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GCC Module 1 Specifications

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date_gregorian=2015-04-11 date_hijri=1436-06-22 document_type=guide entity=format:application/pdf language=en taxonomy_l1=health taxonomy_l2=pharmaceuticals validity=valid validity_confidence=0.6
SFDA
الحييه العامه للغضا والمواد
Saudi Food & Drug Authority
GCC Module 1
Specifications
Version 1.5
قطاع المواد
Drug Sector

SFDA
اللغه العامه للغفا والدواج
Saudi Food & Drug Authority
GCC Module 1 Specifications
Version 1.5
Drug Sector
Saudi Food & Drug Authority
Please visit SFDA's website at http://www.sfda.gov.sa/En/Drug for the latest update
For Inquiries: SDR.Drug@sfda.gov.sa
For Comments or Suggestions: Drug.Comments@sfda.gov.sa
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SFDA
الهييه العامه للغذاء والمواد
Saudi Food & Drug Authority
Drug Sector
Vision & Mission
Vision
To be the leading regional Drug Regulatory Authority for pharmaceuticals and cosmetic products, with professional excellence and services that contribute to the protection and advancement of public health in the Kingdom of Saudi Arabia.
الرؤيه
ان يكون قطاع اللواء راشدا اقليها في الرقابه علي الادويه ومسحضرات التجميل، ويقدم خدماته بهنيه مكيزه تسهم في حمايه
و وتعزيز الصحه في المملكه العربيه السعوديه.
Mission
Protecting public health by ensuring safety, quality, efficacy and accessibility of human, veterinary drugs and biological products, and safety of cosmetics, through administration of a national regulatory system which is consistent with international best practice. Through our mission, we also provide accurate and scientific-based information to the public and healthcare professionals.
الرساله
حمايه الصحه العامه من خلال ضمان امان وجوده وفعاليه وتوفر الادويه البشريه والبيطريه والمنتجات الحيويه وسلامه مواد
التجميل عبر تطبيق نظام وطني للرقابه متوافق مع افضل الممارسات الدوليه وتقدم المعلومات الواييه المبنيه علي اسس علميه
للعامه والمهنيين الصحيين.
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DOCUMENT CONTROL
<table><tr><td>Version</td><td>Date</td><td>Authors</td><td>Comments</td></tr><tr><td>0.1</td><td>07/12/2010</td><td>Regulatory Affairs</td><td>First draft</td></tr><tr><td>0.2</td><td>08/03/2011</td><td>Regulatory Affairs</td><td>Revised draft</td></tr><tr><td>0.3</td><td>12/06/2011</td><td>Regulatory Affairs</td><td>External consultation</td></tr><tr><td>0.4</td><td>03/12/2011</td><td>Regulatory Affairs</td><td>Final revision</td></tr><tr><td>1.0</td><td>17/12/2011</td><td>Regulatory Affairs</td><td>Published</td></tr><tr><td>1.1</td><td>08/05/2012</td><td>Regulatory Affairs</td><td>Revised document</td></tr><tr><td>1.2</td><td>10/11/2012</td><td>Regulatory Affairs</td><td>Minor changes, checksum update</td></tr><tr><td>1.3</td><td>17/08/2015</td><td>Regulatory Affairs</td><td>Add of submission unit concept, Add values in submission type, some minor changes</td></tr><tr><td>1.4</td><td>17/09/2015</td><td>Regulatory Affairs</td><td>Update</td></tr><tr><td>1.5</td><td>4/11/2015</td><td>Regulatory Affairs</td><td>Final version.Remove of Health/Herbal/Vet submission type</td></tr></table>
Note: For most recent update please refer to annex1
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TABLE OF CONTENTS
1 INTRODUCTION....6
1.1. BACKGROUND 6
1.2. SCOPE 6
1.3. TECHNICAL REQUIREMENTS....7
1.4. CHANGE CONTROL 7
1.5. GLOSSARY 8
2 GCC MODULE 1: REGIONAL INFORMATION 10
2.1. GENERAL CONSIDERATIONS.... 10
2.1.1 DOCUMENT GRANULARITY 10
2.1.2 CORRESPONDENCE.... 10
2.1.3 SEQUENCE NUMBERS 10
2.1.4 BOOKMARKS AND HYPERTEXT LINKS 11
2.2. REGIONAL FILE FORMATS.... 11
2.2.1. MODULE 1.... 11
2.2.2. MODULES 2 TO 5.... 12
2.3. HANDLING OF EMPTY OR MISSING ECTD SECTIONS.... 12
2.4. TECHNICAL INFORMATION.... 13
2.4.1. USE OF ELECTRONIC SIGNATURES 13
2.4.2. SECURITY ISSUES 13
2.4.3. VIRUS PROTECTION.... 13
2.4.4. PASSWORD PROTECTION.... 13
2.5. GENERAL ARCHITECTURE OF MODULE 1 13
2.5.1. CHECKSUM.... 14
2.5.2. ENVELOPE.... 14
2.5.3. XML CATALOGUE.... 15
2.5.4. DIRECTORY / FILE STRUCTURE.... 15
2.5.5. FILE NAMING CONVENTION.... 15
2.6. BUSINESS PROTOCOL 16
2.7. CHANGE CONTROL 16
2.8. INSTRUCTIONS FOR EXTENSION SUBMISSIONS.... 17
2.9. REFORMATTING 17
APPENDIX 18
APPENDIX 1: ENVELOPE ELEMENT DESCRIPTION .... 18
APPENDIX 2: DIRECTORY/FILE STRUCTURE FOR GCC MODULE 1 .... 21
APPENDIX 3: COUNTRY SPECIFIC ELEMENTS .... 28
APPENDIX 4: EXAMPLE SCREENSHOT 29
APPENDIX 5: LIST OF CODES.... 30
APPENDIX 6: MODULARIZED DTD FOR GCC MODULE 1 32
GCC Regional DTD 32
GCC Envelope 36
GCC Leaf 38
ANNEX 1: 40
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1 Introduction
This document specifies Module 1 of the electronic Common Technical Document (eCTD) for Gulf Cooperation Council (GCC).
This document should be read together with the ICH eCTD Specification to prepare a valid eCTD submission for GCC. The latest version of the ICH eCTD Specification can be found at: http://estri.ich.org
The ICH M4 Expert Working Group (EWG) has defined the Common Technical Document (CTD). The ICH M2 EWG has defined, in the current document, the specification for the Electronic Common Technical Document (eCTD). The eCTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, life cycle management and archiving of the electronic submission.
The eCTD specification lists the criteria that will make an electronic submission technically valid. The focus of the specification is to provide the ability to transfer the registration application electronically from industry to a regulatory authority. Industry to industry and agency to agency transfer is not addressed.
1.1. Background
The specification for the eCTD is based upon content defined within the CTD issued by the ICH M4 EWG. The CTD describes the organization of modules, sections and documents. The structure and level of detail specified in the CTD have been used as the basis for defining the eCTD structure and content but, where appropriate, additional details have been developed within the eCTD specification. The philosophy of the eCTD is to use open standards. Open standards, including proprietary standards which through their widespread use can be considered de facto standards, are deemed to be appropriate in general.
