MOHAP e-Transformation

Certificate of Pharmaceutical Products (CPP) - External User

Guide

Date: 11th April 2019

 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

Table of Contents

1. Brief Overview ............................................................................................................... 3

2. Apply for Service ........................................................................................................... 3

2.1 Create a New Application ........................................................................................ 4

2.2 CPP Application ....................................................................................................... 5

2.2.1 Product Details ................................................................................................. 6

2.2.2 Pack Details ...................................................................................................... 8

2.2.3 CPP Details ....................................................................................................... 9

2.2.4 Attachments ................................................................................................... 10

2.3 Review Application ................................................................................................ 11

2.4 Checkout .............................................................................................................. 12

3. Take Required Actions ................................................................................................. 13

3.1 Application Correction........................................................................................... 14

4. Printouts ..................................................................................................................... 15

5. Appendix..................................................................................................................... 18

5.1 Appendix I ............................................................................................................ 18

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 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

1. Brief Overview
This manual is prepared to navigate applicants through the process of issuing the Certificate
of Pharmaceutical Products (CPP) for product packs in Ministry of Health and Prevention
(MOHAP) Portal.

This manual is designed to help applicants:

 Apply for a Certificate of Pharmaceutical Products (CPP) for their medical products
 Manage Certificate of Pharmaceutical Products (CPP) applications
After completing this manual, the applicant should be able to perform all activities related to
CPP on MOHAP Portal.

Please note: This service is only available to the Applicants listed below.

Applicant Type Rules

Should have un-expired license

Agents Can only issue CPP for drugs registered under his name as
agent
Should have un-expired license
Scientific Offices Can only issue CPP for drugs registered under his name as
Applicant or MAH
Should have un-expired license
Can only issue CPP for drugs they (Manufacturer) are a part of
Local Manufacturers
in the manufacturing cycle

TABLE 1: TYPES OF APPLICANTS

2. Apply for Service

Portal users who have logged in successfully to MOHAP portal will be directed to Dashboard
screen where they can apply to MOHAP’s e-services. This user manual will focus on the CPP
service.

For applicants to apply to their available services, they must go through the following
process:

1. Create a new application

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 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

2. Complete application
3. Review application
4. Proceed to checkout
The sections below will help user through the step-by-step process of applying to an
application.

Create a New
Application

FIGURE A: DASHBOARD SCREEN

2.1 Create a New Application

The Applicant can request to classify their products based on MOHAP standards by:

Requesting to create a New Application form from the Applicant Portal and selecting the
following service which falls under the Drug Certificates services:

 Certificate of Pharmaceutical Products (CPP)

To create a new application form from the Applicant Portal, the user must do the following:

a. Click on one of the New Application buttons found on the Dashboard Screen (or All
Applications Screen) – which opens New Application Screen
b. Select Certificate of Pharmaceutical Products (CPP)

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 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

c. Click Create Application button

Once the user selects Certificate of Pharmaceutical Products (CPP) as a service and creates an
application, the user will be redirected to Product Details screen.

Create a New
CPP Application

FIGURE B: NEW APPLICATION SCREEN

2.2 CPP Application

To complete a Drug Classification application, the applicant must fill the following three
sections:

1. Product Details
2. Pack Details
3. CPP Details
4. Attachments
At any application stage, the applicant can perform the following actions:

 Save application
 Discard application
 Proceed to next section
 Go back to previous section
For an applicant to move from one section to another, they are required to fill the section’s
mandatory fields and tables.

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 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

FIGURE C: PROGRESS BAR

Warnings:
 In case the applicant did not complete a mandatory filed, a warning message marked
in red will be displayed under the field text box highlighting the note: This Field is
Required.
 In case the applicant did not fill a table, a warning message marked in red will be
displayed under the table box highlighting the note: Table Cannot be empty.
 In case the applicant inputs a non-numeric character in a field that only accepts
numbers, a warning message marked in red will be displayed under the field text box
highlighting the note: This field accepts numbers only.
Display icons:

 allows user to Delete data (usually found under Actions)

 allows user to Edit data (usually found under Actions)

Tips: Each application section will contain a progress bar that shows the input progress of the
application data

2.2.1 Product Details

In the Product Details screen, the applicant is required to search and select the Medical
Product's Name / Trade Name. Consequently, the screen will display the product details
along with the pack list for the product selected.

To proceed with CPP request, the applicant must click on icon under Registered Packs to
proceed to the Pack Details screen.

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MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

Click to
Proceed

FIGURE D: PRODUCT DETAILS SCREEN

Rule ID Rules
R1 The selected pack's MAH Country should be UAE.
The selected pack should be partially/fully manufactured in UAE, i.e. if it’s
manufactured by one manufacturer, its country should be UAE, and if there
R2
are many manufacturers, at least one of them, its country should be UAE.

