>
……
</primaryRole>
</subject1>
<adverseEventAssessment>

3.1.6 Weight & Age – GL42 Section B.1.8 and B.1.9

Information: The reporter should enter the numerical minimum weight in kilograms (kg)
extended to 3 decimals.

ICSR Location: Weight and Age information are captured using two observations inside
<subjectOf2> elements.

XML Details: For both the “Weight” and “Age” data elements, a method code needs to be set.
The value should be one of the codes and code values shown in Precision Categories vocabulary
list. Both “Weight” and “Age” should use data type IVL_PQ, and use low for the Minimum Weight
and Age values and high for the Maximum Weight and Age values.

For “Age” data, units of measurements must be one of the following valid values: s, min, h, d, wk,
mo, or a (year).

For both “Weight” and “Age” data, if there is only one value, use the <low> element.

The XPath’s to get the code and value of” Weight” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95011"]/methodCode/@code

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95011"]/value/low/@value

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject/1pri
maryRole/subjectOf2/observation[code/@code="T95011"]/value/low/@unit

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95011"]/value/high/@value

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95011"]/value/high/@unit

The XPath’s to get the code and value of “Age” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95012"]/methodCode/@code

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/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code=“T95012"]/value/low/@value

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code=“T95012"]/value/low/@unit

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code=“T95012"]/value/high/@value

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code=“T95012"]/value/high/@unit

A sample XML snippet for Weight and Age in an AER message is:

Note that for any of these data elements, if only one value is available, use <low> element of the
IVL_PQ data type to capture the data, and use a null flavor for the <high> element.

In the following is sample snippet for Weight and Age when GL42 data elements B.1.8.1 and/or
B.1.9.1 value is Unknown.

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<code codeSystem="2.16.840.1.113883.13.206" code="T95012" displayName="Age"/>

3.2 VMP(s) Data and Usage – GL42 Section B.2 (B.2.1 – B.2.6.5)

Information: This section contains information about the VMP(s) that are indicated in the
reported AE, and the usage of the VMP(s).

3.2.1 Registered or Brand Name – GL42 Section B.2.1

Information: The reporter should provide the complete “Registered or Brand Name” for their
approved VMP(s) involved in the adverse event.

ICSR Location: “Registered or Brand Name” information is captured as product information

within an observation, inside <substanceAdminstration>, uses a <kindOfProduct> node.

XML Details: “Registered or Brand Name” should be complete and entered as a text field.
Since multiple VMP(s) could be used, in order to provide the needed references, a
<substanceAdminstration> id is used. Note that this id is only expected to be used within the
context of a single AER. The importance of the “Extension” is to link the same product
information throughout the xml message. This extension should be unique for a product
but not necessarily sequential within the message.

The XPath to get the “Registered or Brand Name” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/substanceAdministration[id/@extension="1"]/consumable/instanceOfKind/kindOfProduct/name

A sample XML snippet for Brand Name in an AER message is:

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</substanceAdministration>
</subjectOf2>

3.2.1.1 Product Code – GL42 Section B.2.1.1

Information: This information is the VMP’s Product Code.

ICSR Location: Product Code information is captured in the same product information node as
B.2.1 “Brand Name” within an observation.

XML Details: Product code is entered as the code value text inside the <consumable> element.
For more details, refer to the Regional Annexes.

The XPath to get the “Product Code” in the AER message is:

A sample XML snippet for “Product Code” in an AER message is:

3.2.1.2 Registration Identifier – GL42 Section B.2.1.2

Information: This is the “Registration Identifier” of the VMP.

ICSR Location: The “Registration Identifier” is captured inside <kindOfProduction> node’s child
element <asManufacturedProduct>, using an <approval> class. It is next to the data element
B.2.1.4 Company or MAH.

XML Details: The XPath to get the “Registration Identifier” in the AER message is:

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A sample XML snippet for “Registration Identifier” in an AER message is:

<subjectOf2 typeCode="SBJ">
<substanceAdministration classCode="SBADM" moodCode="EVN">
<id root="1.2.3.4" extension="1"/>
......
<consumable typeCode="CSM">
<instanceOfKind classCode="INST">
......
<kindOfProduct classCode="MMAT" determinerCode="KIND">
......
<asManufacturedProduct classCode="MANU">
<manufacturerOrganization classCode="ORG" determinerCode="INSTANCE">
<name>Safe Animal Health</name>
</manufacturerOrganization>
<subjectOf typeCode="SBJ">
<approval classCode="CNTRCT" moodCode="EVN">
<id extension="USA-USFDACVM-N141321"/>
</approval>
</subjectOf>
</asManufacturedProduct>
......
</kindOfProduct>
......
</instanceOfKind>
</consumable>
......
</substanceAdministration>
</subjectOf2>

3.2.1.3 Anatomical Therapeutic Chemical Vet (ATCvet) Code – GL42 Section B.2.1.3

Information: The MAH should provide the “ATCvet Code” for their VMP(s).

ICSR Location: Sibling node of B.2.1.2 Registration Identifier, but inside a <asSpecializedKind>
element.

XML Details: “ATCvet Code” is captured using the <name> element value inside the
<asSpecializedKind> node. The <code> element should be used to indicate that this name value
is for the ATCvet code.

The XPath to get the “ATCvet Code” in the AER message is:

A sample XML snippet for “ATCvet Code” in an AER message is:

<subjectOf2 typeCode="SBJ">
<substanceAdministration classCode="SBADM" moodCode="EVN">
<id root="1.2.3.4" extension="1"/>
......

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<consumable typeCode="CSM">
<instanceOfKind classCode="INST">
......
<kindOfProduct classCode="MMAT" determinerCode="KIND">
......

3.2.1.4 Company or MAH – GL42 Section B.2.1.4

Information: This is the name of the “Company or MAH” owning the VMP(s) involved in the AE.

ICSR Location: This data is captured in <asManufacturedProduct> node, inside its

<manufacturerOrganization> child element.

XML Details: This information is captured as free text.

The XPath to get “Company” or “MAH” in the AER message is:

A sample XML snippet for “Company” or “MAH” in an AER message is:

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3.2.1.5 MAH Assessment – GL42 Section B.2.1.5

Information: This is the assessment conducted by the MAH for the association between the use
of the VMP and the AE.

ICSR Location: Located in a <causalityAssessment> element inside a

<adverseEventAssessment> node.

XML Details: The XPath to get “MAH Assessment” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/component/
causalityAssessment[author/assignedEntity/code/@code="T95001"]/value/originalText

A sample XML snippet for “MAH Assessment” in an AER message is shown below. Note that
since the causality assessment is for each VMP, a <productUseReference> element is used to
link the assessment to a particular VMP using the internal <id> to indicate the specific VMP. If
multiple VMPs are used, multiple <causalityAssessment> nodes can be used with <author> being
MAH, one for each VMP.

<adverseEventAssessment classCode="INVSTG" moodCode="EVN">

……
<component typeCode="COMP">
<causalityAssessment classCode="INVSTG" moodCode="EVN">
<value xsi:type="CE">
<originalText>4000 chars here</originalText>
</value>
<author typeCode="AUT">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.206" code="T95001" displayName="MAH"/>
</assignedEntity>
</author>
<subject2 typeCode="SUBJ">
<productUseReference classCode="INFO" moodCode="EVN">
<id extension="1"/>
</productUseReference>
</subject2>
</causalityAssessment>
</component>
<component typeCode="COMP">
<causalityAssessment classCode="INVSTG" moodCode="EVN">
<value xsi:type="CE">

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<originalText>4000 chars here</originalText>

</value>
<author typeCode="AUT">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.206" code="T95001" displayName="MAH"/>
</assignedEntity>
</author>

Please refer to Regional Annexes for regional specific needs concerning MAH Assessment.

3.2.1.6 RA Assessment – GL42 Section B.2.1.6 and B.2.1.6.1

Information: This is the assessment conducted by the RA for the association between the use
of the VMP and the AE based on a RA Assessment Categories vocabulary list. The RA can also
provide an optional explanation relating to assessment.

ICSR Location: Same as “MAH Assessment”, but in another <causalityAssessment> element.

XML Details: Same as “MAH Assessment”, except that the <author> assignedEntity has a code
value for “RA”, instead of “MAH”. For the explanation text element use the <text> child element.
The assessment codes and values are taken from the RA Assessment Categories vocabulary list.

Note that, same as “MAH Assessment”, the “RA Assessment” is tied to VMP. In the case of
multiple products used, multiple <causalityAssessment> nodes should be used, one for each
product.

