Version 1.

0
 GCC Guideline on the
specifications for provision of an
electronic submission for a
veterinary medicinal product

Version 1.0

Central Registration

Please visit the GHC website

for the latest updates

For Inquiries [email protected]

[email protected]

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Document Control

Version Author Date Comments

Veterinary Products First draft

1.0 8 November 2015
Licensing

Veterinary Products Second draft

2.0 8 January 2017
Licensing
Add CC in samples,
Executive Directorate 1-responses, 1a51
of Regulatory Affairs and 1a52.
3.0 14 April 2019 Remove of
procedure type in
Annex.

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TABLE OF CONTENTS

1 INTRODUCTION .......................................................................................................................... 7
1.1. BACKGROUND ............................................................................................................................. 8
1.2. SCOPE ............................................................................................................................................. 8
1.3. FUNCTIONAL REQUIREMENTS .............................................................................................. 8
1.4. CHANGE CONTROL ................................................................................................................... 8
1.5. GLOSSARY AND DEFINITION ................................................................................................. 9
2 GCC VETERINARY SUBMISSION ......................................................................................... 10
2.1. GENERAL CONSIDERATIONS ............................................................................................... 10
2.1.1 PROCEDURES FOR SENDING ELECTRONIC INFORMATION ................................. 10
2.1.2 LANGUAGE ............................................................................................................................ 10
2.1.3 FILE FORMAT ....................................................................................................................... 10
2.1.4 VERSION ................................................................................................................................. 11
2.1.5 FILE SIZE ............................................................................................................................... 11
2.1.6 METHODS FOR CREATING PDF DOCUMENTS AND IMAGES................................. 12
2.1.6.1 ELECTRONIC SOURCE DOCUMENTS ....................................................................... 13
2.1.6.2 BOOKMARKS AND HYPERTEXT LINKS ................................................................... 14
2.1.6.3 FONTS ................................................................................................................................. 14
2.1.6.4 PAGE NUMBERING ......................................................................................................... 15
2.1.6.5 OPEN DIALOG BOX ......................................................................................................... 15
2.1.6.6 USE OF ACROBAT PLUG-INS ....................................................................................... 15
2.1.6.7 HARD MEDIA (CD/DVD) ................................................................................................. 15
2.1.7 CORRESPONDENCE ............................................................................................................ 16
2.2. TECHNICAL INFORMATION ................................................................................................. 17
2.2.1. USE OF ELECTRONIC SIGNATURES .......................................................................... 17
2.2.2. SECURITY ISSUES ........................................................................................................... 17
2.2.3. VIRUS PROTECTION ...................................................................................................... 17
2.2.4. PASSWORD PROTECTION ............................................................................................ 17
2.3. GENERAL ARCHITECTURE OF VETERINARY SUBMISSION ....................................... 18
2.3.1. DIRECTORY / FILE STRUCTURE ................................................................................ 18
2.3.2. GRANULARITY ................................................................................................................ 18
2.3.3. FILE NAMING CONVENTION ....................................................................................... 21
2.3.4. ADAPTATION OF FOLDER STRUCTURE .................................................................. 22
2.3.5. TABLES OF CONTENTS: ELECTRONIC VETERINARY DOSSIER ...................... 23
2.3.6. FOLDER NAMES .............................................................................................................. 26
2.3.7. FOLDER STRUCTURE FOR INITIAL MAA ................................................................ 26

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2.3.8. USE OF SUMMARY REPORTS IN MRL DOSSIER .................................................... 26
2.3.9. SUBMISSION STRUCTURE FOR UPDATES DURING ASSESSMENT PHASE ..... 26
2.3.10. VALIDATION UPDATES ................................................................................................. 26
2.3.11. RESPONSES TO QUESTIONS ........................................................................................ 27
APPENDIX 1: EXAMPLE SCREENSHOT .................................................................................................. 28
APPENDIX 2: DIRECTORY/FILE STRUCTURE FOR PART 1 ..................................................................... 32
APPENDIX 3: LIST OF CODES ................................................................................................................ 34

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1 Introduction

This document specifies provision of an electronic submission (e-submission) for a

veterinary medicinal product; This Guidance Document is intended to assist applicants
and regulators with submissions of dossiers in electronic format. It specifies the basic
parameters required for an acceptable electronic submission.

This document is conformed to the recommendation of VICH for the harmonisation of

the technical requirements for veterinary product registration.

The objectives of the VICH are along the same lines as those of the ICH. The VICH
will:
• Establish and implement harmonized technical requirements for the registration
of veterinary medicinal products in the VICH regions, which meet high quality,
safety and efficacy standards and minimize the use of test animals and costs of
product development.
• Provide a basis for wider international harmonization of registration
requirements.
• Monitor and maintain existing VICH guidelines, taking particular note of the
ICH work program and, where necessary, update these VICH guidelines.
• Ensure efficient processes for maintaining and monitoring consistent
interpretation of data requirements following the implementation of VICH
guidelines.
• Ensure efficient processes for maintaining and monitoring consistent
interpretation of data requirements following the implementation of VICH
guidelines.
• By means of a constructive dialogue between regulatory authorities and industry
provide technical guidance enabling response to significant emerging global
issues and science that impact on regulatory requirements within the VICH
regions.