1.2. Scope
The CTD as defined by the M4 EWG does not cover the full submission that is to be made in a region. It describes only modules 2 to 5, which are common across all regions. The regional Administrative Information and Prescribing Information is
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described in Module 1. The CTD does not describe the content of module 1 because it is regional specific, nor does it describe documents that can be submitted as amendments or variations to the initial application. The value of producing a specification for the creation of an electronic submission based only upon the modules described in the CTD would be limited. Therefore, the M2 EWG has produced a specification for the eCTD that is applicable to all modules of initial registration applications and for other submissions of information throughout the life cycle of the product, such as variations and amendments.
1.3. Technical 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 eCTD and its subsequent amendments/variations
1.4. Change Control
The specification for the eCTD is likely to change with time. Factors that could affect the content of the specification include, but are not limited to:
- Change in the content of the CTD, either through the amendment of information, at the same level of detail, or by provision of more detailed definition of content and structure
- Change to the regional requirements for applications that are outside the scope of the CTD
- Updating standards that are already in use within the eCTD
- Identification of new standards that provide additional value for the creation and/or usage of the eCTD
- Identification of new functional requirements
• Experience of use of the eCTD by all parties
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1.5. Glossary
A brief glossary of terms (for the purpose of this document only) is indicated below:
<table><tr><td>Applicant</td><td>A pharmaceutical company or its agent that is submitting information in support of an application.</td></tr><tr><td>Application</td><td>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.</td></tr><tr><td>CTD</td><td>Common Technical Document</td></tr><tr><td>DTD</td><td>Document Type Definition</td></tr><tr><td>eCTD</td><td>electronic Common Technical DocumentAn eCTD application may comprise a number of sequences.</td></tr><tr><td>EWG</td><td>Expert Working Group; charged with developing a harmonised guideline that meets the objectives in the Concept Paper and Business Plan.</td></tr><tr><td>GCC</td><td>Gulf Cooperation Council</td></tr><tr><td>ICH</td><td>International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use</td></tr><tr><td>JPEG</td><td>Joint Photographic Experts Group</td></tr><tr><td>PDF</td><td>Portable Document Format</td></tr><tr><td>PNG</td><td>Portable Network Graphics</td></tr><tr><td>Procedure</td><td>A registration procedure for the authorization of medicinal products</td></tr><tr><td>Regulatory activity</td><td>A collection of sequences covering the start to the end of a specific business process, e.g. an initial MA application or Type II variation. It is a concept used in some review tools to group together several business related sequences.</td></tr><tr><td>RTF</td><td>Rich Text Format</td></tr><tr><td>Submission</td><td>A single set of information and/or documents supplied by the applicant as a part of, or the complete, Application. In the context of eCTD, this is equivalent to ‘sequence’</td></tr><tr><td>SVG</td><td>Scalable Vector Graphics</td></tr><tr><td>ToC</td><td>Table of Contents</td></tr><tr><td>XML</td><td>eXtensible Markup Language</td></tr><tr><td>XSL</td><td>eXtensible StyleSheet Language</td></tr><tr><td>Reformat</td><td>Intended to support the reformatting of an existing submission application from any format to eCTD</td></tr><tr><td>Extension</td><td>change to a marketing authorization of a medicine such as changes to the active substance, available strengths, pharmaceutical forms or the route of administration.</td></tr><tr><td>ASMF</td><td>Active Substance Master File</td></tr><tr><td>PMF</td><td>Plasma Master File</td></tr><tr><td>PSUSA</td><td>PSUR Single Assessment procedure</td></tr></table>
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<table><tr><td>USR</td><td>Urgent Safety Restriction</td></tr><tr><td>RMP</td><td>Risk Management Plan</td></tr><tr><td>Submission type</td><td>The submission type describes the regulatory activity to which the content will be submitted.</td></tr><tr><td>Submission unit</td><td>The submission unit element of the envelope metadata set describes the content at a lower level (a “sub-activity”) which is submitted in relation to a defined regulatory activity such as the applicant response to validation issues or list of questions or any other additional information</td></tr></table>
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2 GCC Module 1: Regional Information
The ICH Common Technical Document (CTD) specifies that Module 1 should contain region specific administrative and product information. The content and numbering of Module 1 for GCC is specified in the latest version of the Guidance for Submission that can be found at http://www.sfda.gov.sa
It should be noted that for subsequent submissions in the lifecycle of a medicinal product, e.g. for a variation, not all of the above mentioned kind of documents need be included in Module 1. In addition, other items such as the rationale for variations and renewal documentation could also be included in Module 1.
This document describes only the region-specific information that is common to all eCTD submissions in the Gulf Cooperation countries.
2.1. General Considerations
Typically, an eCTD application will cover all dosage forms and strengths of a product with any one invented name.
2.1.1 Document granularity
Submissions are a collection of documents and each document should be provided as a separate file. The detailed structure of the eCTD should conform to the ICH Granularity Document and GCC M1 specifications.
2.1.2 Correspondence
In addition to the eCTD 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 eCTD. This is because the eCTD exchange is currently one way only, from applicant to Agency, and not all correspondence is directly relevant to the application dossier.
2.1.3 Sequence Numbers
Sequence numbers are used to differentiate between different submissions of the same application over the life cycle of the product.
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2.1.4 Bookmarks and hypertext links
Navigation through an electronic submission is greatly enhanced by the intelligent use of bookmarks and hypertext links. ICH guidance states “It is expected that any document that has a Table of Contents (TOC) will have bookmarks (see the eCTD specification for details). Documents without TOCs should have bookmarks included where it aids in the navigation around the document content. For example, a 4 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.
Additional details on creating bookmarks and hypertext links in PDF documents can be found in the ICH eCTD Specification, Appendix 7.
2.2. Regional File Formats
2.2.1. Module 1
The file formats that can be included in Module 1 are given in Table 1. In addition to the common format PDF as defined by the ICH eCTD Specification Document, for other formats see regional guidance for narrative documents to be included in Module 1.
XML is also an acceptable format for the delivery of structured data in Module 1, specifically the application form and product information, as long as the XML is produced to the standard defined in the electronic Application Forms.
Although the use of the file formats defined in Table 1 is strongly recommended, the GCC and applicants could agree on the use of other formats in Module 1, for example, the proprietary format MS Word is for Product Information documents in Module 1.3 (see specific national guidance).
These documents, if requested, should not be referenced in the eCTD backbone, and should always be provided in addition to the PDF versions.