The XPath to get “RA Assessment” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/component/
causalityAssessment[author/assignedEntity/code/@code="T95009"]/value/@code

A sample XML snippet for “RA Assessment” in an AER message is:

<adverseEventAssessment classCode="INVSTG" moodCode="EVN">

……
<component typeCode="COMP">
<causalityAssessment classCode="INVSTG" moodCode="EVN">
<text>The reason for RA's causality assessment can put here. </text>
<value xsi:type="CE" codeSystem="2.16.840.1.113883.13.201" code="C54154"
displayName="Probable"/>
<author typeCode="AUT">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.206" code="T95009" displayName="RA"/>
</assignedEntity>

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</author>

</causalityAssessment>
</component>
……
</adverseEventAssessment>

3.2.1.7 Route of Exposure (Route of Administration) – GL42 Section B.2.1.7

Information: This information is for the route of exposure for the VMP(s). The codes and values
for “Route of Exposure” are shown in Route of Exposure vocabulary list.

ICSR Location: Located in the context of a substance administration instance. For repeated
route of exposure to same VMP, use the recursive <outboundRelationship2> element in
substance administration element to provide further information.

XML Details: Multiple route of exposure information could be provided, using a list of nested
<substanceAdministration> nodes. Note that the <id> element inside <substanceAdministration>
is used. This <id> is used to internally refer to a specific VMP, so that if a data element such as
Route of Exposure or Causality Assessment needs to associate with a specific VMP, the report
can use this id to link to a specific VMP when multiple VMP(s) are involved in the AE being
reported.

The following XPath is to be used in the AER message when a single “Route of Exposure” is
reported for a product.

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/substanceAdministration[id/@extension="1"]/routeCode/@code

When additional usage of the VMP is recorded (e.g., when one or more of the following elements
have been changed for the VMP usage: route of exposure, dosage, interval of administration, and
date of exposures), the first “Route of Exposure” for a product is specified in the XPath above and
the remaining routes of exposure for that product are captured as “outboundRelationship2” using
the XPath below.

A sample XML snippet for “Route of Exposure” in an AER message is:

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......

<outboundRelationship2 typeCode="SEQL" contextConductionInd="true">
<substanceAdministration classCode="SBADM" moodCode="EVN">
<id root="1.2.3.4" extension="1"/>
……
<routeCode codeSystem="2.16.840.1.113883.13.202" code="C38284" displayName="Nasal">
</routeCode>
……
</substanceAdministration>
</outboundRelationship2>
……
</substanceAdministration>
</subjectOf2>

Please refer to Section 3.2.1.9 for a more complete example snippet for complex VMP usages.

3.2.1.7.1 Dose Administration per Unit – GL42 Section B.2.1.7.1 - B.2.1.7.2

Information: This data element collects the actual dose administered. This is not the label
indicated dose.

ICSR Location: This information is captured right next to “Route of Exposure”, in a

<doseCheckQuantity> element.

XML Details: The “Dose Administration per Unit” data element consists of two parts. The
Numerator and Denominator information each consist of a “value” and “unit”. The unit is captured
using coded value. The “unit” code value can be taken from one of three vocabularies. The Units
of Measurement vocabulary list has a codeSystem OID of "2.16.840.1.113883.6.8". The Units of
Presentation vocabulary list has a codeSystem OID of “2.16.840.1.113883.13.203”. The Dose
Denominator Qualifiers vocabulary list has a codeSystem OID of ”2.16.840.1.113883.13.204”.
Depending on which vocabulary list is used to report the “Unit” the matching codeSystem OID
must be also reported.

The XPath to get the value and unit of Numerator in “Dose Administration per Unit” in the AER
message are:

Replace “numerator” with “denominator” to get the XPath for value and unit of Denominator.

The XPath to get the Numerator value for “Repeated Exposure” in the AER message is:

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A sample XML snippet for “Dose Administration per Unit” that references the Units of Presentation
vocabulary list with a codeSystem OID of “2.16.840.1.113883.13.203” in the numerator; and the
Dose Denominator Qualifiers vocabulary list with an OID of “2.16.840.1.113883.13.204” in the
denominator is shown below.

……
</substanceAdministration>
</outboundRelationship2>
……
</substanceAdministration>
</subjectOf2>

3.2.1.7.2 Interval of Administration – GL42 Section B.2.1.7.1.3

Information: This is the frequency of administration of the VMP(s) involved in the AE. For
example, a tablet is given “once per day” from August 1, 2006 to February 10, 2007.

ICSR Location: They are located next to “Route of Exposure” and “Dose per Administration”.

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XML Details: “Interval of Administration” is captured using an <effectiveTime> node. Use the
<low> element for “Date of First Exposure”, and the <high> element for “Date of Last Exposure”.
The <period> element is used for the “Interval of Administration”. Repeated exposures are
handled the same way as “Route of Administration”, using multiple <outboundRelationship2>
nodes.

The XPath’s to locate the “Interval of Administration” value and unit in the AER message are:

The XPath’s to locate the “Date of First Exposure” and the “Date of Last Exposure” in the AER
message are:

For “Interval of Administration”, the units of measurements must be one of the following valid
values: s, min, h, d, wk, mo, or a (year).

A sample XML snippet for “Interval of Administration”, “Date of First Exposure” and “Date of Last
Exposure” in an AER message is:

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<period value="1" unit="d"/>

</comp>
</effectiveTime>
<routeCode codeSystem="2.16.840.1.113883.13.202" code="C38288" displayName="Oral">
</routeCode>
……
</substanceAdministration>
</outboundRelationship2>
……
</substanceAdministration>
</subjectOf2>

3.2.1.8 Dosage Form – GL42 Section B.2.2.2

Information: Dosage Forms of the VMP(s) that is involved in the AER.

ICSR Location: This information is captured in AER message next to “Brand Name”, in element
<formCode> of <kindOfProduct> within <consumable> element.

XML Details: The code value should be one of the codes from the Dosage Forms vocabulary list
(codeSystem OID = “2.16.840.1.113883.13.205”).

The XPath to get the “Dosage Form” in the AER message is:

A sample XML snippet for “Dosage Form” in an AER message is:

<subjectOf2 typeCode="SBJ">
<substanceAdministration classCode="SBADM" moodCode="EVN">
<id root="1.2.3.4" extension="1"/>
......
<consumable typeCode="CSM">
<instanceOfKind classCode="INST">
......
<kindOfProduct classCode="MMAT" determinerCode="KIND">
......
<name xsi:type="TN">DEXABRAND</name>
<formCode codeSystem="2.16.840.1.113883.13.205" code="C42998" displayName="TABLET">
</formCode>
......
</kindOfProduct>
......
</instanceOfKind>
</consumable>
......
</substanceAdministration>
</subjectOf2>

3.2.1.9 VMP Usage Example

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The following section is a complete example that demonstrates VMP usages that involve two
drugs. Each drug has multiple values in “Route of Administration”, “Dosage Levels”, multiple
“Intervals of Administration”, “Date of First Exposure” and “Date of Last Exposure”.

Example: A data mapping of multiple drugs involved in the AER into the HL7 message. The
examples of drug usages are illustrated below:

Drug#1: Spectramast DC (ATCvet Code: QJ51DD90; Dosage Form: Suspension)

Table 3-1 Usage of Sample Drug 1
Route Dosage Interval of Admin Date of Exposures
Intramammary 1 Tube per 1 Quarter 12 Hours 05/30/2006-06/05/2006
Intramammary 1 Tube per 1 Quarter 1 Day 06/06/2006-06/15/2006

Drug#2: Dexamethasone (ATCvet Code: QA01AC02; Dosage Form: Solution)

Table 3-2 Usage of Sample Drug 2
Route Dosage Interval of Admin Date of Exposures
Oral 10 ml per animal 8 Hours 06/01/2006-06/01/2006
Oral 30 ml per animal 1 Day 06/02/2006-06/02/2006
Oral 30 ml per animal 18 Hours 06/03/2006-06/05/2006
Intramuscular 5 ml per animal 1 Day 06/06/2006-06/10/2006

A sample XML snippet for the drug usage examples shown above:

<adverseEventAssessment classCode="INVSTG" moodCode="EVN">

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</denominator>
</doseCheckQuantity>
<consumable typeCode="CSM">
<instanceOfKind classCode="INST">
......
<kindOfProduct classCode="MMAT" determinerCode="KIND">
<code codeSystem="2.16.840.1.113883.6.69" code="01234-*444"/>
<name xsi:type="TN">Spectramast DC</name>
<formCode codeSystem="2.16.840.1.113883.13.205" code="C42994"
displayName="SUSPENSION">

</formCode>

<asManufacturedProduct classCode="MANU">
<manufacturerOrganization classCode="ORG" determinerCode="INSTANCE">
<name>Safe Animal Health</name>
</manufacturerOrganization>
<subjectOf typeCode="SBJ">
<approval classCode="CNTRCT" moodCode="EVN">
<id extension="USA-USFDACVM-N141321"/>
……
</approval>
</subjectOf>
</asManufacturedProduct>