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1.1. Background
The VICH guidelines on the technical requirements for marketing authorization
applications for veterinary medicinal products are developed by expert working groups
comprising experts from the different VICH members, from the observers and from
VICH Outreach Forum countries on the topics identified by the VICH Steering
Committee in a consultative process.

1.2. Scope
This guidance covers all types of initial veterinary applications for marketing
authorization made in the GCC and National procedures including updates provided
during the assessment phase (validation updates and responses to questions).

For notifications submitted regarding the deliberate release of a Genetically

Modified Organism (GMO), it is advisable to confirm acceptance of an e-submission
with the concerned national agency in GCC.

1.3. Functional Requirements

The specification is designed to support high-level functional requirements such as
the following:

• Copying and pasting

• Viewing and printing of documents
• Annotation of documentation
• Facilitating the exporting of information to databases
• Searching within and across applications
• Navigating throughout the submission and its subsequent
amendments/variations

1.4. Change Control

The specification for the submission is likely to change with time. Factors that
could affect the content of the specification include, but are not limited to:

• Identification of new functional requirements

• Experience of use of the veterinary submission by all parties

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1.5. Glossary and Definition
A brief glossary of terms (for the purpose of this document only) is indicated below:

APPLICANT A pharmaceutical company or its agent that is submitting

information in support of an application.
APPLICATION A collection of documents compiled by a pharmaceutical
company or its agent in compliance with guidelines in order to
seek a marketing authorization or any amendments thereof.
CCITT Consultative Committee for International Telephony and
Telegraphy
CD/DVD Compact Disc / Digital Versatile Disc or Digital Video Disc
DACS Detailed and Critical Summaries
DPI Dots per inch
ERA Environmental Risk Assessment
GCC Gulf Cooperation Council
GIF Graphics Interchange Format
GMO Genetically Modified Organism
GTOC General Table of Contents
HARD MEDIA Any type of physical media used for storage and transfer of
electronic data (e.g. optical media like CDs or DVDs) in contrast
to a purely electronic transfer e.g. via any web portal.
ICH The International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use
ISO International Organization for Standardization
JPEG Joint Photographic Experts Group
MAA Marketing Authorization Application
MathML Mathematical Markup Language
MB Megabytes
MRL Maximum Residue Limit
OCR Optical Character Recognition
PDF Portable Document Format
PNG Portable Network Graphics
PROCEDURE A registration procedure for the authorization of medicinal
products
RGB Red Green Blue
RTF Rich Text Format
SmPC/SPC Summary of Product Characteristics
SVG Scalable Vector Graphics
TIFF Tagged Image File Format
TOC Table of Contents
URA User Risk Assessment

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VICH International Cooperation on Harmonization of Technical
Requirements for Registration of Veterinary Medicinal Products.

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2 GCC VETERINARY SUBMISSION

This document describes the specific information that is common to all veterinary
submissions in the Gulf Cooperation Countries.

2.1. General Considerations

2.1.1 Procedures for sending electronic information
There are different ways of submitting electronic dossiers to competent authorities,
including portals, or hard media (CD/DVD), if accepted by authorities. Normally, only
one way should be used, to avoid sending multiple copies of the same submission to the
authority.
Competent authorities will not accept any hardware (laptops, desktops, etc.) or software
from applicants in connection with the submission of information in an electronic format.
The electronic information should be directly readable and usable on the competent
authorities’ hardware (e.g. CD/DVD drive) and software. Authorities may require
provision of a paper cover letter for electronic submissions.
An electronic version of a cover letter should always be included in the folder “add-
info” of the veterinary submission (PDF preferably generated from text source without a
requirement to scan a wet signature).

For authorities requiring an official signature for legal reasons, an originally signed
cover letter or application form may accompany or follow the electronic submission.

2.1.2 Language
In order to facilitate the processing of the application and make the assessment more
efficient, the scientific and technical documentation should be submitted in English.
Both applicants and authorities should refrain from translations to languages other than
English as this makes quality control and validation difficult and less reliable.
2.1.3 File Format
All documentation should be submitted using file formats that facilitate both reviews on
screen and paper while retaining a similar format.
The portable document format (PDF) is a format which supports the described features.
PDF provides an ISO-standardised format (ISO 32000-1:2008), including a long-term
archiving format also known as PDF/A (ISO-19005-1:2005, ISO-19005-2:2011 and
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ISO-19005-3:2012). PDF has been accepted as a standard for providing documents in
electronic format by the International Council for Harmonisation (ICH) and is
recommended as default file format by the veterinary equivalent (VICH).