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Table 1: Acceptable file formats for GCC Module 1
<table><tr><td>Document</td><td>File Format</td><td>Remark</td></tr><tr><td>Administrative forms:Application form and its annexesVariation application form incl. background for the variationRenewal form and its annexes</td><td>XML, PDF, RTFPDF, RTF</td><td>Documents should be generated from electronic source documents, any signature may be embedded as graphic file in the PDF text if desired, although this is not necessary as the hard paper copy contains the legally binding signature.</td></tr><tr><td>Product Information:Labeling textPackaging mock-upsReference to SpecimensReadability TestingInformation relating to Orphan Applications</td><td>XML, PDF, RTFXML, PDF, RTFPDF</td><td>If a higher resolution is necessary for the mock-ups, use JPEG, GIF, PNG or SVG on a case-by-case basis.Labeling texts can be submitted in XML format according to the PIM Data Exchange Standard. In that context, images can be transmitted in JPEG, GIF, PNG, TIF, SVG, or MathML.</td></tr><tr><td>Other</td><td>PDF, RTF</td><td>PDF preferably generated from electronic source</td></tr><tr><td>Document Type Definitions and Stylesheets</td><td>DTD, XSL</td><td>These are XML specific file formats and must only be the specified versions of the specific files required for the submission of electronic Application Forms</td></tr></table>
2.2.2. Modules 2 to 5
No additional file formats are defined for Modules 2 to 5 other than those mentioned in the ICH eCTD Specification Document. The GCC and pharmaceutical companies could agree on a case-by-case basis to use formats other than the common formats (e.g. RTF). However, the use of formats other than those specified by the ICH eCTD Specification Document is discouraged.
2.3. Handling of Empty or Missing eCTD Sections
For new applications (including generic applications), detailed statements justifying the absence of data or specific eCTD sections should be provided in the relevant Quality Overall Summary and/or Non-Clinical/Clinical Overviews (Module 2.3, 2.4, 2.5).
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Note that placeholder documents highlighting 'no relevant content' should not be placed in the eCTD structure, as these would create a document lifecycle for non-existent documents, and unnecessary complication and maintenance of the eCTD.
Note: for a generic application, there is no need to provide a justification for content that is typically absent.
2.4. Technical information
2.4.1. 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).
2.4.2. Security issues
The physical security of the submission during transportation is the responsibility of the applicant. Once received by national competent authority, security and submission integrity is the sole responsibility of the national competent authority.
2.4.3. 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.
2.4.4. 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.
2.5. General Architecture of Module 1
The GCC Module 1 architecture is similar to that of modules 2 to 5 of the eCTD, comprising a directory structure and a backbone with leaves. The backbone must be a
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valid XML document according to the GCC Regional Document Type Definition (DTD). The backbone instance (the gc-regional.xml file) contains meta-data for the leaves, including pointers to the files in the directory structure. In addition, the GCC Regional DTD defines meta-data at the submission level in the form of an envelope. The root element is "gc-backbone" and contains two elements: "gc-envelope" and "m1-gc".
The GCC Regional DTD is modularized i.e. the envelope and leaves are referenced from the main part of the DTD as external entities called respectively "gc-envelope.mod" and "gc-leaf.mod". The "gc-leaf" is identical to the leaf element described in the ICH eCTD DTD; reference is made to Table 6-8 of the ICH eCTD Specification. A full description of the GCC Regional DTD can be found in Appendix 4 of this specification.
2.5.1. Checksum
√ GCC Module 1 v1.4 checksum for “gc-regional.dtd” is: 0e089da2bc79ddec16c8496e1644d558
√ GCC Module 1 v1.4 checksum for “gc-envelope.mod” is: d2a8ea399fccf6af13b529f009c6f739
√ GCC Module 1 v1.4 checksum for “gc-leaf.mod” is: f131823f73b74c4c8d16291d02643bec
√ GCC Module 1 v1.4 checksum for “gc-regional.xsl” is: 96aef6e591f7a8337954faddb06f735d
Note: See “checksum.pdf” for complete hash values
2.5.2. Envelope
The "gc-envelope" element is designed to be used for all types of submissions (initial, variations, renewals, etc.) for a given medicinal product and will mainly be used for the first simple processing at the agency level. The envelope provides meta-data at the submission level. A description of each "envelope" element is provided in Appendix 1 of this specification.
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2.5.3. XML Catalogue
The “m1-gc” element of the GCC regional DTD is based on the same conceptual approach as the common part of the ICH eCTD DTD. It provides an XML catalogue with meta-data at the leaf level including pointers to the location of files in a directory structure. As for the ICH eCTD DTD, the “m1-gc” element maps to the directory structure. (There may at times be what is seen to be a 'redundant' directory structure, but this is necessary in order to be able to use the same file/directory structure for all procedures.)
2.5.4. Directory / File Structure
The GCC Module 1 Specification provides the directory and file structure (see Appendix 2).
2.5.5. File Naming Convention
The eCTD file naming conventions described in the ICH M2 eCTD Specification and this document are highly recommended. If an applicant wishes to submit multiple files in one section, where only one highly recommended name is available, this can be achieved using a suffix to the filename,
File names have fixed and variable components. Components are separated by a hyphen. No hyphens or spaces should be used within each component.
Fixed components are mandatory. The variable component is optional and should be used as appropriate to further define these files. The variable component if used should be a meaningful concatenation of words without separation and should be kept as brief and descriptive as possible. File extensions in line with this specification should be applied as applicable.
The first component in a file name must be the country code as per Appendix 5 except when the document is valid for all countries within the particular procedure. The second component must be the document type code. The third component if necessary should be the variable component.
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There are no recommendations for variable components in this specification. The format of the file is indicated by the file extension. File names must always be in lowercase, in line with the ICH eCTD specification.
Examples are:
sa-cover.pdf (Saudi Arabia)
ae-cover.pdf (UAE)
bh-cover.pdf (Bahrain)
kw-cover.pdf (Kuwait)
qa-cover.pdf (Qatar)
ye-cover.pdf (Yemen)
sa-form.pdf (Saudi Arabia)
om-form.pdf (Oman)
2.6. Business protocol
The detailed business process between industry and the GCC will form part of the Industry Guidance for eCTDs. For some period of time the exchange of regulatory information will take place through exchange of physical media such as CD/DVD-Rs:
1. The actual submission of the physical media on which the application is contained should be accompanied by at least a signed, paper copy of the cover letter (the content of this cover letter is defined in the ICH eCTD Specification Document Appendix 5, as is the packaging of the media units)
2. The GCC will acknowledge the proper receipt and result of the validation process (technical [e.g. virus check, XML check, etc.] and content based) to the Sponsor or Agent that submitted the eCTD.
2.7. Change control
The GCC Module 1 specification is likely to change with time. Factors that could affect the content of the specification include, but are not limited to:
- Change in the content of the Module 1 for the CTD, either through the amendment of information, at the same level of detail, or by provision of more detailed definition of content and structure
- Change to the regional requirements for applications that are outside the scope of the CTD
- Update of standards that are already in use within the eCTD
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- Identification of new standards that provide additional value for the creation and/or usage of the eCTD
• Identification of new functional requirements
• Experience of use of the eCTD by all parties, in particular Module 1.
2.8. Instructions for Extension Submissions
Several dosage forms, routes of administration or different strengths can be managed within a single eCTD application, and this helps avoid submission of data multiple times (e.g. active substance changes). Submissions for an extension can either be submitted within an existing eCTD application, as a new sequence (continuous sequence numbering), or as a new eCTD application (sequence 0000), depending on the procedure.