<outboundRelationship2 typeCode="SEQL" contextConductionInd="true">

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</numerator>
<denominator xsi:type="PQ" value="1">
<translation codeSystem="2.16.840.1.113883.13.204" code="C94851"
displayName="Quarter"/>
</denominator>
</doseCheckQuantity>

</substanceAdministration>
</outboundRelationship2>
......
</substanceAdministration>
</subjectOf2>

<subjectOf2 typeCode="SBJ">
<substanceAdministration classCode="SBADM" moodCode="EVN">
<id root="1.2.3.4" extension="2"/>
<effectiveTime xsi:type="SXPR_TS">
<comp xsi:type="IVL_TS">
<low value="20060601"/>
<high value="20060601"/>
</comp>
<comp xsi:type="PIVL_TS">
<period value="8" unit="h"/>
</comp>
</effectiveTime>
<routeCode codeSystem="2.16.840.1.113883.13.202" code="C38288" displayName="Oral">
</routeCode>
<doseCheckQuantity>
<numerator xsi:type="PQ" value="10">
<translation codeSystem="'2.16.840.1.113883.6.8" code="mL" displayName="mL"/>
</numerator>
<denominator xsi:type="PQ" value="1">
<translation codeSystem="2.16.840.1.113883.13.204" code="C14182" displayName="Animal"/>
</denominator>
</doseCheckQuantity>
<consumable typeCode="CSM">
<instanceOfKind classCode="INST">
......
<kindOfProduct classCode="MMAT" determinerCode="KIND">
<code codeSystem="2.16.840.1.113883.6.69" code="01234-*555"/>
<name xsi:type="TN">Dexamethaasone</name>
<formCode codeSystem="2.16.840.1.113883.13.205" code="C42986"
displayName="SOLUTION">
</formCode>

<asManufacturedProduct classCode="MANU">
<manufacturerOrganization classCode="ORG" determinerCode="INSTANCE">
<name>Another Safe Animal Health Inc</name>
</manufacturerOrganization>
<subjectOf typeCode="SBJ">
<approval classCode="CNTRCT" moodCode="EVN">
<id extension="USA-USFDACVM-N141321"/>
……
</approval>
</subjectOf>

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</asManufacturedProduct>

<outboundRelationship2 typeCode="SEQL" contextConductionInd="true">

<outboundRelationship2 typeCode="SEQL" contextConductionInd="true">

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<outboundRelationship2 typeCode="SEQL" contextConductionInd="true">

</substanceAdministration>
</outboundRelationship2>
......
</substanceAdministration>
</subjectOf2>

......
</primaryRole>
</subject1>
</adverseEventAssessment>

3.2.2 Active Ingredient(s) – GL42 Section B.2.2

Information: This section captures the active ingredients, the strength of the active ingredient,
and the dosage form of the reported VMP.

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3.2.2.1 Active Ingredient(s) – GL42 Section B.2.2.1

Information: Mandatory for MAH product(s). For all non-MAH products, this is optional if B.2.1
Registered or Brand Name is provided.

ICSR Location: This information is captured in AER message next to “Brand Name”, in element
<ingredient> inside <kindOfProduct> within a <consumable> node.

XML Details: If more than one active ingredient needs to be included, use a list of <ingredient>
elements. Ingredient strength is reported as a ratio of the two quantities. Both the numerator and
denominator information needs to be included. Use the Units of Measurement vocabulary list for
numerator code and term values and either the Units of Measurement or the Units of Presentation
vocabulary lists for denominator code and term values. For more details concerning the Active
Ingredient Code, refer to the Regional Annexes.

The XPath to get the “Active Ingredients Name” is:

The XPath to get the “Strength” (value and unit), the numerator part in the AER message is:

Substitute “numerator” with “denominator” in the above XPath’s for the denominator part of the
“Strength” data.

The XPath to get the “Active Ingredients” code in the AER message is:

A sample XML snippet for “Active Ingredients” in an AER message is:

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<numerator xsi:type="PQ" value="5">

<translation codeSystem="2.16.840.1.113883.6.8" code="mL" displayName="mL"/>
</numerator>
<denominator xsi:type="PQ" value="1">
<translation codeSystem="2.16.840.1.113883.6.8" code="L" displayName="L"/>
</denominator>
</quantity>
<ingredientSubstance determinerCode="KIND" classCode="MMAT">
<code codeSystem="2.16.840.1.113883.4.9" code="7S5I7G3JQL"/>
<name xsi:type="TN">DEXAMETHASONE</name>
</ingredientSubstance>
</ingredient>
......
</kindOfProduct>
......
</instanceOfKind>
</consumable>
......
</substanceAdministration>
</subjectOf2>

Please note, if the strength unit is unknown, reporter shall use the actual code for unknown
(C17998) which is provided in the vocabulary list mentioned above. A sample snippet for
unknown strength unit is provided below.

<ingredient classCode="INGR">

<quantity>
<numerator xsi:type="PQ" value="1">
<translation codeSystem="2.16.840.1.113883.6.8" code="C17998" displayName="Unknown"/>
</numerator>
<denominator xsi:type="PQ" value="1">
<translation codeSystem="2.16.840.1.113883.6.8" code="C17998" displayName="Unknown"/>
</denominator>
</quantity>
<ingredientSubstance determinerCode="KIND" classCode="MMAT">
<code codeSystem="2.16.840.1.113883.4.9" code="7S111G1XYZ"/>
<name xsi:type="TN">The-Ingredient-Name</name>
</ingredientSubstance>
</ingredient>

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3.2.3 Lot Number and Expiration Date – GL42 Section B.2.3, B.2.3.1

Information: This section includes information about the Lot Number and Expiration Date of the
reported VMP.

ICSR Location: Inside a particular product instance of a product.

XML Details: These data elements are captured inside the <instanceOfKind> element of the
<consumable> element that represents the drug product. “Expiration Date” is captured in
<expirationTime>. “Lot Number” is captured within the text element <lotNumberText>.

The XPath to get the “Lot Number” in the AER message is:

The XPath to get the “Expiration Date” in the AER message is:

A sample XML snippet for “Lot Number” and “Expiration Date” in an AER message is:

Note that for “Expiration Date” a partial date value, i.e. date value with only year, or with only year
and month, is acceptable. Please refer to VICH Validation Procedure Document for more details.

For multiple lots of one drug product, use multiple <member> elements of
<productInstanceInstance> element, one for each lot. Following is an example of two lots for one
drug product.

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</productInstanceInstance>
......
</instanceOfKind>
</consumable>
......
</substanceAdministration>
</subjectOf2>

3.2.4 Who Administered the VMP (Administered or Performed by) – GL42 Section
B.2.4

Information: The category of the person who administered the VMP involved in the AE.

ICSR Location: Captured using a <performer> element, inside a substance administration

class.

XML Details: Use the Administrators of VMP vocabulary list for the code attribute.

The XPath to get the “Who Administered the VMP” in the AER message is:

A sample XML snippet for “Who Administered the VMP” in an AER message is:

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......
<performer typeCode="PRF">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.208" code="C82468" displayName="ANIMAL OWNER"/>
</assignedEntity>
</performer>
......
</substanceAdministration>
</subjectOf2>

3.2.5 Use According to Label – GL42 Section B.2.5

Information: Information on whether the VMP was used according to its label
recommendations. If off-label use was employed then provide an explanation.

ICSR Location: Next to the data element for “Who Administered the VMP”, but captured using
an observation class inside of <outboundRelationship2> elements where the reporter can provide
additional related information.

XML Details: Two <outboundRelationship2> nodes should be used for label use information.
One node is used to capture if the VMP was used according to the label. The other node is used
to capture the explanation if the VMP was indeed used off-label. For the
<outboundRelationship2> node that is used for capturing the off-label use explanation, a list of
nine nested <outboundRelationship2> nodes is used to capture the off-label use explanation.
One is used for each Off-Label use reason.

If “False (no)” is chosen for “Use According to Label”, the reporter must provide an explanation by
selecting the appropriate VICH label use code. If “True (yes)” is chosen for “Use According to
Label”, the reporter still needs to use the nine nested <outboundRelationship2> nodes for the off
label use explanation, however all the values should be set to use nullflavor “NI”.

The XPath to get “Use According to Label” in the AER message is:

The XPath to get “Explanation for Label Use” in the AER message is:

A sample XML snippet for ”Use According to Label” and “Explanation for Off-Label Use” in an
AER message is provided below. Please note that, for the nine “Explanation for Off-Label Use”
elements, the data type is Boolean (BL) type. However, the only acceptable Boolean value is
"True". The only acceptable null flavor is "NI".