Table 1: Acceptable file formats for GCC veterinary submissions

Document File Format Remark

Administrative forms: Documents should be generated
• Application form and its PDF from electronic source documents,
annexes any signature may be embedded as
• Variation application form PDF graphic file in the PDF text if
incl. background for the desired, although this is not
variation necessary as the hard paper copy
• Renewal form and its PDF contains the legally binding
annexes signature.
Product Information: If a higher resolution is necessary
for the mock-ups, use JPEG, GIF,
• Labeling text PNG or SVG on a case-by-case
PDF
• Packaging mock-ups basis.
PDF
• Reference to Specimens In that context, images can be
PDF
• Readability Testing PDF
transmitted in JPEG, GIF, PNG,
• Information relating to TIFF, SVG, or MathML.
PDF
Orphan Applications
PDF preferably generated from
Other PDF
electronic source

Although the use of the file formats defined in Table 1 are mandatory, regulatory
authorities and applicants could agree on the use of other formats for content provided
outside of the VNeeS in the “add-info” folder. For example, proprietary format MS
Word for Product Information documents. These documents (SPC, label, and leaflet)
should normally be provided in addition to the PDF versions.
2.1.4 Version
The PDF format used for a submission should be legible with Acrobat Reader, version
5.0 or higher.
All regional regulatory authorities are able to read and accept PDF files saved as PDF
version 1.4 through 1.7, PDF/A-1, or PDF/A-2 compliant to ISO 32000-1:2008.
Regulatory authorities should not need any additional software to read and navigate the
PDF files. No PDF documents should be in version PDF 1.3 or earlier.
2.1.5 File Size
The file size of a single file should be limited to 100 MB.
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2.1.6 Methods for Creating PDF Documents and Images
Adobe Portable Document Format (PDF) is a published format created by Adobe
Systems Incorporated (http://www.adobe.com). It is not necessary to use a product from
Adobe or from any specific company to produce PDF documents.
PDF is accepted as a standard for documents defined in this specification. The following
recommendations support the creation of PDF files that agencies can review effectively.
To ensure that PDF files can be accessed efficiently, Optimize PDF files for fast web
view.

The method used for creating PDF documents should produce the best replication of a
paper document. To ensure that the paper and PDF version of the document are the
same, the document should be printed from the PDF version. Documents that are
available only in paper should be scanned at resolutions that will ensure the pages are
legible both on the computer screen and when printed. At the same time, the file size
should be limited. It is recommended that scanning be undertaken at a resolution of 300
dots per inch (dpi) to balance legibility and file size. The use of grayscale or color is
discouraged because of file size. After scanning, resampling to a lower resolution
should be avoided.

When creating PDF files containing images, the images should not be downsampled.
Downsampling does not preserve all of the pixels in the original. For PDF images, one
of the following lossless compression techniques should be used:

• For lossless compression of color and grayscale images, use Zip/Flate

(one technique with two names). This is specified in Internet RFC 1950
and RFC 1951 (http://www.ietf.org/rfc/rfc1950.txt).

• For lossless compression of black and white images, use the CCITT Group
4 Fax compression technique. It is specified as CCITT recommendations
T.6 (1988) - Facsimile coding schemes and coding control functions for
Group 4 facsimile apparatus.

Paper documents containing hand-written notes should be scanned at a resolution of at

least 300 dpi.

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Hand-written notes should be done in black ink for clarity. Higher resolution is
specifically requested when scanning documents containing non-Western characters
(e.g. Kanji); 600 dpi is recommended.
For photographs, the image should be obtained with a resolution of 600 dpi. If black
and white photos are submitted, 8-bit grayscale images should be considered. If color
photos are submitted, 24-bit RGB images should be considered. A captured image
should not be subjected to non-uniform scaling (i.e., sizing). Gels and karyotypes
should be scanned directly, rather than from photographs. Scanning should be at 600
dpi and 8-bit grayscale depth. Plotter output graphics should be scanned or captured
digitally at 300 dpi.
High-pressure liquid chromatography or similar images should be scanned at 300 dpi.
Applicants should validate the quality of the renditions.

2.1.6.1 Electronic source documents

To allow functionality such as text searching, copying and pasting into editable formats,
PDF documents should be created (rendered) directly from their electronic source
documents, except where the applicant has no access to the electronic source document.
Such exempted documents are for example:
• copies of documents provided by regulatory authorities such as
manufacturer’s licences, certificates of suitability, manufacturing
authorizations,
• copies of documents from other external sources like certificates of
analysis,
• any literature references sourced from journals, periodicals and books.
If documents are sourced from a scanned original the only way to create searchable text
is using an Optical Character Recognition (OCR) routine. The use of OCR should be
considered when preparing key documents of the submission, in particular the main
body of text of the detailed and critical summaries, or written summaries of the
applicant. Applicants do not have to quality assure the underlying OCR; however, good
quality scanned copies should be used for OCR wherever possible, as more accurate
text will allow for increased utility by reviewers.

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2.1.6.2 Bookmarks and hypertext links

Navigation through an electronic submission is greatly enhanced by the intelligent

use of bookmarks and hypertext links. Documents without TOCs should have
bookmarks included where it aids in the navigation around the document content. For
example, a 5 page document summarizing findings could require bookmarks to aid
navigation. However, a 300 page file containing a single data listing might not require
bookmarks as there is no further internal structure. “Please consult national guidance
documents for further details.”