For Extension submission, only new data must be submitted as a new sequence in the already submitted eCTD. The submission type has to be “extension”.
If single eCTDs are used for each strength or form of a product, full data concerning the extension applied for has to be included in the submitted eCTD and therefore clear information should be given to the assessor on what is new compared to earlier submitted data for the product to avoid unnecessary assessment.
2.9. Reformatting
To support the reformatting of an existing submission application from any format to eCTD, i.e. a baseline eCTD submission containing no content change and which will not be subject to review, the submission unit type ‘reformat’ should be used in the envelope. This type will always be used together with the submission type ‘none’.
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APPENDIX
Appendix 1: Envelope Element Description
The “gc-envelope” element is the root element that defines meta-data of the submission. This element may contain several envelope entries.
<table><tr><td>Element</td><td>Attribute</td><td>Description/Instructions</td><td>Example</td><td>Constraint</td><td>Occurrence</td></tr><tr><td>gc-envelope</td><td></td><td>Root element that provides meta-data for the submission. This element may contain several envelopes, which are country specific.</td><td></td><td>Mandatory</td><td>Unique</td></tr><tr><td>envelope</td><td>country</td><td>This element must be country specific (See appendix 5)</td><td>sa</td><td>Mandatory</td><td>Unique</td></tr><tr><td>application</td><td></td><td>This is the number issued for the sponsor and the product by the GCC and remains for the full lifecycle of the product from the first data submission</td><td></td><td>Mandatory</td><td>Unique</td></tr><tr><td>applicant</td><td></td><td>The name of the company submitting the eCTD</td><td>SAFarma</td><td>Mandatory</td><td>Unique</td></tr><tr><td>Agency</td><td>code</td><td>Parent element for the identification of the receiving agency (See appendix 5)</td><td>SA-SFDA</td><td></td><td></td></tr><tr><td>ATC</td><td></td><td>Pick list ATC code</td><td></td><td></td><td>Repeatable</td></tr><tr><td rowspan="2">submission</td><td></td><td>Provides administrative information associated with the submission.</td><td></td><td>Mandatory</td><td>Unique</td></tr><tr><td>type</td><td>See appendix 5</td><td>new-nce</td><td>Mandatory</td><td>Unique</td></tr><tr><td rowspan="2">submission-unit</td><td></td><td>Describes actions within the regulatory activity like initial submission, update, responses to questions, any additional information or consolidation submissions respectively when closing a regulatory activity.</td><td></td><td>Mandatory</td><td>Unique</td></tr><tr><td>type</td><td>See appendix 5</td><td>reformat</td><td>Mandatory</td><td>Unique</td></tr><tr><td>procedure</td><td></td><td>See appendix 5</td><td>national</td><td>Mandatory</td><td>Unique</td></tr><tr><td>invented-name</td><td></td><td>The name of the medicinal product</td><td>Dawa</td><td>Mandatory</td><td>Repeatable</td></tr><tr><td>inn</td><td></td><td>International Non-proprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.</td><td>Allopurinol</td><td>Optional</td><td>Repeatable</td></tr></table>
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<table><tr><td>Element</td><td>Attribute</td><td>Description/Instructions</td><td>Example</td><td>Constraint</td><td>Occurrence</td></tr><tr><td>sequence</td><td></td><td>This is the sequence number of the submission – this should start at 0000 for the initial submission, and then increase incrementally with each subsequent submission related to the same product e.g. 0000, 0001, 0002, 0003 etc.</td><td>0000</td><td>Mandatory</td><td>Unique</td></tr><tr><td>related-sequence</td><td></td><td>This is the sequence number of a previous submission to which this submission relates e.g. the responses to questions to a particular variation.</td><td>0001</td><td>Optional</td><td>Repeatable</td></tr><tr><td>submission-description</td><td></td><td>This element is used to briefly describe the submission</td><td></td><td>Mandatory</td><td>Unique</td></tr><tr><td>number</td><td></td><td>This is any number, used by an agency or the applicant to track the submission, in any procedure, in relation to a particular product.</td><td></td><td>Optional</td><td>Repeatable</td></tr></table>
Example of the use of the Related Sequence:
The related sequence number describes the relationship of additional information to the original submission or subsequent submissions.
An illustration of how the related sequence number is used to describe the relationship of additional information to the original and subsequent submissions follows.
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Example of how the Related Sequence should be used:
<table><tr><td>Sequence</td><td>Submission Description</td><td>Related Sequence</td><td>Comment</td></tr><tr><td>0000</td><td>Application for New Generic application</td><td></td><td>This is a new regulatory submission and so no related sequence is included</td></tr><tr><td>0001</td><td>Responses to Section 31 for New Generic application</td><td>0000</td><td>This is continued activity for the regulatory submission initiated in 0000 and so the related sequence points to the beginning of that submission</td></tr><tr><td>0002</td><td>Updated information for New Generic application</td><td>0000</td><td>This is the completion of the regulatory activity for this submission initiated in 0000 and so the related sequence points to the beginning of that submission</td></tr><tr><td>0003</td><td>Application for EXTENSION OF INDICATION (EOI) for the approved product</td><td></td><td>This is the beginning of a new regulatory submission and so no related sequence is included</td></tr><tr><td>0004</td><td>Responses Section 31 for the change in manufacturing site for the approved product</td><td>0003</td><td>This is continued activity for the regulatory submission initiated in 0003 and so the related sequence points to the beginning of that submission</td></tr><tr><td>0005</td><td>Responses to CLIN Section 31 EOI for the approved product</td><td>0003</td><td>This is continued activity for the regulatory submission initiated in 0003 and so the related sequence points to the beginning of that Submission</td></tr></table>
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Appendix 2: Directory/File Structure for GCC Module 1
The directory / file structure is defined in this appendix as a table containing the following information:
<table><tr><td rowspan="7">Sequential number</td><td></td><td>Each item in the table has a unique sequentially assigned reference number. These reference numbers can change with each version of this appendix.</td></tr><tr><td>Number</td><td>CTD section number</td></tr><tr><td>Title</td><td>CTD title</td></tr><tr><td>Element</td><td>Element name in the GCC Backbone</td></tr><tr><td>File/Directory</td><td>File/Directory name from m1-gc should be relative path from gc-m1 e.g. 12-form/gc/sa-form.pdf This is consistent with ICH standards. The file extension corresponds to the file type; i.e., the “pdf” extension is only illustrative.</td></tr><tr><td>Comment</td><td>Comments</td></tr></table>
The names of the actual files and directories used should be presented in lower case in accordance with the eCTD 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. If the file applied to all GCC countries, “CC” will be “common”.