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......
<outboundRelationship2 typeCode="PERT" contextConductionInd="true">
<observation classCode="OBS" moodCode="EVN">
<code codeSystem="2.16.840.1.113883.13.206" code="T95015"
displayName="Use According to Label"/>
<value xsi:type="BL" value="false"/>
</observation>
</outboundRelationship2>
<outboundRelationship2 typeCode="PERT" contextConductionInd="true">
<observation classCode="OBS" moodCode="EVN">
<code codeSystem="2.16.840.1.113883.13.206" code="T95016"
displayName="VICH Label Use"/>

<outboundRelationship2 typeCode="PERT" contextConductionInd="true">

<observation moodCode="EVN" classCode="OBS">
<code codeSystem="2.16.840.1.113883.13.206" code="T95028"
displayName="Species Off-Label"/>
<value xsi:type="BL" value="true"/>
</observation>
</outboundRelationship2>
<outboundRelationship2 typeCode="PERT" contextConductionInd="true">
<observation moodCode="EVN" classCode="OBS">
<code codeSystem="2.16.840.1.113883.13.206" code="T95029"
displayName="Route Off-Label"/>
<value xsi:type="BL" nullFlavor="NI"/>
</observation>
</outboundRelationship2>
<outboundRelationship2 typeCode="PERT" contextConductionInd="true">
<observation moodCode="EVN" classCode="OBS">
<code codeSystem="2.16.840.1.113883.13.206" code="T95030" displayName="Overdosed"/>
<value xsi:type="BL" value="true"/>
</observation>
</outboundRelationship2>
<outboundRelationship2 typeCode="PERT" contextConductionInd="true">
<observation moodCode="EVN" classCode="OBS">
<code codeSystem="2.16.840.1.113883.13.206" code="T95031" displayName="Underdosed"/>
<value xsi:type="BL" nullFlavor="NI"/>
</observation>
</outboundRelationship2>
<outboundRelationship2 typeCode="PERT" contextConductionInd="true">
<observation moodCode="EVN" classCode="OBS">
<code codeSystem="2.16.840.1.113883.13.206" code="T95032"
displayName="Treatment regimen Off-Label"/>
<value xsi:type="BL" nullFlavor="NI"/>
</observation>
</outboundRelationship2>
<outboundRelationship2 typeCode="PERT" contextConductionInd="true">
<observation moodCode="EVN" classCode="OBS">
<code codeSystem="2.16.840.1.113883.13.206" code="T95033"
displayName="Indication Off-Label"/>
<value xsi:type="BL" nullFlavor="NI"/>
</observation>
</outboundRelationship2>
<outboundRelationship2 typeCode="PERT" contextConductionInd="true">
<observation moodCode="EVN" classCode="OBS">
<code codeSystem="2.16.840.1.113883.13.206" code="T95034"

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displayName="Storage condition Off-Label"/>

</observation>
</outboundRelationship2>
......
</substanceAdministration>
</subjectOf2>

3.3 Adverse Event Data – GL42 Section B.3 (B.3.1 – B.3.10)

This section contains information about the adverse event being reported.

3.3.1 Narrative of AE – GL42 Section B.3.1

Information: This data element captures the narrative description of the sequence of the
adverse event.

ICSR Location: It is captured inside the <text> element of the investigative event.

XML Details: Required.

The XPath to get “Narrative of AE” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/text

A sample XML snippet for “Narrative of AE” in an AER message is:

<investigationEvent moodCode="EVN" classCode="INVSTG">

……
<text mediaType="text/plain">
The sows and gilts were given the two medications. Two days after receiving the
chloratetracycline penicillin combination in the feed the sows and gilts started going
off feed. A closer inspection of GAP7777 FOR USA-124578 indicated some kind
of foreign contaminant in the Type A medicated article bag.
SUPPLEMENTAL:document number one was supplied by attending vet.
Document number two was supplied by ABC Labs, Inc. at the request of the attending vet.

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</text>
……
</investigationEvent>

3.3.2 Adverse Clinical Manifestations (AER Term Name) – GL42 Section B.3.2

Information: Adverse clinical manifestations observed in the AE.

ICSR Location: It is captured in the reaction that triggers the investigation event.

XML Details: The VeDDRA medical terminology code shall be used for this data element. The
“code” and the associated “displayName” will be the lowest level key value (LLT Key) entry. The
reporter is also required to indicate the version of the VeDDRA table used by storing the version
number in the “codeSystemVersion” element attribute.

The <code> element describes the data element from GL42 (see sample XML snippet below). In
this example, it is the adverse clinical manifestations data element. The OID for <code>
codeSystem attribute is the OID of the XML Locator Codes vocabulary
(2.16.840.1.113883.13.206). The code attribute value is “T95020” and displayName attribute
value is “Reaction”, which come from this vocabulary. The <value> codeSystem attribute is the
OID of the VeDDRA Terms vocabulary (2.16.840.1.113883.4.358). The <value> code attribute is
“984” and displayName attribute “Death”, which come from the VeDDRA Terms vocabulary. The
codeSystemVersion is the version of the VeDDRA Terms vocabulary associated with this code
(7).

The <observationRange> node is used to captured the number of animals (10) associated with
the adverse clinical manifestation. The OID for <interpretationCode> codeSystem attribute is the
OID for the Accuracy of No. of Animals vocabulary list (2.16.840.1.113883.13.209). The code
attribute is “C25498” and displayName attribute value is “Estimated”, which come from this
vocabulary.

The XPath to get “Adverse Clinical Manifestations” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95020"]/value/@code

The number of animals affected is mapped using a reference observation inside clinical
manifestation observation. The XPath to get “Number of Animals Affected per Adverse Clinical
Manifestations” in the AER message is:

The XPath to get the “Accuracy of the Number of Animals” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95020"]/referenceRange/observationRange/interpretationCode/@co
de

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If multiple clinical signs need to be reported in the AER message, repeat the <subjectOf2> node
that contains the observation, one for each clinical sign.

A sample XML snippet for “Adverse Clinical Manifestations” in an AER message is:

<adverseEventAssessment classCode="INVSTG" moodCode="EVN">

3.3.3 Date of Onset of AE (AE Start Date) – GL42 Section B.3.3

Information: This is the date of the first clinical manifestation of the AE.

ICSR Location: The element is located in the adverse event assessment class, mapped as an
observation.

XML Details: The information is captured using a <effectiveTime> element. The <low> value is
the date of onset of the AE, and the <width> is the duration of AE. For the “AE Duration Time
Units” element, the <unit> of measurement must be one of the following valid values: s, min, h, d,
wk, mo, or a (year).

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The XPath to get “Date of Onset of AE” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95020"]/effectiveTime/low/@value

A sample XML snippet for “Date of Onset of AE” in an AER message is:

<adverseEventAssessment classCode="INVSTG" moodCode="EVN">

</observation>
</subjectOf2>

......
</primaryRole>
</subject1>
</adverseEventAssessment>

3.3.4 Length of Time between Exposure to VMP and Onset of AE – GL42 Section
B.3.4

Information: Length of time refers to the time difference between the exposure to VMP and
onset of AE.

ICSR Location: This data element is captured in an observation of the investigative subject,
inside a <subjectOf2> element.

XML Details: A code value should be used for “Length of Time between Exposure to VMP and
Onset of AE”. The code should correspond to one of the length of time contained in Exposure
and Onset Time vocabulary list.

The XPath to get “Length of Time Between Exposure to VMP and Onset of AE” in the AER
message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95021"]/value/@code

A sample XML snippet for” Length of Time Between Exposure to VMP and Onset of AE” in an
AER message is:

<subjectOf2 typeCode="SBJ">
<observation classCode="OBS" moodCode="EVN">
<code codeSystem="2.16.840.1.113883.13.206" code="T95021"

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displayName="Length of Time Between Exposure to VMP and Onset of AE"/>

3.3.5 Duration of AE – GL42 Section B.3.5, B.3.5.1, B.3.5.1.1

Information: This is the duration of the AE, in the actual or approximate length of time the AE
lasted.

ICSR Location: The element is located in the adverse event assessment class, mapped as an
observation.

The XPath to get the “AE Duration – value” in an AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95020"]/effectiveTime/width/@value

The XPath to get the “AE Duration Time Units” in an AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95020"]/effectiveTime/width/@unit

A sample XML snippet for “Duration of AE” in an AER message is:

<adverseEventAssessment classCode="INVSTG" moodCode="EVN">

</observation>
</subjectOf2>

......
</primaryRole>
</subject1>
</adverseEventAssessment>

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3.3.6 Serious AER (Serious AE as Reported) – GL42 Section B.3.6

Information: This data element indicates whether the AER is being reported as a serious AE.