In general terms, bookmarks and hyperlinks should be used to aid navigation. The
overuse of hyperlinks may confuse rather than help assessors and may cause problems
later in life cycle management. For documents with a table of contents, bookmarks for
each item listed in the table of contents should be provided including all tables, figures,
publications, other references, and appendices. Bookmarks should follow hierarchical
level and order of table of contents. These bookmarks are essential for the efficient
navigation through documents. The bookmark hierarchy should be identical to the table
of contents with no additional bookmark levels beyond those present in the table of
contents

2.1.6.3 Fonts

PDF viewing software automatically substitutes a font to display text if the font used to
create the text is unavailable on the reviewer’s computer. Font substitution can affect a
document’s appearance and structure, and, in some cases, the information conveyed by
a document. GCC Agencies cannot guarantee the availability of any fonts except Times
New Roman, Arial, and Courier and fonts supported in the Acrobat product set itself.
Therefore, all additional fonts used in the PDF files should be embedded to ensure that
those fonts would always be available to the reviewer. When embedding fonts, all
characters for the font should be embedded, not just a subset of the fonts being used in
the document.
Embedding fonts requires additional computer storage space. Three techniques to help
limit the storage space taken by embedding fonts include:
• Limiting the number of fonts used in each document
• Using only True Type or Adobe Type 1 fonts
• Avoiding customized fonts
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2.1.6.4 Page numbering

Only the internal page numbers of the document are expected (1-n). No additional
page/volume numbers running across documents are expected. It is easier to navigate
through an electronic document if the page numbers for the document and the PDF file
are the same. To accomplish this, the first page of the document should be numbered
page 1, and all subsequent pages (including appendices and attachments) should be
numbered consecutively with Arabic numerals. Roman numerals should not be used to
number pages (e.g., title pages, tables of contents) and pages should not be left
unnumbered (e.g., title page). Numbering in this manner keeps the Acrobat numbering
in synchrony with the internal document page numbers.
The only exception should be where a document is split because of its size (Refer to
Section 2.1.5 for information regarding File Size); the second or subsequent file should
be numbered consecutively to that of the first or preceding file.

2.1.6.5 Open Dialog Box

The open dialog box sets the document view when the file is opened. The initial view
of the PDF files should be set as Bookmarks and Page. If there are no bookmarks, the
initial view as Page only should be set. The Magnification and Page Layout should be
set as default.

2.1.6.6 Use of Acrobat Plug-Ins

It is appropriate to use plug-ins to assist in the creation of a submission. However, the

review of the submission should not call for the use of any plug-ins in addition to those
provided with Adobe Acrobat because agencies will not necessarily have access to the
additional plug-in functionality.

2.1.6.7 Hard Media (CD/DVD)

Where electronic files are provided on finalized optical media such as CD or DVD,
each hard medium on which the e-submission is presented should include at a minimum
the following label information:
• Name of the product,
• Type of application,
• Procedure number (if known in advance by the applicant),
• Name of company,
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 • Target species (if necessary to avoid confusion of products),
• Version (including date),
• Indication as to whether multiple media components are used (and if so,
these should be numbered, e.g. 1/2, 2/2),
The information provided, specifically procedure number and version (including date),
should allow at any procedural step a unique identification of the submission, that can
be referred to by involved competent authorities.
This information should preferably be printed directly onto the hard media as hand-
written or self-adhesive labels may compromise the disc or peel-off in time.
Zipped files should not be used when sending CDs or DVDs.
Applicants should provide the electronic submission on the smallest number of media
components possible, e.g. if the Veterinary submission spans several CDs, the provision
of a DVD is recommended.
If more than one media component is needed, the dossier should be split at a logical
point within the granularity such that the integrity of the granularity is maintained.
Where possible, individual dossier parts (Part 1, Part 2 etc.) should be kept together and
not be split over multiple media components.

2.1.7 Correspondence
In addition to the Veterinary application, information may need to be exchanged to
assist the processing or handling of the application. Not all that correspondence should
be included in the electronic submission. This is because the submission exchange is
currently one way only, from applicant to Agency, and not all correspondence is
directly relevant to the application dossier.

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2.2. Technical information
2.2.1. Use of Electronic Signatures
The use of advanced electronic signatures (digital signatures) will be crucial in
achieving pure electronic communication between the pharmaceutical industry and
regulatory agencies, particularly for authentication of electronic submissions and
documents contained therein. Currently however, the use of digital signatures for
electronic submissions within GCC is not fully supported and digital signatures should
therefore not be used (Please refer to each national competent authority for detailed
guidance on this matter). The applicant has the obligation to ensure a proper
certification of the submitted documents. Valid signatures should be available from the
applicant and be presented at the request of the authorities. National Authorities should,
wherever necessary, accept a signed paper cover letter confirming the correctness of
the submitted file(s).
2.2.2. Security issues
The physical security of the submission during transportation is the responsibility of
the applicant. Once received by national authority, security and submission integrity is
the sole responsibility of the national competent authority. No security settings or
password protection for PDF files should be included. The exception to this rule
includes regulatory forms with pre-existing security and literature references that need
to be copyright protected. At a minimum, the receiver should be able to easily open and
view the content.
2.2.3. Virus protection
The applicant is responsible for checking the submission for viruses. Checking should
be performed with an up-to-date virus checker and be confirmed in the cover letter.
2.2.4. Password protection
Submission or file level security is not permitted. If one-time security settings or
password protection of electronic submissions are used this could constitute grounds
for the rejection of the submission.