<table><tr><td rowspan="6">1</td><td>Number</td><td></td></tr><tr><td>Title</td><td>GCC Module 1</td></tr><tr><td>Element</td><td>m1-gc</td></tr><tr><td>Directory</td><td>m1/gc</td></tr><tr><td>Comment</td><td>Top level directory for the GCC Module 1 as per ICH eCTD Specification</td></tr><tr><td>2</td><td>Number</td><td></td></tr><tr><td rowspan="4"></td><td>Title</td><td>GCC Module 1 – DTD version 1.0</td></tr><tr><td>Element</td><td></td></tr><tr><td>File</td><td>m1/gc/gc-regional.xml</td></tr><tr><td>Comment</td><td>The GCC Regional XML instance including the envelope information. Note that the operation attribute for the gc-regional.xml should always be set to ‘new’</td></tr><tr><td>3</td><td>Number</td><td>1.0</td></tr></table>
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<table><tr><td rowspan="5"></td><td>Title</td><td>Cover letter</td></tr><tr><td>Element</td><td>m1-0-cover</td></tr><tr><td>Directory</td><td>m1\gc\10-cover</td></tr><tr><td>Comment</td><td>General place holder for cover letter informationIf there is a special cover letter from specific agency, please add the country and language to the directorym1\gc\10-cover\CC\LL.</td></tr><tr><td></td><td></td></tr><tr><td rowspan="6">4</td><td>Number</td><td></td></tr><tr><td>Title</td><td>Cover letter for SFDA</td></tr><tr><td>Element</td><td>m1-0-cover</td></tr><tr><td>Directory</td><td>m1\gc\10-cover</td></tr><tr><td>File</td><td>CC-cover-VAR.EXT</td></tr><tr><td>Comment</td><td>Example for the cover letter is specific for (SFDA) in Saudi Arabia, the placeholder will be m1\gc\10-cover\sa\sa-cover.pdf</td></tr><tr><td rowspan="5">5</td><td>Number</td><td>1.1</td></tr><tr><td>Title</td><td>Module 1 table of contents</td></tr><tr><td>Element</td><td>m1-1-table-of-contents</td></tr><tr><td>Directory</td><td>0000</td></tr><tr><td>Comment</td><td>The table of contents should include a list of all documents provided in the data submission by module.In eCTD, the xml backbone replaces the table of contents 0000\index.xml</td></tr><tr><td rowspan="6">6</td><td>Number</td><td>1.2</td></tr><tr><td>Title</td><td>Application form</td></tr><tr><td>Element</td><td>m1-2-application-form</td></tr><tr><td>Directory</td><td>m1\gc\12-form</td></tr><tr><td>File</td><td>CC-form-VAR.EXT</td></tr><tr><td>Comment</td><td>General place holder for application form information.</td></tr><tr><td rowspan="5">7</td><td>Number</td><td>1.3</td></tr><tr><td>Title</td><td>Product Information</td></tr><tr><td>Element</td><td>m1-3-product-information</td></tr><tr><td>Directory</td><td>m1\gc\13-pi</td></tr><tr><td>Comment</td><td>General placeholder for Product Information</td></tr><tr><td rowspan="6">8</td><td>Number</td><td>1.3.1</td></tr><tr><td>Title</td><td>Summary of Product Characteristics (SPC)</td></tr><tr><td>Element</td><td>m1-3-1-spc</td></tr><tr><td>Directory</td><td>m1\gc\13-pi\131-spc</td></tr><tr><td>File</td><td>CC-spc-VAR.EXT</td></tr><tr><td>Comment</td><td>General placeholder for SPC.English SPC the directory is m1\gc\13-pi\131-spc\CC/en</td></tr><tr><td rowspan="3">9</td><td>Number</td><td>1.3.2</td></tr><tr><td>Title</td><td>Labeling</td></tr><tr><td>Element</td><td>m1-3-2-label</td></tr></table>
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<table><tr><td rowspan="4"></td><td>Directory</td><td>m1\gc\13-pi\132-labeling</td></tr><tr><td>File</td><td>CC-label-VAR.EXT</td></tr><tr><td>Comment</td><td>General placeholder for labelingThe directory is m1\gc\13-pi\132-labeling\CC\LL</td></tr><tr><td>Number</td><td>1.3.3</td></tr><tr><td rowspan="4">10</td><td>Title</td><td>Patient information leaflet</td></tr><tr><td>Element</td><td>m1-3-3-pil</td></tr><tr><td>Directory</td><td>m1\gc\13-pi\133-leaflet</td></tr><tr><td>Comment</td><td>General placeholder for Patient information leaflet</td></tr><tr><td rowspan="5">11</td><td>Number</td><td>1.3.3.1</td></tr><tr><td>Title</td><td>Arabic Patient information leaflet</td></tr><tr><td>Element</td><td>m1-3-3-pil</td></tr><tr><td>Directory</td><td>m1\gc\13-pi\33-leaflet\CC\ar</td></tr><tr><td>File</td><td>CC-leaflet-VAR.EXT</td></tr><tr><td rowspan="5"></td><td>Comment</td><td>Document in Arabic</td></tr><tr><td>Number</td><td>1.3.3.2</td></tr><tr><td>Title</td><td>English Patient information leaflet</td></tr><tr><td>Element</td><td>m1-3-3-pil</td></tr><tr><td>Directory</td><td>m1\gc\13-pi\133-leaflet\CC\en</td></tr><tr><td rowspan="2"></td><td>Comment</td><td>Document in English</td></tr><tr><td>13</td><td>Number</td></tr><tr><td rowspan="5"></td><td>Title</td><td>Artwork (mock-ups)</td></tr><tr><td>Element</td><td>m1-3-4-mockup</td></tr><tr><td>Directory</td><td>m1\gc\13-pi\134-artwork\CC\LL</td></tr><tr><td>File</td><td>CC-artwork-VAR.EXT</td></tr><tr><td>Comment</td><td>Artwork or Mock-ups</td></tr><tr><td rowspan="6">14</td><td>Number</td><td>1.3.5</td></tr><tr><td>Title</td><td>Samples</td></tr><tr><td>Element</td><td>m1-3-5-samples</td></tr><tr><td>Directory</td><td>m1\gc\13-pi\135-samples\CC\LL</td></tr><tr><td>File</td><td>CC-samples-VAR.EXT</td></tr><tr><td>Comment</td><td>Samples</td></tr><tr><td rowspan="5">15</td><td>Number</td><td>1.4</td></tr><tr><td>Title</td><td>Information on the Experts</td></tr><tr><td>Element</td><td>m1-4-expert</td></tr><tr><td>Directory</td><td>m1\gc\14-expert</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="5">16</td><td>Number</td><td>1.4.1</td></tr><tr><td>Title</td><td>Quality</td></tr><tr><td>Element</td><td>m1-4-1-quality</td></tr><tr><td>Directory</td><td>m1\gc\14-expert\141-quality</td></tr><tr><td>File</td><td>quality-VAR.EXT</td></tr></table>
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<table><tr><td></td><td>Comment</td><td></td></tr><tr><td rowspan="7">17</td><td>Number</td><td>1.4.2</td></tr><tr><td>Title</td><td>Non clinical</td></tr><tr><td>Element</td><td>m1-4-2-non-clinical</td></tr><tr><td>Directory</td><td>m1\gc\14-expert\142-nonclinical</td></tr><tr><td>File</td><td>nonclinical-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td></td><td></td></tr><tr><td rowspan="6">18</td><td>Number</td><td>1.4.3</td></tr><tr><td>Title</td><td>Clinical</td></tr><tr><td>Element</td><td>m1-4-3-clinical</td></tr><tr><td>Directory</td><td>m1\gc\14-expert\143-clinical</td></tr><tr><td>File</td><td>clinical-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="5">19</td><td>Number</td><td>1.5</td></tr><tr><td>Title</td><td>Environmental Risk Assessment</td></tr><tr><td>Element</td><td>m1-5-environrisk</td></tr><tr><td>Directory</td><td>m1\gc\15-environrisk</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">20</td><td>Number</td><td>1.5.1</td></tr><tr><td>Title</td><td>Non-GMO</td></tr><tr><td>Element</td><td>m1-5-1-non-gmo</td></tr><tr><td>Directory</td><td>m1\gc\15-environrisk\151-nongmo</td></tr><tr><td>File</td><td>nongmo-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="5">21</td><td>Number</td><td>1.5.2</td></tr><tr><td>Title</td><td>GMO</td></tr><tr><td>Element</td><td>m1-5-2-gmo</td></tr><tr><td>Directory</td><td>m1\gc\15-environrisk\152-gmo</td></tr><tr><td>File</td><td>gmo-VAR.EXT</td></tr><tr><td></td><td>Comment</td><td></td></tr><tr><td rowspan="5">22</td><td>Number</td><td>1.6</td></tr><tr><td>Title</td><td>Pharmacovigilance</td></tr><tr><td>Element</td><td>m1-6-pharmacovigilance</td></tr><tr><td>Directory</td><td>m1\gc\16-pharmacovigilance</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="5">23</td><td>Number</td><td>1.6.1</td></tr><tr><td>Title</td><td>Pharmacovigilance System</td></tr><tr><td>Element</td><td>m1-6-pharmacovigilance-system</td></tr><tr><td>Directory</td><td>m1\gc\16-pharmacovigilance\161-phvig-system</td></tr><tr><td>File</td><td>phvigsystem-VAR.EXT</td></tr><tr><td rowspan="2"></td><td>Comment</td><td></td></tr><tr><td>Title</td><td>Risk Management Plan</td></tr></table>