ICSR Location: This data element is captured as an observation, inside an

<investigationCharacteristic> > class, as a reference of the investigation event.

XML Details: HL7 Boolean values will be used.

The XPath to get “Seriousness of AE” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf2/investigationCharacteristic[code/@co
de="T95022"]/value/@value

A sample XML snippet for “Seriousness of AE” in an AER message is:

3.3.7 Treatment of AE – GL42 Section B.3.7

Information: This data element indicates whether the human or animal involved in the AE was
treated for the AE.

ICSR Location: This data element is located inside a <subjectOf2> observation of the adverse
event assessment subject class.

XML Details: “Treatment of AE” is captured as an observation, using <code> node for
observation type, and using the <value> node for the actual observation value. HL7 Boolean
values and the HL7 null flavor will be used.

The XPath to get “Treatment of AE” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="T95023"]/value/@value

A sample XML snippet for “Treatment of AE” in an AER message is:

3.3.8 Outcomes to Date – GL42 Section B.3.8 (B.3.8.1 – B.3.8.6)

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Information: This provides a number of possible outcome categories for the animal(s) affected
in the adverse event. These categories are: Ongoing, Recovered/Normal, Recovered with
Sequela, Died, Euthanized, Unknown (Outcome Unknown).

ICSR Location: These data elements are captured using a list of observations of investigative
subject.

XML Details: Six observation nodes are used. One is used for each outcome category to
capture this information.

The XPath to get “Ongoing” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/pri
maryRole/subjectOf2/observation[code/@code="C53279"]/value/@value

Use the same XPath for other “Outcomes to Date” data elements (“Recovered/Normal”,
“Recovered with Sequela”, “Died”, “Euthanized” and “Outcome Unknown”) by simply replacing the
observation code value in XPath predicate.

A sample XML snippet for “Outcomes to Date” data elements (“Recovered/Normal”, “Recovered
with Sequela”, “Died”, “Euthanized” and “Outcome Unknown”) in an AER message is:

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3.3.9 Previous Exposure to the VMP – GL42 Section B.3.9

Information: This relates to previous exposures to the VMP that occurred before the reported
“Date of First Exposure” given in this report.

ICSR Location: Located in an observation of investigative subject, inside the substance

administration process node.

XML Details: Using <code> to identify that the observation is for this data element, use <value>
to provide the actual data. HL7 Boolean values and the HL7 null flavor will be used.

The XPath to get “Previous Exposure to VMP” in the AER message is:

A sample XML snippet for “Previous Exposure to VMP” in an AER message is:

3.3.10 Previous AE to VMP – GL42 Section B.3.10

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Information: This field refers only to clinical manifestations that occurred during the previous
exposure mentioned in B.3.9 above.

ICSR Location: Same as B.3.9, except that this data element is in another observation element.

XML Details: Same as B.3.9, except that in the observation type <code> node, the code
attribute value should be the code that indentifies this data element. HL7 Boolean values and the
HL7 null flavor will be used.

The XPath to get “Previous AE to VMP” in the AER message is:

A sample XML snippet for “Previous AE to VMP” in an AER message is:

3.4 Dechallenge - Rechallenge Information – GL42 Section B.4 (B.4.1 –

B.4.2)

Information: The information in this section relates to affected animal(s). This set of fields will
be used for cases where dechallenge or rechallenge occur.

3.4.1 Did AE Abate After Stopping the VMP – GL42 Section B.4.1

3.4.2 Did AE Reappear After Re-introduction of the VMP – GL42 Section B.4.2

ICSR Location: Same as B.3.10, data elements in B.4.1 and B.4.2 are captured in observations.
There is one observation for each data element. The code value in <code> that identifies the
observation type is different for 3.4.1 and 3.4.2. HL7 Boolean values and the HL7 null flavor will
be used.

XML Details: Same as B.3.10. Note the difference in code value in the predicates.

The XPath to get “Did AE Abate After Stopping the VMP” in the AER message is:

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The XPath to get “Did AE Reappear After Re-introduction of the VMP” in the AER message is:

A sample XML snippet for “Did AE Abate After Stopping the VMP” and ”Did AE Reappear After
Re-introduction of the VMP“ in an AER message is:

<outboundRelationship2 typeCode="PERT" contextConductionInd="true">

3.5 Assessment of AE – GL42 Section B.5

Information: This is the assessment of the attending veterinarian regarding the association
between the VMP and the AE.

ICSR Location: Located in a causality assessment class instance that is associated with the
adverse event assessment that triggers the investigation event.

XML Details: This data element must use the coded value. A list of values is shown in
Attending Veterinarian’s Causality Assessment vocabulary list.

The XPath to get the “Assessment of AE” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/component/
causalityAssessment[author/assignedEntity/code/@code="C82470"]/value/@code

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A sample XML snippet for “Assessment of AE” in an AER message is:

3.6 Report Number(s) of Linked Report(s) – Section GL42 B.6 (B.6.1 –

B.6.1.1)

Information: This section lists the “Report Number(s) of Linked Report(s)” information on a
specific AER to be submitted to the RA.

ICSR Location: Located inside the investigationCharacteristic that is close to data element such
as A.4.4.1 Type of Submission.

XML Details: This data element is captured in an <investigationCharacteristic> node, an XML

Locator Code (T95037) is used to identify that this is the node for “Linked Report Number”. The
value of linked report number is captured as a text value. The explanation for the link type is
captured as a coded value from the Explanation for Linkage vocabulary list. If more than one
linked report number needs to be reported, a list of such <investigationCharacteristic> nodes can
be used, one for each linked report.

The XPath to get the “Report Number of Linked Report” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf2/investigationCharacteristic[code/@co
de="T95037"]/value/originalText

The XPath to get the Type of Link for a linked report in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/subjectOf2/investigationCharacteristic[code/@co
de="T95037"]/value/@code

A sample XML snippet for “Number(s) of Linked Report(s)” in an AER message is:

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<subjectOf2 typeCode="SUBJ">
<investigationCharacteristic moodCode="EVN" classCode="CASE">
<code codeSystem="2.16.840.1.113883.13.206" code="T95037"
displayName="Report number(s) of linked report(s)"/>
<value xsi:type="CD" codeSystem="2.16.840.1.113883.13.219" code="LTPO"
displayName="Parent – Offspring">
<originalText>USA-FDASENDR-2010-US-04321</originalText>
</value>
</investigationCharacteristic>
</subjectOf2>
<subjectOf2 typeCode="SUBJ">
<investigationCharacteristic moodCode="EVN" classCode="CASE">
<code codeSystem="2.16.840.1.113883.13.206" code="T95037"
displayName="Report number(s) of linked report(s)"/>
<value xsi:type="CD" codeSystem="2.16.840.1.113883.13.219" code="LTSP"
displayName="Same Patient">
<originalText>USA-FDASENDR-2009-US-05678</originalText>
</value>
</investigationCharacteristic>
</subjectOf2>

3.7 Supplemental Documents – Section GL42 B.7

Information: This section lists the “Supplemental Documents” information on a specific AER to
be submitted to the RA. Please note that “Supplemental Documents” should be embedded in the
AER message file, and binary “Supplemental Documents” should be embedded as Base-64
encoded data.
Each “Supplemental Document” is mapped into the <document> node inside the <reference>
element that is associated with the investigation event. In the case that multiple supplemental
documents need to be attached, reporters can use multiple <reference> nodes in the AER
message, one for each “Supplemental Document”. Reporters should use a unique <id> element
to specify each document.

3.7.1 Attached Document Filename – GL42 Section B.7.1

Information: This is the proper name of the “Supplemental Document”. The filename must
contain the 3-character file extension of the acceptable file kind.

ICSR Location: This element is located within the <title> element within the <document> node.

XML Details: The XPath to get to the “Supplemental Document Filename” in the AER message
is:
/PORR_IN049006UV/controlActProcess/subject/investigationEvent/reference/document/title

3.7.2 Attached Document Type – GL42 Section B.7.1.1

Information: VICH has defined the types of “Supplemental Document(s)” that it will accept. The
list of acceptable document type is in the Attached Document Type vocabulary list.

ICSR Location: This element is located within the <code> element of the <document> node.
The Attached Document Type vocabulary list should be used for this data element.

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XML Details: The XPath to get the “Supplemental Document Type” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/reference/document/code/@code

3.7.3 Supplemental Document Data

Information: The “Supplemental Document” itself should be embedded inside the <text>
element of the <document> node. Binary “Supplemental Documents”, for example a graphic GIF
file, should be Base-64 encoded.

ICSR Location: This element is located within the <text> element of the <document> node;
"B64" should be used as the attribute value.