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Rule ID Rules
The selected pack's Product Class should not be Medical Device.
R3

R4 Pack registration should be non-expired.

FIGURE E: PRODUCT DETAILS RULES

2.2.2 Pack Details

The Pack Details section is broken down into many subsections, each containing essential
details of the registered pack. Below are the following subsections:

a. General Information
b. Package Insert Details
c. Product Form
d. Active Ingredients*
e. Inactive Ingredients*
f. Routes List
g. Market Authorization Holder
h. PV Officer*
i. Target Animals**
j. GCC Registration
k. Registration Status Country of Origin
l. Registration Status Other Countries
m. Patent Status
n. Pack Sizes
o. Additional Information (Optional)

The landing page of the Pack Details section is the General Information sub-section. To
proceed to the next screen, please proceed to click on the Next button.

Please note: This fields/attachments in this section are Read-Only.

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 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

Click to
Proceed

FIGURE F: PACK DETAILS SCREEN

2.2.3 CPP Details

For the applicant to proceed with the CPP request, they are required to provide the following
information:

a. Exporting Name
b. Exporting Country
c. Importing Country

Once the applicant provides the section’s required information, they can move to the next
section by clicking the Next button.

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Click to
Proceed

FIGURE G: CPP DETAILS SCREEN

2.2.4 Attachments

This section is where an applicant can upload General Attachments before proceeding to
submit the application. Below are the attachments the applicant must submit before moving
to the next section:

Documents
Insert which is last approved by MOHAP to be Signed by Authorized Person.
Original Composition Certificate signed by Authorized Person.
Table 2: List of Attachments

The user can add more attachments to their CPP application by performing the following:

1. Enter the Document Name

2. Click the Add Attachment icon
3. Upload Attachment
Once the applicant is done with this section, they can move to the Review section by clicking
Review button.

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 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

Click to
Proceed

Figure H: Attachments Screen

2.3 Review Application

After the applicant completes filling all application details, they must click on the Review
button to proceed with application submission. The Review section provides a full summary
of the application and allows the user to perform the following actions:

 Edit Application
 Save Application
 Discard Application
 Go Back to Previous Section
 Read & Accept General Terms & Conditions
 Submit Application

Once the applicant reviews application and accepts the General Terms and Conditions, they
must click the Submit button to proceed to checkout.

Please note: to proceed with application submission, the applicant must read & accept the
General Terms and Conditions.

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Warning: In case the user did not fill all mandatory fields, a warning message will be displayed
noting that applicant must fill all required fields before submitting the application.

Display icon:

 allows user to Edit application details

 allows user to view table

Click to
Submit

Figure I: Review Screen

2.4 Checkout

After an application has been submitted, the applicant will be redirected to Checkout screen
where they will be asked to pay the following:

 Application Fees: AED 1000 per Application

To proceed with payment, the applicant must click on the Checkout button shown at the
bottom-right corner of the Checkout screen which will redirect the applicant to MOHAP’s
Payment Gateway (e-dirham).

Tip: Overrun Pop-up Blocker to open MOHAP’s Payment Gaterway (e-dirham)

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 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

Click to
Checkout

Figure J: Checkout Screen

3. Take Required Actions

Once an application has been reviewed by a MOHAP officer, the officer might request the
applicant to take actions before proceeding with application. The applicant will get notified
via SMS or email once the officer requires an action.

For a user to view and take these actions, they must:

a. Click on the Application Number in All Applications screen – which redirects user to
Submitted Application screen
b. Click on Required Actions tab
c. Click on the Action – which opens an Action window

Take
Required
Actions

Figure K: Submitted Application Screen

The request the officer can ask an applicant is the following:

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 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

1. Application Correction
This action will be explained in detail in the following sections.

3.1 Application Correction

In case a MOHAP officer identifies fields/attachments in application that require modification,

the officer will send back the application to applicant for correction as part of the Drug
Classification reviewing process.

For the applicant to view and change the fields/attachments that require correction, the
applicant must:

a. Click on Correction button found in Required Actions tab – which redirects applicant
to Correction screen
b. Make changes to fields/attachments*
c. Add comment in Comment box
d. Click on Submit Correction button
e. Confirm correction
Once the applicant confirms correction, the application will be sent back to officer for further
review.

Rule: *Only fields/attachments needed for correction are displayed for change

Click to
Proceed with
Correction

Figure L: Submitted Application Screen – Required Actions

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 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

Figure M: Field Correction Cursor

Figure N: Modified Field Figure O: Unmodified Field

Click to
Submit
Correction

Figure P: Correction Screen

Display icons: allows the user to undo change

Tips:
i. Field Correction Tool helps user navigate from one unsolved request to another
ii. Fields required for change are highlighted in Red
iii. Modified fields are highlighted in Yellow.