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<table><tr><td rowspan="5"></td><td>Element</td><td>m1-6-2-risk-management-system</td></tr><tr><td>Directory</td><td>m1\gc\16-pharmacovigilance\162-riskmgt-system</td></tr><tr><td>File</td><td>riskmgtsystem-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td></td><td></td></tr><tr><td rowspan="5">25</td><td>Number</td><td>1.7</td></tr><tr><td>Title</td><td>Certificates and Documents</td></tr><tr><td>Element</td><td>m1-7-certificates</td></tr><tr><td>Directory</td><td>m1\gc\17-certificates</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">26</td><td>Number</td><td>1.7.1</td></tr><tr><td>Title</td><td>GMP Certificate</td></tr><tr><td>Element</td><td>m1-7-1-gmp</td></tr><tr><td>Directory</td><td>m1\gc\17-certificates\171-gmp</td></tr><tr><td>File</td><td>CC-gmp-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">27</td><td>Number</td><td>1.7.2</td></tr><tr><td>Title</td><td>CPP or Free-sales</td></tr><tr><td>Element</td><td>m1-7-2-cpp</td></tr><tr><td>Directory</td><td>m1\gc\17-certificates\172-cpp</td></tr><tr><td>File</td><td>CC-cpp-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">28</td><td>Number</td><td>1.7.3</td></tr><tr><td>Title</td><td>Certificate of analysis – Drug Substance / Finished Product</td></tr><tr><td>Element</td><td>m1-7-3-analysis-substance</td></tr><tr><td>Directory</td><td>m1\gc\17-certificates\173-analysis-substance</td></tr><tr><td>File</td><td>CC-drugsubstance-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">29</td><td>Number</td><td>1.7.4</td></tr><tr><td>Title</td><td>Certificate of analysis – Excipients</td></tr><tr><td>Element</td><td>m1-7-4-analysis-excipients</td></tr><tr><td>Directory</td><td>m1\gc\17-certificates\174-analysis-excipients</td></tr><tr><td>File</td><td>CC-excipients-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">30</td><td>Number</td><td>1.7.5</td></tr><tr><td>Title</td><td>Alcohol-content declaration</td></tr><tr><td>Element</td><td>m1-7-5-alcohol-content</td></tr><tr><td>Directory</td><td>m1\gc\17-certificates\175-alcohol-content</td></tr><tr><td>File</td><td>CC-alcoholcontent-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="4">31</td><td>Number</td><td>1.7.6</td></tr><tr><td>Title</td><td>Pork-content declaration</td></tr><tr><td>Element</td><td>m1-7-6-pork-content</td></tr><tr><td>File</td><td>CC-porkcontent-VAR.EXT</td></tr></table>
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<table><tr><td></td><td>Directory</td><td>m1\gc\17-certificates\176-pork-content</td></tr><tr><td></td><td>Comment</td><td></td></tr><tr><td rowspan="6">32</td><td>Number</td><td>1.7.7</td></tr><tr><td>Title</td><td>Certificate of suitability for TSE</td></tr><tr><td>Element</td><td>m1-7-7-certificate-tse</td></tr><tr><td>Directory</td><td>m1\gc\17-certificates\177-certificate-tse</td></tr><tr><td>File</td><td>CC-tse-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">33</td><td>Number</td><td>1.7.8</td></tr><tr><td>Title</td><td>The diluents and coloring agents in the product formula</td></tr><tr><td>Element</td><td>m1-7-8-diluent-coloring-agents</td></tr><tr><td>Directory</td><td>m1\gc\17-certificates\178-diluent-coloring-agents</td></tr><tr><td>File</td><td>CC-diluent-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">34</td><td>Number</td><td>1.7.9</td></tr><tr><td>Title</td><td>Patent Information</td></tr><tr><td>Element</td><td>m1-7-9-patent-information</td></tr><tr><td>Directory</td><td>m1\gc\17-certificates\179-patent-information</td></tr><tr><td>File</td><td>CC-patent-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">35</td><td>Number</td><td>1.7.10</td></tr><tr><td>Title</td><td>Letter of access or acknowledgements to DMF</td></tr><tr><td>Element</td><td>m1-7-10-letter-access-dmf</td></tr><tr><td>Directory</td><td>m1\gc\17-certificates\1710-letter-access-dmf</td></tr><tr><td>File</td><td>CC-accessdmf-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="5">36</td><td>Number</td><td>1.8</td></tr><tr><td>Title</td><td>Pricing</td></tr><tr><td>Element</td><td>m1-8-pricing</td></tr><tr><td>Directory</td><td>m1\gc\18-pricing</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">37</td><td>Number</td><td>1.8.1</td></tr><tr><td>Title</td><td>Price list</td></tr><tr><td>Element</td><td>m1-8-1-price-list</td></tr><tr><td>Directory</td><td>m1\gc\18-pricing\181-price-list</td></tr><tr><td>File</td><td>CC-price-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">38</td><td>Number</td><td>1.8.2</td></tr><tr><td>Title</td><td>Other documents related</td></tr><tr><td>Element</td><td>m1-8-2-other-document</td></tr><tr><td>Directory</td><td>m1\gc\18-pricing\182-other-doc</td></tr><tr><td>File</td><td>CC-others-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr></table>
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<table><tr><td rowspan="6">39</td><td>Number</td><td>1.9</td></tr><tr><td>Title</td><td>Responses to questions</td></tr><tr><td>Element</td><td>m1-9-responses</td></tr><tr><td>Directory</td><td>m1\gc\19-responses\CC</td></tr><tr><td>File</td><td>CC-responses-VAR.EXT</td></tr><tr><td>Comment</td><td></td></tr><tr><td rowspan="6">40</td><td>Number</td><td>m1-additional-data</td></tr><tr><td>Title</td><td>Additional data</td></tr><tr><td>Element</td><td>m1-additional-data</td></tr><tr><td>Directory</td><td>m1\gc\additional-data\CC</td></tr><tr><td>File</td><td>CC-additionaldata-VAR.EXT</td></tr><tr><td>Comment</td><td>Any additional data requested should be put on this place such as documents that don’t really fit in any other sections (transfer agreement, declaration of conformity of translation, etc.)</td></tr></table>
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Appendix 3: Country Specific Elements
A number of the elements that represent Module 1 TOC headings possess the child element “specific”, which allows country specificity of content to be explicitly indicated.