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2.3. General Architecture of Veterinary submission
2.3.1. Directory / File Structure
The GCC Specification for Veterinary submission provides the directory and file
structure (see Appendix 1).
2.3.2. Granularity
The folder structure (granularity) for an electronic submission is described in Table 2
for Pharmaceutical products, Table 3 for Immunological products and Table 4 for
MRL products should be used where applicable to prepare any electronic submission,
This hierarchical structure of folders within a root folder gives, depending on the type
of submission, up to three levels of granularity.
The complete folder structure is shown in the table below:

Table 2: Folder structure for a pharmaceutical product

root-<mydrug> Submission-specific root folder

(General Table of Contents)
gtoc.pdf
add-info (Additional information)
cc (Country code as per Appendix 3)
p1 Part 1 – Summary of the dossier
Table of contents Part 1
p1-toc.pdf
 1a-admin-info Administrative information
 1b-spc-pl SPC, Labelling and Package Leaflet
 1c-dacs Critical Summaries
 1c1-qual Quality documentation
 1c2-saf-resid Safety and residues documentation
 1c3-effic Efficacy documentation
 1-responses Responses to questions
p2 Part 2 – Quality documentation
Table of contents Part 2
p2-toc.pdf
 2a-qual-quant-partic Qualitative and quantitative particulars of
the constituents
 2b-manuf Description of the manufacturing method
 2c-contr-start-mat Control of starting materials
 2c1-act-sub Active substances
 2c2-excip Excipients
 2c3-cont-clos-sys container-closure systems
 2c4-bio-origin Substances of biological origin
 2d-contr-intermed Control test carried out at intermediate
stages of the production process
 2e-tests-fin-prod Tests on the finished product
 2f-stab Stability tests
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  2f1-act-sub Active substances

 2f2-fin-prod Finished product

 2g-other-info Other information
p3 Part 3 – Safety and residues tests
Table of contents Part 3
p3-toc.pdf
 3a-safc Safety tests
 3a1-ident Precise identification of the product and of
its active substance(s)
 3a2-pharmacol Pharmacology
 3a3-tox Toxicology
 3a4-other Other requirements
 3a5-ura User safety
 3a6-era Environmental risk assessment
 3b-resid Residue tests
 3b1-ident Precise identification of the product
concerned by the application
 3b2-metab-resid Metabolism and residue kinetics
3b3-resid-analyt-met Residue analytical method
p4 Part 4- Pre-clinical and clinical trials
Table of contents Part 4
p4-toc.pdf
 4a-preclin Pre-clinical trials
 4a1-pharmacol Pharmacology
 4a2-resist Development of resistance
 4a3-tas Tolerance in the target animal species
 4b-clin Clinical trials

Table 3: Folder structure for an immunology product

root-<mydrug> Submission-specific root folder

(General Table of Contents)
gtoc.pdf
add-info (Additional information)
cc (Country code as per Appendix 3)
p1 Part 1 – Summary of the dossier
Table of Contents Part 1
p1-toc.pdf
 1a-admin-info Administrative information
 1b-spc-pl SPC, Labelling and Package Leaflet
 1c-dacs Critical Summaries
 1c1-qual Quality documentation
 1c2-saf Safety documentation
 1c3-effic Efficacy documentation
 1-responses Responses to questions
p2 Part 2 – Quality documentation
Table of Contents Part 2
p2-toc.pdf
 2a-qual-quant-partic Qualitative and quantitative particulars of
the constituents
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  2b-manuf Description of the manufacturing method

 2c-prod-contr-start-mat Production and Control of starting

materials
 2c1-start-mat-in-ph Starting materials listed in
pharmacopoeias
 2c2-start-mat-not- Starting materials not listed in
in-ph pharmacopoeias
 2d-contr-manuf Tests during the manufacturing process
 2e-tests-fin-prod Tests on the finished product
 2f-batch-consist Batch-to-batch consistency
 2g-stab Stability tests
 2h-other-info Other information
p3 Part 3 – Safety tests
Table of Contents Part 3
p3-toc.pdf
 3a-gen-requ General requirements
 3b-lab-tests Laboratory tests
 3c-field-stud Field studies
 3d-era Environmental risk assessment
 3e-gmo Assessment required for VMPs containing
or consisting of GMOs
Table of contents Part 3E
p3e-toc.pdf
 3e-annexes Annexes
p4 Part 4- Efficacy tests
Table of Contents Part 4
p4-toc.pdf
 4a-gen-requ General requirements
 4b-lab-trials Laboratory trials
 4c-field-trials Field trials