XML Details: The XPath to get to the “Supplemental Document Data” in the AER message is:

/PORR_IN049006UV/controlActProcess/subject/investigationEvent/reference/document/text

A sample XML snippet for a “Supplemental Document”, including an “Attached Document

Filename”, “Attached Document Type”, and a “Supplemental Document Data” is shown in the
following XML snippet.

<investigationEvent classCode="INVSTG" moodCode="EVN">

......
<reference typeCode="REFR">
<document classCode="DOC" moodCode="EVN">
<id extension="1"/>
<code codeSystem="2.16.840.1.113883.13.211" code="C68623"
displayName="Necropsy (Autopsy)"/>
<title>necpicture.jpg</title>
<text mediaType="text/plain" representation="B64">
R0lGODlhZABqALMAAFrMYr/BvlKOVJKOg2xZUKmenMfDw8tgWJpVUbaxsPb19v///+bm5tfX1wAAAAAAAC
wAAAAAZABqAAAE/3DJSau9mCrGWhkFIopF2TSMkq1s674rk4x0TRB1ETQq7P/AS6gmOhiPRxuu0Ag6nyzGC
EmtVmkFqHa7MByK1rCV8OWagwUjTsw2FhG9s5ylQCRxtIF+gNjTvmtfDHOEGQ12
…… more Base-64 data …...
</text>
</document>
</reference>

<reference typeCode="REFR">
<document classCode="DOC" moodCode="EVN">
<id extension="2"/>
<code codeSystem="2.16.840.1.113883.13.211" code="C36292"
displayName="Laboratory Report"/>
<title>labreport.pdf</title>
<text mediaType="text/plain" representation="B64">
JVBERi0xLjQNJeLjz9MNCjYgMCBvYmo8PC9IWzQ3NiAxMzNdL0xpbmVhcml6ZWQgMS9FIDE3OTAvTCA1N
jg5L04gMS9PIDkvVCA1NTIzPj4NZW5kb2JqDSAgICAgICAgICAgICAgICAgICAgICAgICAgDQp4cmVmDQo2I
DkNCjAwMDAwMDAwMTYgMDAwMDAgbg0KMDAwMDAwMDYwOSAwMDA
...... more Base-64 data ......
</text>
</document>
</reference>
......

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</investigationEvent>

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4 AER Wrapper Information

This group of data elements contains information that is captured in one of the ISO 27953-1
schema wrappers.

4.1 Batch Wrapper (Section B.8.1 – B.8.1.6)

This section contains data elements that will be captured within the batch wrapper of the report.

4.1.1 Batch Number/Identifier (B.8.1.1.1 – B.8.1.1.2)

Information: The “Batch Number/Identifier” information identifies the collection of reports in this
batch as a complete submission message. The concatenation of Batch Number/Identifier Root
and Extension uniquely identifies each batch of reports. It is the sender’s responsibility to define
and assign this identifier, as each batch submission should have a unique identifier. A “Batch
Number/Identifier” should be supplied even if only one AER is within the batch.

ICSR Location: This information is located in the Batch Wrapper. It is captured in the <id>
element.

XML Details: The “Batch Identifier” of this batch transmission of AER reports is captured in the
extension attribute of <id> element. The <id> root attribute (Batch Number/Identifier - Root)
should be populated with the submitting organization’s unique “sender identifier”. The <id>
extension attribute (Batch Number/Identifier - Extension) is a unique tracking number within the
sender system assigned to a specific batch file transmitted by the sender. The form and format of
this element is up to the creator of the batch.

The XPath to get “Batch ID” in the AER message is:

/MCCI_IN200100UV01/id/@extension

A sample XML snippet for “Batch ID” in the AER message is:

<MCCI_IN200100UV01>
<id root="SubmittingOrganizationID" extension="ABCDrug-20100328-batch-12345"/>
</MCCI_IN200100UV01>

4.1.2 Batch Sender (B.8.1.2.1 – B.8.1.2.8)

Information: This information identifies the sender who is responsible for any technical
communications between receiver and sender regarding the batch transmission of the AER
message.

ICSR Location: This information is located in the Batch Wrapper. It is captured in the batch
sender class.

XML Details: The sender could provide an ID and contact information inside <sender> node.

The XPath to get “Batch Sender” in the AER report is:

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/MCCI_IN200100UV01/sender

A sample XML snippet for “Batch ID” in the AER message is:

<MCCI_IN200100UV01>
<sender>
<device determinerCode="INSTANCE" classCode="DEV">
<id/>
<asAgent classCode="AGNT">
<representedOrganization determinerCode="INSTANCE" classCode="ORG">
<id root="batch-sender-identifier-id" extension="sender organization name"/>
<notificationParty classCode="CON">
<id/>
<telecom value="TEL:+1-123-4567890"/>
<telecom value="FAX:+1-123-456789"/>
<telecom value="MAILTO:[email protected]"/>
<contactPerson>
<id/>
<name>
<prefix>Ms</prefix>
<given>Jane</given>
<family>Doe</family>
</name>
</contactPerson>
</notificationParty>
</representedOrganization>
</asAgent>
</device>
</sender>
</MCCI_IN200100UV01>

4.1.3 Batch Receiver (B.8.1.3.1 – B.8.1.3.2)

Information: The “Batch Receiver” information identifies the receiver of the batch message.

ICSR Location: This information is located in the Batch Wrapper. It is captured in the <receiver>
class.

XML Details: The “Batch Receiver” of this batch transmission of AER reports is captured in the
<receiver> element. Currently, only an id is needed. The id value should be able to uniquely
identify the receiver.

The XPath to get “Batch Receiver” ID in the AER message is:

/MCCI_IN200100UV01/receiver/device/asAgent/representedOrganization/id

A sample XML snippet for “Batch Receiver” in the AER message is:

< MCCI_IN200100UV01>
<receiver>
<device determinerCode="INSTANCE" classCode="DEV">
<id/>
<asAgent classCode="AGNT">
<representedOrganization determinerCode="INSTANCE" classCode="ORG">

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VICH Step by Step Document

<id root="batch-receiver-identifier-id" extension="receiver organization name"/>

</representedOrganization>
</asAgent>
</device>
</receiver>
</MCCI_IN200100UV01>

4.1.4 Date of Batch Creation (B.8.1.4)

Information: The “Date of Batch Creation” indicates the date the batch report is created.

ICSR Location: This information is located in the Batch Wrapper. It is captured in the
<creationTime> element.

XML Details: The “Message Date” is captured using a simple TS data format. Please refer to
the Validation Procedure Document for more details regarding the date/time format and time
zone.

The XPath to get “Message Date” in the ISCR message is:

/MCCI_IN200100UV01/creationTime/@value

A sample XML snippet for “Message Date” in an AER message is:

< MCCI_IN200100UV01 ……>

……..
<creationTime value="20071016102030+0300"/>
……..
</MCCI_IN200100UV01>

4.1.5 VICH AER Version Number (B.8.1.5)

Information: The “VICH AER Version Number” indicates the AER Message Version and
Release Number on which this batch is based.

ICSR Location: This information is located in the Batch Wrapper. It is captured in the
<versionCode> element.

XML Details: Submitters should use the VICH AER version code. The initial version code is
“VICHAER1.0.0”.

The XPath to get “Version Information” in the AER message is:

/MCCI_IN200100UV01/versionCode/@code

A sample XML snippet for “Version Information” in an AER message is:

<MCCI_IN200100UV01>
<versionCode code="VICHAER1.0.0"/>
</MCCI_IN200100UV01>

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VICH Step by Step Document

4.2 Transmission Wrapper (Section B.8.2 – B.8.2.8)

This section contains data elements that will be captured with in the transmission wrapper of the
report

4.2.1 Message Number (B.8.2.1.1 – B.8.2.1.2)

Information: The “Message Number” information identifies the message. The concatenation of
Message Number Root and Extension uniquely identifies each message. The message creator
should ensure that this uniquely assigned identifier will never be used in another message. It is
the sender’s responsibility to define and assign this number, as each message should have a
unique number.

ICSR Location: This information is located in the HL7 Transmission Wrapper. It is captured in
the <id> of each message inside the batch being transmitted.

XML Details: The reporter should provide an ID inside <id> node. The <id> root attribute
(Message Number - Root) is the submitting organization’s unique “sender identifier”. The <id>
extension attribute (Message Number - Extension) contains the uniquely assigned message
identifier for the specified message (this is not the Unique Adverse Event Report Identification
Number). This field format is up to the creator of the message. The message creator should
ensure that this uniquely assigned identifier will never be used in another message.