4. Rejected Applications
Once an application has been rejected by a MOHAP Officer, an email or an SMS will be sent
to the applicant containing the application’s latest updates and results.

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To view the rejection comments given by MOHAP Officer and the step at which the
application got rejected, please click on the Application History button.

Figure Q: Application History

To resubmit a rejected application, please perform the following actions:

a. Click on icon shown in the All Applications screen (or Submitted Application screen)
– which redirected to Patient Details screen
b. Make changes based on MOHAP Officer’s rejection comments
c. Proceed to submit application

Resubmit
Application
View
Application
History

Figure R: Submitted Application Screen – Application Details

5. Printouts
Once an application has been reviewed and approved by a MOHAP officer, the officer will issue
the applicant a Certificate associated with the service type. The applicant will get notified via
SMS or email once the officer issues the certificate.

For a user to view and printout a certificate, they must:

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 MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

a. Click on the Application Number in All Applications screen – which redirects user to
Submitted Application screen
b. Click on the Certificate tab
c. Click on the Attachment – which opens the certificate as a PDF
d. Print PDF

Open
Certificates
Tab

Figure S: Submitted Application Screen – Printout

The issued certificates will have a validity of 2 year or up to product registration expiry date
in case product registration validity is less than 2 years.

The Certificate of Pharmaceutical Products (CPP) will contain the information shown in
Appendix I.

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MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

6. Appendix
6.1 Appendix I

Fields
Certificate No.
1. Exporting (certifying) Country
Importing (requesting) Country
Exporting Name and Dosage Form
Active Ingredient (Multiple Records)
 Ingredient
 Quantity
Inactive Ingredient (Multiple Records)
 Ingredient
 Quantity
1.2 Whether this licensed product is to be placed on the market for use in the
exporting country?

1.3 Whether this product actually on the market in the exporting country?

In case of ‘Yes’ option of # 1.2, below In case of ‘No’ option of # 1.2; below
fields are displayed fields are displayed

2.A.1 Number of product license and

2.B.1 Applicant for Certificate
date issue
License/ Registration Number · Applicant Name
Date of Issue · Address
2.A.2 Product-license holder Name · City
Name · Country
Address 2.B.2 Status of Applicant
City a. Manufactures the dosage form
b. Packages and/or labels a dosage
Country from manufactured by an independent
company
2.A.3 Status of Product License Holder c. Is involved in none of the above

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MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

Fields
2.B.2.1 For categories ‘b’ and ‘c’ the
a. Manufactures the dosage form name and address of the manufacturer
producing the dosage form are
b. Packages and/or labels a dosage
from manufactured by an independent Name of Manufacturer
company
c. Is involved in none of the above Address
2.A.3.1 For categories ‘b’ and ‘c’ the
name and address of the manufacturer City
producing the dosage form are
Name of Manufacturer Country
2.B.3 Why is marketing authorization
Address
lacking?
City 2.B.4 Remarks
3. Does the certified authority arrange
for periodic inspection of the
Country
manufacturing plant in which the
dosage form is produced.
2.A.4 Is the summary basis of approval In Case of ‘Yes’ Option of 3, below
appended? fields are displayed
2.A.5 Is the attached officially approved
3.1. Periodicity of routine inspection
product information, complete and
(Years)
consonant with the license?
2.A.6 Applicant for certificate, if 3.2. Has the manufacture of this type of
different from license holder dosage form been inspected?
3.3 Do the facilities and operations
confirm to GMP as recommended by
World Health.
4. Does the information submitted by
the applicant satisfy the certifying
authority on all aspects of the
manufacture of the product?
4.1 If No Explain
Pharmaceutical Particulars

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MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

Fields
Product class
Date of First Registration
Shelf Life (Months)
Storage Condition Description
Pack Size (Multiple Records)
Pack Size
Dispensing Mode
Name of Authorized Person
Date of Issue
Date of Expiry
Address of Certifying Authority
In Case of ‘Yes’ Option of 3, below
fields are displayed
3.1. Periodicity of routine inspection
(Years)
3.2. Has the manufacture of this type of
dosage form been inspected?
3.3 Do the facilities and operations
confirm to GMP as recommended by
World Health.
4. Does the information submitted by
the applicant satisfy the certifying
authority on all aspects of the
manufacture of the product?
4.1 If No Explain
Pharmaceutical Particulars
Product class
Date of First Registration
Shelf Life (Months)
Storage Condition Description
Pack Size (Multiple Records)
Pack Size
Dispensing Mode
Name of Authorized Person

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MOHAP e-Transformation - Certificate of Pharmaceutical Products (CPP) - User Guide

Fields
Date of Issue
Date of Expiry
Address of Certifying Authority
Table 3: Certificate Fields

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