Module 1 elements that have “specific” child elements can therefore contain multiple documents, each with content for review by a different country in the Gulf Cooperation countries. These elements are listed below:
<table><tr><td>Element</td><td>Attribute</td><td>Description/Instructions</td><td>Example</td><td>Constraint</td><td>Occurrence</td></tr><tr><td>Specific</td><td></td><td>Parent element for identifying the receiving country for a document or documents.</td><td></td><td>Mandatory</td><td>Repeatable</td></tr><tr><td></td><td>country</td><td>The receiving country for the document (see appendix 5)</td><td>sa</td><td>Mandatory</td><td>Unique</td></tr></table>
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Appendix 4: Example Screenshot
This appendix is included only to demonstrate how the directory structure may appear for Module 1 for Gulf Cooperation Council (GCC).

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Appendix 5: List of codes
GCC Agencies (in alphabetic order)
<table><tr><td>Country</td><td>Code agency</td><td>Description</td></tr><tr><td>Bahrain</td><td>BH-MOH</td><td>Ministry of Health</td></tr><tr><td>Kuwait</td><td>KW-MOH</td><td>Ministry of Health</td></tr><tr><td>Oman</td><td>OM-MOH</td><td>Ministry of Health</td></tr><tr><td>Qatar</td><td>QA-NHA</td><td>National Health Authority</td></tr><tr><td>Republic of Yemen</td><td>YE-MOPHP</td><td>Ministry of Public Health and Population</td></tr><tr><td>Saudi Arabia</td><td>SA-SFDA</td><td>Saudi Food and Drug Authority</td></tr><tr><td>UAE</td><td>AE-MOH</td><td>Ministry of Health</td></tr></table>
Procedure
<table><tr><td>Type</td><td>Description</td></tr><tr><td>gcc</td><td>GCC procedure</td></tr><tr><td>national</td><td>National procedure</td></tr></table>
Submission
<table><tr><td>Type</td><td>Description</td></tr><tr><td>asmf</td><td>Active Substance Master File</td></tr><tr><td>extension</td><td>Extension Submission*</td></tr><tr><td>new-bio</td><td>MAA - Biological</td></tr><tr><td>new-gen</td><td>MAA - Generic (Multisource)</td></tr><tr><td>new-nce</td><td>MAA - New chemical Entity</td></tr><tr><td>new-rad</td><td>MAA - Radiopharmaceuticals</td></tr><tr><td>none</td><td>In the exceptional case of reformatting the application no regulatory activity is allowed. Therefore, ‘none’ must be stated. The submission unit will identify the sub-activity related to the product.</td></tr><tr><td>pmf</td><td>Plasma Master File</td></tr><tr><td>psur</td><td>Periodic Safety Update Report</td></tr><tr><td>psusa</td><td>PSUR single assessment procedure</td></tr><tr><td>renewal</td><td>Renewal of Marketing Authorization</td></tr><tr><td>rmp</td><td>Risk Management Plan</td></tr><tr><td>transfer-ma</td><td>Transfer of Marketing Authorization</td></tr><tr><td>usr</td><td>Urgent Safety Restriction</td></tr><tr><td>var-type1</td><td>Variation Type 1</td></tr><tr><td>var-type2</td><td>Variation Type 2</td></tr><tr><td>withdrawal</td><td>Withdrawal</td></tr></table>
*consult your local regulatory authority before submission
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Submission unit
<table><tr><td>Type</td><td>Description</td></tr><tr><td>additional-info</td><td>Other additional Information (could include, for example, missing files) and should only be used, if response is not suitable</td></tr><tr><td>closing</td><td>Submission unit that provides the final documents in the GCC procedure following the decision of the GCC committee</td></tr><tr><td>correction</td><td>Correction to the published annexes in the GCC procedure (usually shortly after approval)</td></tr><tr><td>initial</td><td>Initial submission to start any regulatory activity</td></tr><tr><td>reformat</td><td>Intended to support the reformatting of an existing submission application from any format to eCTD, i.e. a baseline eCTD submission containing no content change and which will not be subject to review. This type will always be used together with the submission type ‘none’</td></tr><tr><td>response</td><td>Submission unit that contains the response to any kind of question, validation issues out-standing information requested by the agency</td></tr></table>
DESTINATION
In most cases the destination code is an ISO-3166-1 code usually called “country code”.
<table><tr><td>Country code</td><td>Destination</td></tr><tr><td>AE</td><td>State of United Arab Emirates</td></tr><tr><td>BH</td><td>Kingdom of Bahrain</td></tr><tr><td>KW</td><td>State of Kuwait</td></tr><tr><td>OM</td><td>Sultanate of Oman</td></tr><tr><td>QA</td><td>State of Qatar</td></tr><tr><td>SA</td><td>Saudi Arabia</td></tr><tr><td>YE</td><td>Republic of Yemen</td></tr></table>
Note: Use “common” as country code when the submission applies to all countries.