The XPath to get the “Message Number” information in the AER message is:

/MCCI_IN200100UV01/PORR_IN049006UV/id/@extension

A sample XML snippet for “Message Number” in an AER message is:

<MCCI_IN200100UV01>
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
<id root="senders-safety-report-identifier-oid" extension="identifier"/>
</PORR_IN049006UV>
</MCCI_IN200100UV01>

4.2.2 Message Sender (B.8.2.2.1 - B.8.2.2.8)

Information: These data elements contain the organization name of the message sender who is
defined as the Pharmacovigilance Contact Person in charge of the AER message.

ICSR Location: This information is located in the HL7 Transmission Wrapper. It is captured in
the transmission wrapper sender class.

XML Details: The reporter should provide the person’s title, first name, last name, telephone
number, optional fax number, and e-mail address.

The XPath to get the “Pharmacovigilance Contact Person” in the AER message is:

/MCCI_IN200100UV01/PORR_IN049006UV/sender

A sample XML snippet for Pharmacovigilance Contact Person is:

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VICH Step by Step Document

<MCCI_IN200100UV01>
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
<sender typeCode="SND">
<device determinerCode="INSTANCE" classCode="DEV">
<id/>
<asAgent classCode="AGNT">
<representedOrganization determinerCode="INSTANCE" classCode="ORG">
<id root="message-sender-identifier-id" extension="sender organization name"/>
<notificationParty classCode="CON">
<id/>
<contactPerson>
<id/>
<name>
<prefix>Dr</prefix>
<given>Tom</given>
<family>Brown</family>
</name>
<telecom value="TEL:+1-123-4567890"/>
<telecom value="FAX:+1-123-4567891"/>
<telecom value="MAILTO:[email protected]"/>
</contactPerson>
</notificationParty>
</representedOrganization>
</asAgent>
</device>
</sender>
</PORR_IN049006UV>
</MCCI_IN200100UV01>

4.2.3 Message Receiver (B.8.2.3 – B.8.2.3.1)

Information: The “Message Receiver Root” is a field that contains the receiver of the AER
message, e.g., the MAH unique ID or RA unique ID.

ICSR Location: This information is located in the HL7 Transmission Wrapper. It is captured in
the receiver class.

XML Details: The reporter should provide an ID inside <receiver> node. The “Message Receiver
Root” is a field that contains the “message-receiver-identifier-id” of the message receiver.

The XPath to get the “Message Sender Identifier Telecom” information in the AER message is:

/MCCI_IN200100UV01/PORR_IN049006UV/receiver

A sample XML snippet for “Message Sender Identifier” in an AER message is:

< MCCI_IN200100UV01>
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
<receiver typeCode="RCV">
<device determinerCode="INSTANCE" classCode="DEV">
<id/>
<asAgent classCode="AGNT">
<representedOrganization determinerCode="INSTANCE" classCode="ORG">

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VICH Step by Step Document

4.2.4 Date of Message Creation (B.8.2.4)

Information: This is the date on which the message inside the batch was created. This date
may be the same as the date of batch creation.

ICSR Location: This information is located in the HL7 Transmission Wrapper. It is captured in
the <creationTime> in each message in the batch.

XML Details: The reporter should provide a date using a simple TS data format inside
<creationTime> node. Please refer to the Validation Procedure Document for more details
regarding the date/time format and time zone.

The XPath to get the “Date of Message Creation” information in the AER message is:

/MCCI_IN200100UV01/PORR_IN049006UV/creationTime/@value

A sample XML snippet for “Date of Message Creation” in an AER message is:

<MCCI_IN200100UV01>
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
<creationTime value="20120120102030+0300"/>
</PORR_IN049006UV>
</MCCI_IN200100UV01>

4.2.5 Report Identifier (B.8.2.5)

Information: This field is used for the sender to identify additional information that may be used
to process the information into their IT systems. Refer to Regional Annexes for additional
information.

ICSR Location: This information is located in the AER message Transmission Wrapper. It is
captured in an <attentionLine> node.

XML Details: Note that since multiple <attentionLine> nodes are used for different information,
users shall use an identification code in <keyWordText> element to identify this date element.

The XPath to get “Report Identifier” in the AER message is:

/MCCI_IN200100UV01/PORR_IN049006UV/attentionLine[keyWordText="Report Identifier"]/value

A sample XML snippet for “Report Identifier” in an AER message is:

<MCCI_IN200100UV01>
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">

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VICH Step by Step Document

<attentionLine>
<keyWordText>Report Identifier</keyWordText>
<value xsi:type="ST">N123123</value>
</attentionLine>
</PORR_IN049006UV>
</MCCI_IN200100UV01>

For regions where “Report Identifier” is not required, use the following snippet:

<MCCI_IN200100UV01>
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
<attentionLine>
<keyWordText>Report Identifier</keyWordText>
<value xsi:type="ST" nullFlavor="NI"/>
</attentionLine>
</PORR_IN049006UV>
</MCCI_IN200100UV01>

4.2.6 Domestic vs. Foreign Report Category (B.8.2.6)

Information: The “Domestic vs Foreign Report Category” indicates if the specified AER is a
domestic or foreign report relative to the receiver. Refer to Regional Annexes for additional
information.

ICSR Location: This information is located in the AER message Transmission Wrapper. It is
captured in an <attentionLine> node.

XML Details: Note that since multiple <attentionLine> nodes are used for different information, a
code must be used in <keyWordText> node to identify this data element. Users should use the
values from the Domestic vs. Foreign Report Categories vocabulary list.

The XPath to get “Domestic vs Foreign Report Category” in the AER message is:

/MCCI_IN200100UV01/PORR_IN049006UV/attentionLine[keyWordText="Domestic vs Foreign Report

Category"]/value

A sample XML snippet for “Domestic vs Foreign Report Category” in an AER message is:

<MCCI_IN200100UV01>
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
<attentionLine>
<keyWordText>Domestic vs Foreign Report Category</keyWordText>
<value xsi:type="SC" codeSystem="2.16.840.1.113883.13.212" displayName="Domestic" code="C62264"/>
</attentionLine>
</PORR_IN049006UV>
</MCCI_IN200100UV01>

For regions where “Domestic vs Foreign Report Category” is not required, use the following snippet:

<MCCI_IN200100UV01>
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
<attentionLine>

4-7 November 05, 2014

VICH Step by Step Document

<keyWordText>Domestic vs Foreign Report Category</keyWordText>

4.2.7 Profile Identifier (B.8.2.7)

Information: The “Profile Identifier (Profile ID) Code” contains details about the type of report
contained in this message payload. When creating the message, the value for this field should be
from the Profile Identifier Vocabulary list. Refer to Regional Annexes for additional information.

ICSR Location: This information is located in the AER message Transmission Wrapper. It is
captured in the <profileId> node. The actual value is set in its extension attribute.

XML Details: The XPath and snippet for the data element are below.

The XPath to get the “Profile ID” element within the AER message is:

/MCCI_IN200100UV01/PORR_IN049006UV/profileId/@extension

A sample XML snippet for “Profile ID” in an AER message is:

< MCCI_IN200100UV01>
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
<profileId root="2.16.840.1.113883.13.207"
extension="AES.FDA.VICHGL42.M.V1.ACCOUNT.AE"/>
</PORR_IN049006UV>
</MCCI_IN200100UV01>

For regions where “Profile ID” is not required, use the following snippet:

< MCCI_IN200100UV01>
<PORR_IN049006UV xsi:type="PORR_IN049006UV.MCCI_MT000100UV01.Message">
<profileId nullFlavor="NI"/>
</PORR_IN049006UV>
</MCCI_IN200100UV01>

4-8 November 05, 2014

VICH Step by Step Document

5 List of Abbreviations
Abbreviation Description
AE Adverse Event
AER Adverse Event Report
Anatomical Therapeutic Chemical classification system for veterinary medicinal
ATC Vet Code
products
CVM Center for Veterinary Medicine
EMA European Medicines Agency
FDA US Food and Drug Administration
HL7 Health Level 7 Organization
ICSR HL7 Individual Case Safety Report format
ISO International Standards Organization
MAH Marketing Authorization Holder
OID Object Identifier
Payload The XML message organizational structure that contains the AER
RA Regulatory Authority
International Cooperation on Harmonization of Technical Requirements for
VICH
Registration of Veterinary Medicinal Products
VMP Veterinary Medicinal Product
XML Extensible Markup Language
XPath An XML method to locate specific elements within an XML document

5-1 November 05, 2014

VICH Step by Step Document

6 RA to MAH, RA to RA, and MAH to MAH Snippets

Example for a case sent from a RA to a MAH

In this case the receiver section in the XML is Section VICH A.1 RA. The sender (author)
section in the XML is Section VICH A.2 MAH