Table 4: Folder structure for an MRL application

root-<mydrugsubstance> Submission-specific root folder

gtoc.pdf (General Table of Contents)
add-info (Additional information)
p1 (Part 1 – Administrative data and summary
of the dossier)
p1-toc.pdf (Table of Contents Part 1)
1-admin-info-summary (Administrative information and summary
of evaluation proposed by
applicant/requestor)
1-responses (Response to list of questions)
p2 (Part 2 – Safety file)
p2-toc.pdf (Table of Contents Part 2)
2a-dacs-saf (Detailed and Critical Summary (DACS)
for safety)
2b-ident (Precise identification of the substance
concerned by the application)
2c-pharmacol (Pharmacology)
2d-tox (Toxicology)

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 2e-other (Other effects (immunotoxicity,
microbiological properties of residues,
observations in humans)
2f-adi (Acceptable Daily Intake or alternative
limit)
p3 (Part 3 – Residue file)
p3-toc.pdf (Table of Contents Part 3)
3a-dacs-resid (Detailed and Critical Summary (DACS)
for residues)
3b-metab-resid (Metabolism and residue kinetics)
3c-monit-expos (Monitoring and exposure data, if relevant)
3d-resid-analyt-met (Residue analytical method)
p4 (Part 4 – Risk management considerations)
p4-toc.pdf (Table of Contents Part 4)
4a-other-factors (Other legitimate factors)
4b-other-rm (Other relevant risk management
4c-mrls considerations)
4d-extrapolation (Elaboration of MRLs)
(Considerations on possible extrapolation
of MRLs)

2.3.3. File naming convention

The maximum length of the name of a single folder or file is 64 characters including
the extension. Folder or file names should be written in lower case only. All files should
have one and only one file extension. The file extension should be used to indicate the
format of the file.
For Part 1 administrative information file naming, see Appendix 2.

Root folder
The name of the top level folder ("root folder") of each Veterinary folder structure
should allow appropriate identification of the submission, especially in cases where
more than one Veterinary structure is located on a single hard medium.
Each root folder name must start with the letters "root", followed by a specific
identification of the submission which can be defined by the applicant.
A hyphen ("-" character) should be used as separator.
It is recommended to use as specific identification
• the product (invented) name and/or
• the procedure number (if known), especially if more than one procedure is
included on the same CD, and /or
• the submission date or day of procedure, to allow tracking of updates during
the procedure
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Example
root-mydrug
root-wonderpill-H000001-1nov2018

Folder "add-info" (additional information)

The folder structure includes a folder called "add-info" located in the root folder.
Where the applicant still has to fulfil any specific national requirements, related
country-specific documents should be provided in this folder. If so, subfolders should
be included named with the country code of the country (Appendix 2).
Any files submitted voluntarily for information only, like user instructions for the
reviewer, should also be placed in the folder "add-info". Files and subfolders in the
folder "add-info" are not subject to technical validation. In any case applicants should
ensure that previous submissions include sufficient features for navigation like a
hyperlinked table of contents.
Note that except in the case of the above mentioned documents, administrative
information and scientific documentation should not be located in the “add-info” folder,
but in the veterinary folders corresponding to the relevant veterinary dossier chapters.

2.3.4. Adaptation of Folder Structure

Where the structure defined in Table 2 and Table 3 applies, including additional folders
within the structure of the e-submission is not permitted, with the exception of the folder
"add-info" where subfolders could be constructed.
If applicants wish to further separate information within a given folder, this should only
be done by clearer guidance in the Table of Contents (e.g. adding additional headings),
or by using bookmarks within the appropriate documents (e.g. in order to clearer
differentiate between target species, pharmaceutical forms, or lower numbered sections
e.g. in the quality or safety dossier).
If there are empty folders in the submission because no data is provided these should
be deleted as the folder structure should reflect only what actually is submitted.
Corresponding positions in the relevant table of contents (TOC) should also be deleted.
A justification of absence of the folder should be mentioned in the cover letter.
When only little information is presented for a number of folders at the same level of
granularity, it is acceptable to include all the information in a single PDF at the higher
level of the granularity. This should be indicated in the TOC.
22
2.3.5. Tables of contents: Electronic veterinary dossier
The dossier structure in veterinary submissions might vary considerably between
applicants and applications, and any veterinary dossier should therefore include clear
navigation tools to facilitate the assessment. A clear General Table of Contents GTOC
is an essential tool for navigation within an electronic dossier, and examples for TOC
entries are provided below.
However, the examples are for guidance purposes only; thus, alternative TOCs and file
granularity that can ensure a similar and efficient level of navigation are also acceptable.
In case a file granularity is chosen that combines several documents within a single
PDF (e.g. for a complete dossier subchapter), further navigation features (e.g. via
bookmarks) within the PDF file should be used that follow the same rationale as
described for the TOC examples in this guidance.
The TOC examples below provide solutions for:
1. Simple automated TOC builders, using veterinary electronic submission file and
folder names only (grey shaded examples), or
2. TOCs that include additional information either through manual creation /
editing or by using more complex software solutions to automatically generate
TOCs.
Simple TOC builders must only be used where descriptive file names are used
throughout the submission, thereby ensuring easy identification of content and efficient
navigation.
The general principles below apply similarly to both pharmaceutical and
immunological dossiers.