<subjectOf1 typeCode="SUBJ">
<controlActEvent classCode="CACT" moodCode="EVN">
<author typeCode="AUT">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.193" code="T95009" displayName="RA"/>
<addr use="WP">
<streetAddressLine> 7 Westferry Circus Canary Wharf </streetAddressLine>
<city>London</city>
<state/>
<postalCode>E14 4HB </postalCode>
<country>GBR</country>
</addr>
<representedOrganization determinerCode="INSTANCE" classCode="ORG">
<name>European Medicines Agency </name>
<contactParty classCode="CON">
<telecom value="TEL:+44-20-7418-8400"/>
<telecom value="FAX:+44-20-7418-8599"/>
<telecom value="MAILTO:[email protected]"/>
<contactPerson determinerCode="INSTANCE" classCode="PSN">
<name>
<prefix>Dr</prefix>
<given>Tom</given>
<family>Brown</family>
</name>
</contactPerson>
</contactParty>
</representedOrganization>
</assignedEntity>
</author>
<primaryInformationRecipient typeCode="PRCP">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.193" code="T95001" displayName="MAH"/>
<addr use="WP">
<streetAddressLine> Building MON 6700 </streetAddressLine>
<city>Leverkusen</city>
<state>NRW</state>
<postalCode>51368</postalCode>
<country>DEU</country>
</addr>
<representedOrganization determinerCode="INSTANCE" classCode="ORG">
<name>Company Animal Health GmbH</name>
</representedOrganization>
</assignedEntity>
</primaryInformationRecipient>
</controlActEvent>
</subjectOf1>

6-1 November 05, 2014

VICH Step by Step Document

Example for a case sent from a RA to a RA

In this case the receiver section in the XML is Section VICH A.1 RA. The sender (author)
section in the XML is also RA, Section VICH A.1 RA.

<subjectOf1 typeCode="SUBJ">
<controlActEvent classCode="CACT" moodCode="EVN">
<author typeCode="AUT">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.193" code="T95009" displayName="RA"/>
<addr use="WP">
<streetAddressLine> 7 Westferry Circus Canary Wharf </streetAddressLine>
<city>London</city>
<state/>
<postalCode>E14 4HB </postalCode>
<country>GBR</country>
</addr>
<representedOrganization determinerCode="INSTANCE" classCode="ORG">
<name>European Medicines Agency </name>
<contactParty classCode="CON">
<telecom value="TEL:+44-20-7418-8400"/>
<telecom value="FAX:+44-20-7418-8599"/>
<telecom value="MAILTO:[email protected]"/>
<contactPerson determinerCode="INSTANCE" classCode="PSN">
<name>
<prefix>Dr</prefix>
<given>Tom</given>
<family>Brown</family>
</name>
</contactPerson>
</contactParty>
</representedOrganization>
</assignedEntity>
</author>
<primaryInformationRecipient typeCode="PRCP">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.193" code="T95009" displayName="RA"/>
<addr use="WP">
<streetAddressLine>Paul-Ehrlich-Strasse </streetAddressLine>
<city>Langen</city>
<state>Hessen</state>
<postalCode>63225</postalCode>
<country>DEU</country>
</addr>
<representedOrganization determinerCode="INSTANCE" classCode="ORG">
<name>Paul-Ehrlich-Institut</name>
</representedOrganization>
</assignedEntity>
</primaryInformationRecipient>
</controlActEvent>
</subjectOf1>

6-2 November 05, 2014

VICH Step by Step Document

Example for a case sent from a MAH to a MAH

In this case the receiver section in the XML is Section VICH A.1 MAH. In this case the sender
(author) section in the XML is also RA Section VICH A.1 MAH

<subjectOf1 typeCode="SUBJ">
<controlActEvent classCode="CACT" moodCode="EVN">
<author typeCode="AUT">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.193" code="T95001" displayName="MAH"/>
<addr use="WP">
<streetAddressLine> B Street 123 </streetAddressLine>
<city>London</city>
<state/>
<postalCode>E14 4HB </postalCode>
<country>GBR</country>
</addr>
<representedOrganization determinerCode="INSTANCE" classCode="ORG">
<name>Company Pet Health GmbH </name>
<contactParty classCode="CON">
<telecom value="TEL:+44-20-1234-5678"/>
<telecom value="FAX:+44-20-1234-8765"/>
<telecom value="MAILTO:[email protected]"/>
<contactPerson determinerCode="INSTANCE" classCode="PSN">
<name>
<prefix>Dr</prefix>
<given>John</given>
<family>Doe</family>
</name>
</contactPerson>
</contactParty>
</representedOrganization>
</assignedEntity>
</author>
<primaryInformationRecipient typeCode="PRCP">
<assignedEntity classCode="ASSIGNED">
<code codeSystem="2.16.840.1.113883.13.193" code="T95001" displayName="MAH"/>
<addr use="WP">
<streetAddressLine> Building 1234 </streetAddressLine>
<city>Leverkusen</city>
<state>NRW</state>
<postalCode>51368</postalCode>
<country>DEU</country>
</addr>
<representedOrganization determinerCode="INSTANCE" classCode="ORG">
<name>Company Animal Health GmbH</name>
</representedOrganization>
</assignedEntity>
</primaryInformationRecipient>
</controlActEvent>
</subjectOf1>

6-3 November 05, 2014

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PhVVICH-StepByStepGuide_Final 20141105 002

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PhVVICH-StepByStepGuide_Final 20141105 002

Uploaded by

International Cooperation on Harmonization of Technical

Requirements for Registration of Veterinary Medicinal Products

Electronic Submission of Animal Adverse Events

Electronic Transmission Implementation Specifications

November 05, 2014

The contents within this document are based on ISO 27953-1.

Document Change Record

ii November 05, 2014

iii November 05, 2014

3.7.2 Attached Document Type – GL42 Section B.7.1.1 ............................................................ 3-45

iv November 05, 2014

1.1 VICH GL42

1.2 AER Documents

Table 1-1 AER Documents

1-1 November 05, 2014

1.3 Document Structure

 Defined AER data element names and element reference values

1.4 Structure of AER Submission Message

Figure 1-1 Sample AER Submission Format

1-2 November 05, 2014

Control Act Wrapper

Transmission Wrapper Message 2

Control Act Wrapper

Transmission Wrapper Message n

Control Act Wrapper

1-3 November 05, 2014

Figure 1-2 Sample XML AER Batch Submission

1.5 Exceptions to Be Noted

1-4 November 05, 2014

In a batch message, the XPath to get “Type of Submission” is:

Entity Reference Character

<value xsi:type="CE" codeSystem="2.16.840.1.113883.13.50" code="C82440" displayName="&lt;12 hours"/>

1.6 Special Handling of Element Fields (Null Flavors)

Fully Compliant XML Snippet

1-5 November 05, 2014

<observation classCode="OBS" moodCode="EVN">

Fully Compliant Null Flavor XML Snippet

Table 1-2 Null Flavor Element Data Rules

1-6 November 05, 2014

Element Type Null Flavor Rule

1.7 XML Locator Codes

The following table contains the list of locator codes.

Table 1-3 XML Locator Codes

1-7 November 05, 2014

1.8 Rules Concerning Handling Responses Within Elements

1.9 Vocabulary Reference List of Values

1.10 MAH to RA Message

1-8 November 05, 2014

2 Administrative and Identification Information – GL42

Table 2-1 Regulatory Authority Information

ICSR Location: RA information is located in the message payload

XML Details: RA information is captured using <assignedEntity> element as shown in the

2-1 November 05, 2014

<controlActEvent classCode="CACT" moodCode="EVN">

2.2 Marketing Authorization Holder (MAH) (Sender) – GL42 Section A.2

2-2 November 05, 2014

Table 2-2 Telecom Entry Format Rules

2-3 November 05, 2014

2.3 Person(s) Involved in AER (Reporter) – GL42 Section A.3 (A.3.1 –

<investigationEvent classCode="INVSTG" moodCode="EVN">

2-4 November 05, 2014

2.4 AER Information (Investigation/Report Information) – GL42 Section

 A.4.1 Unique Adverse Event Report Identification Number

2-5 November 05, 2014

<investigationEvent moodCode="EVN" classCode="INVSTG">

2.4.2 Original Receive Date – GL42 Section A.4.2

ICSR Location: This information is located in the AER message payload

2-6 November 05, 2014

2.4.3 Date of Current Submission – GL42 Section A.4.3

<investigationEvent classCode="INVSTG" moodCode="EVN">

2.4.4 Type of Report – GL42 Section A.4.4

2.4.4.2 Reason for Nullification

ICSR Location: Same as “Type of Submission”.

The XPath to get “Type of Submission” in the AER message is:

2-7 November 05, 2014

<investigationEvent moodCode="EVN" classCode="INVSTG">

<value xsi:type="CE" codeSystem="2.16.840.1.113883.13.50" code="C82440" displayName="<12 hours"/>