23
The diagrams below illustrate the recommended use of features for navigation.

Navigation to GTOC only

Navigation via GTOC and part-specific TOCs:

Fig 1: Diagram for recommended use of features for navigation.

The GTOC should be named "gtoc.pdf". The files containing the part-specific TOCs
should be named "p1-toc.pdf", "p2-toc.pdf", "p3-toc.pdf" and "p4-toc.pdf".
In case of immunological products, the contents of Part 3E 'Assessment for products
containing or consisting of GMOs' may be covered by a separate TOC for this subpart,
named "p3e-toc.pdf".
The GTOC should be a complete index to the whole dossier either referring directly to
content documents or via the part-specific TOCs, while the TOC for each part of the
dossier should be a complete index for that part of the dossier. Files being present in

24
the folder "add-info" should not be included in the GTOC or TOCs.

Hypertext links in GTOC or TOCs are essential for efficient navigation through any
larger submission. Therefore, all documents in the submission should be referenced in
a GTOC or TOC using a hyperlink. The general TOC should always be hyperlinked to
any part-specific TOCs. Hyperlinks to the documents in each dossier part should be
present either in the GTOC or the part-specific TOCs. Hyperlinks should only be made
to documents within the same veterinary electronic submission and not to external
sources.
Where applicable, the GTOC structure should follow the structure of an application
dossier. It should be a complete index to the whole dossier.
Example of GTOC level
Part 1 Summary of the Dossier
Part 2 Quality/Pharmaceutical Documentation
The blue underlined text illustrates where hyperlinks to individual documents should
appear.
p1-toc.pdf
p2-toc.pdf

Example of TOC level

2f Stability Tests
2f1 Active substance(s)

2f-act-stab 2f1-stability-active-subst.pdf

The granularity of the GTOC should usually be more detailed than the veterinary
electronic submission folder structure to ensure that documents are easy to find.
A descriptive file name for each document should be used to allow easy identification
of its content where more than one document is listed under the TOC lowest sub-
heading.
Example:
1a-admin-info Administrative information

However where it is not possible to use descriptive file names, e.g. taking into account
path length restrictions, the applicant has to add further information to the TOC such as
descriptive titles, document reference numbers, authors, etc.…

Part 1 Administrative information

25
 Annex-5-5.pdf Curriculum Vitae of the Qualified Person for Pharmacovigilance

2.3.6. Folder names

Folder names should be in English and where the Veterinary submission structure
defined in this guidance is applicable follow exactly the conventions given in:
• Table 2 for pharmaceutical products,
• Table 3 for immunological products and ,
• Table 4 for MRL applications
2.3.7. Folder structure for Initial MAA
The folder structure for an electronic submission of an initial application for marketing
authorization is shown in section 2.3.2.
2.3.8. Use of summary reports in MRL dossier
Summary reports (obligatory Detailed and Critical Summaries or DACS) should be
saved into p1, and the textual summaries are optional (see Table 4).
2.3.9. Submission structure for updates during assessment phase
The initial submission and subsequent amendments during the assessment phase should
use different root folder names to allow efficient tracking of submissions, e.g. by
including the submission date or day of procedure.
Though applicants are strongly encouraged to use in subsequent submissions consistent
file naming conventions there is no requirement to exactly preserve file names during
life cycle changes; in fact, logical differences in file names can be helpful during review
when both files are open simultaneously for comparative or other purposes.

2.3.10. Validation updates

As a consequence of the technical or regulatory validation process there may be the
need for updates of the Veterinary submission.
Normally, a corrected version of the full application has to be re-submitted if the
submission is technically invalid.
If there is a need to update the dossier due to the content validation, the applicant should
liaise with the relevant authority in GCC whether these documents could be submitted
as single documents, or sending an updated veterinary submission is required. Single
files should be properly named so it is easily understood what is submitted.

26
2.3.11. Responses to Questions
In response to questions on the initial submission, the applicant submits document(s)
containing the actual text of the responses as well as amendments to the initial dossier.
If the response submission contains more than a single file, the main response
document(s) should be located in the folder "1-responses" in Part 1. Any additional
documents submitted with the responses should be assigned to the relevant folders
“add-info”, as specified in section 2.3.2. The response submission is a stand-alone
submission; it is thus not required to send an update of the initial veterinary submission
consolidated with the responses (i.e. the new submission should include a cover letter,
the responses and the updated document if needed in relevant sections).
Where new or updated documents are required, easy navigation to the new or updated
documents should be ensured.

27
Appendix 1: Example Screenshot

This appendix is included only to demonstrate how the directory structure may
appear for Veterinary submission for Gulf Cooperation Council (GCC).

Part 1: Folder structure for a pharmaceutical product (Administrative

and Product Information, Clinical Summaries, Responses to questions)

Fig 2: Folder structure Part 1 for Pharmaceutical product

28
Pharmaceutical Folder

29
 Fig 3: Folder structure for pharmaceutical application

Immunology Folder

Fig 4: Folder structure for immunology application

30
MRL folder

Fig 5: Folder structure for MRL application

Note: Please contact the agency before to submit a MRL application

31
Appendix 2: Directory/File Structure for Part 1

The directory / file structure is defined in this appendix as a table containing the
following information:

The names of the actual files and directories used should be presented in lower case
in accordance with the specification. The codes “VAR” and “EXT” represent a variable
component of the file name and a representation of a file extension respectively. The
use of upper case for those codes is for illustrative purposes only to show differentiation
between the variable parts and the fixed part of the name.

Please note that “CC” represents the country code and “LL” the language code. It
is added to a directory if a file is specific to a country.

Section Description Folder File name

add-info Additional data add-info|CC

p1 Part 1
1a Administrative Information
p1\1a-admin-info\1a1-
1a1 Cover letter CC-cover-Var.pdf
cover |CC
p1\1a-admin-info\1a2-
1a2 Application Form CC-form-Var.pdf
form\CC
1a3 Pharmacovigilance
p1\1a-admin-info\1a3-
1a31 Pharmacovigilance System pharmacovigilance\1a31- phvigsystem-Var.pdf
phvig-system
p1\1a-admin-info\1a3-
1a32 Risk Management Plan pharmacovigilance\1a32- riskmgtsystem-Var.pdf
riskmgt-system
1a4 Certificates and Documents
p1\1a-admin-info\1a4-
1a41 GMP Certificate gmp-Var.pdf
certificates\1a41-gmp
p1\1a-admin-info\1a4-
1a42 CPP cpp-Var.pdf
certificates\1a42-cpp
p1\1a-admin-info\1a4-
Certificate of analysis – Drug
1a43 certificates\1a43-analysis- drugsubstance-Var.pdf
Substance & Finished Product
substance
p1\1a-admin-info\1a4-
1a44 Certificate of analysis – Excipients certificates\1a44-analysis- excipients-Var.pdf
excipients
p1\1a-admin-info\1a4-
1a45 Certificate of suitability for TSE certificates\1a45- tse-Var.pdf
certificate-tse

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 p1\1a-admin-info\1a4-
1a46 Patent Information certificates\1a46-patent- patent-Var.pdf
information

Section Description Folder File name

p1\1a-admin-info\1a4-
Letter of access or acknowledgment
1a47 certificates\1a47-letter- accessdmf-Var.pdf
to DMF
access-dmf
1a5 Pricing
p1\1a-admin-info\1a5-
1a51 Price list CC-price-Var.pdf
pricing\1a51-price-list\CC
p1\1a-admin-info\1a5-
1a52 Other documents related CC-others-Var.pdf
pricing\1a52-other-doc\CC
1b SPC and Product Literature (Product Information)
Summary of Product Characteristics p1\1b-spc-pl\1b1-spc|CC
1b1 CC-spc-Var.pdf
(SPC)
p1\1b-spc-pl\1b2-
1b2 Package leaflet (PL) CC-leaflet-Var.pdf
leaflet|CC|LL
p1\1b-spc-pl\1b3-
1b3 Labeling CC-label-Var.pdf
labeling\CC\LL
p1\1b-spc-pl\1b4-
1b4 Artwork (Mock-ups) CC-artwork-Var.pdf
artwork\CC
p1\1b-spc-pl\1b5-
1b5 Samples CC-samples-Var.pdf
samples\CC
1c Critical Summaries
1c1 Quality p1\1c-dacs\1c1-qual quality-Var.pdf
1c2 Safety p1\1c-dacs\1c2-saf-resid safety-residue-Var.pdf
1c3 Efficacy p1\1c-dacs\1c3-effic efficacy-Var.pdf
1-responses Response to Questions p1\1-responses\CC CC-responses-Var.pdf

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Appendix 3: List of codes

GCC AGENCIES

Country Code agency Description

Bahrain BH-MOH Ministry of Health
Kuwait KW-MOH Ministry of Health
Oman OM-MOH Ministry of Health
Qatar QA-NHA National Health Authority
Republic of Yemen YE-MOPHP Ministry of Public Health and Population
Saudi Arabia SA-SFDA Saudi Food and Drug Authority
UAE AE-MOH Ministry of Health

DESTINATION

In most cases, the destination code is an ISO-3166-1 code usually called “country
code”.

Country code Destination

AE State of United Arab Emirates
BH Kingdom of Bahrain
KW State of Kuwait
OM Sultanate of Oman
QA State of Qatar
SA Saudi Arabia
YE Republic of Yemen
COMMON GCC countries

Note: Use “common” as country code when the submission applies to all countries.

LANGUAGE

Language Description
ar Arabic (when required)
en English

34