LANGUAGE
<table><tr><td>Language</td><td>Description</td></tr><tr><td>ar</td><td>Arabic (when required)</td></tr><tr><td>en</td><td>English</td></tr></table>
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Appendix 6: Modularized DTD for GCC Module 1
GCC Regional DTD
<!--
PUBLIC "-//GC//DTD eCTD GCBackbone 1.1//EN"
In the eCTD File Organisation: "util/dtd/gc-regional.dtd"
Created : August 2009
minor changes on elements (Oct 2012)
change "ml-7-5-alcohol-free" in "ml-7-5-alcohol-content"
change "ml-7-6-pork-free" in "ml-7-6-pork-content"
samples from "leaf-node" in "specific"
Modified: August 2015
Modification done in the envelope
Add submission unit concept
Add new values in submission
Minor changes : formatting the DTD
Meaning or value of the suffixes:
? : element must appear 0 or 1 time
* : element must appear 0 or more time
+ : element must appear 1 or more times
<none>: element must appear once and only once
-->
<!-- General declarations, external modules
references.... -->
<!ENTITY % countries "(ae|common|bh|kw|om|qa|sa|ye)">
<!ENTITY % languages "(en|ar)">
<!ENTITY % leaf-node "(( leaf | node-extension )*)">
<!ENTITY % envelope-module SYSTEM "gc-envelope.mod" >
%envelope-module;

<!ENTITY % leaf-module SYSTEM "gc-leaf.mod" >
%leaf-module;

<!ELEMENT specific (
 %leaf-node;
)>

<!ATTLIST specific
 country %countries; #REQUIRED
>

<!-- Root element
.....
<!ELEMENT gc:gc-backbone (
 gc-envelope,
 m1-gc
)>

<!ATTLIST gc:gc-backbone
 xmlns:gc CDATA #FIXED "http://sfda.gov.sa"
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xmlns:xlink CDATA #FIXED
"http://www.w3c.org/1999/xlink"
xml:lang CDATA #IMPLIED
dtd-version CDATA #FIXED "1.1"
>
<!-- 
 <-- -->
 <!--ELEMENT m1-gc (
 m1-0-cover,
 m1-2-form?,
 m1-3-pi?,
 m1-4-expert?,
 m1-5-environrisk?,
 m1-6-pharmacovigilance?,
 m1-7-certificates?,
 m1-8-pricing?,
 m1-9-responses?,
 m1-additional-data?
 )>
 <!-- 
 <-- -->
 <!--ELEMENT m1-0-cover (
 specific+
 )>
 <!-- 
 <-- -->
 <!--ELEMENT m1-2-form (
 specific+
 )>
 <!-- 
 <-- -->
 <!--ELEMENT m1-3-pi (
 m1-3-1-spc?,
 m1-3-2-label?,
 m1-3-3-pil?,
 m1-3-4-mockup?,
 m1-3-5-samples?
 )>
 <!--ELEMENT m1-3-1-spc (
 pi-doc+
 )>
 <!--ELEMENT m1-3-2-label (
 pi-doc+
 )>
 <!--ELEMENT m1-3-3-pil (
 pi-doc+
 )>
 <!--ELEMENT m1-3-4-mockup (
 specific+
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<! ELEMENT m1-3-5-samples ( specific+ )>
<!ELEMENT pi-doc ( %leaf-node; )>
<!ATTLIST pi-doc xml:lang %languages; #REQUIRED type (spc|label|pil) #REQUIRED country %countries; #REQUIRED > <!--
<![ELEMENT m1-4-expert ( m1-4-1-quality?, m1-4-2-non-clinical?, m1-4-3-clinical? )>
<![ELEMENT m1-4-1-quality <leaf-node;>
<![ELEMENT m1-4-2-non-clinical <leaf-node;>
<![ELEMENT m1-4-3-clinical <leaf-node;>
<!-- 
<!-- 
<![ELEMENT m1-5-environrisk ( (m1-5-1-non-gmo | m1-5-2-gmo)? ) 
<![ELEMENT m1-5-1-non-gmo %leaf-node;>
<![ELEMENT m1-5-2-gmo %leaf-node;>
<!-- 
<![ELEMENT m1-6-pharmacovigilance ( m1-6-1-pharmacovigilance-system?, m1-6-2-risk-management-system? ) 
<![ELEMENT m1-6-1-pharmacovigilance-system %leaf-node;>
<![ELEMENT m1-6-2-risk-management-system %leaf-node;>
<!-- 
<![ELEMENT m1-7-certificates ( m1-7-1-gmp?, m1-7-2-cpp?, m1-7-3-analysis-substance?, m1-7-4-analysis-excipients?, m1-7-5-alcohol-content?, m1-7-6-pork-content?,
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m1-7-7-certificate-tse?, 
m1-7-8-diluent-coloring-agents?, 
m1-7-9-patent-information?, 
m1-7-10-letter-access-dmf? 
> 
<!ELEMENT m1-7-1-gmp %leaf-node;>
<!ELEMENT m1-7-2-cpp %leaf-node;>
<!ELEMENT m1-7-3-analysis-substance %leaf-node;>
<!ELEMENT m1-7-4-analysis-excipients %leaf-node;>
<!ELEMENT m1-7-5-alcohol-content %leaf-node;>
<!ELEMENT m1-7-6-pork-content %leaf-node;>
<!ELEMENT m1-7-7-certificate-tse %leaf-node;>
<!ELEMENT m1-7-8-diluent-coloring-agents %leaf-node;>
<!ELEMENT m1-7-9-patent-information %leaf-node;>
<!ELEMENT m1-7-10-letter-access-dmf %leaf-node;>

<!-- 
...... 
... -->
<!ELEMENT m1-8-pricing ( m1-8-1-price-list?, m1-8-2-other-document? 
)>
<!ELEMENT m1-8-1-price-list %leaf-node;>
<!ELEMENT m1-8-2-other-document %leaf-node;>
 
<!-- 
...... 
... -->
<!ELEMENT m1-9-responses ( specific ) 
<!-- 
<!-- 
...... 
<!ELEMENT m1-additional-data ( specific ) 
<!-- +++ -->
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GCC Envelope
<!--
In the eCTD File Organisation: "util/dtd/gc-envelope.mod"
Version 1.2
Oct 2015
-->
<!-- 
.... -->
.... -->
<!ELEMENT gc-envelope (
 envelope+
)>
<!ELEMENT envelope (
 application,
 applicant,
 agency,
 atc*,
 submission,
 submission-unit,
 procedure,
 invented-name+,
 inn*,
 sequence,
 related-sequence*,
 submission-description
)>
<!-- 
.... -->
<!ELEMENT application (number*)>
<!ELEMENT applicant (#PCDATA)>
<!ELEMENT agency EMPTY>
<!ELEMENT atc (#PCDATA)>
<!ELEMENT submission EMPTY>
<!ELEMENT submission-unit EMPTY>
<!ELEMENT procedure EMPTY>
<!ELEMENT invented-name (#PCDATA)>
<!ELEMENT inn (#PCDATA)>
<!ELEMENT sequence (#PCDATA)>
<!ELEMENT related-sequence (#PCDATA)>
<!ELEMENT submission-description (#PCDATA)>
<!ELEMENT number (#PCDATA)>
<!-- 
...--> 
<!ATTLIST agency code ( AE-MOH | BH-MOH | KW-MOH
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OM-MOH
QA-NHA
SA-SFDA
YE-MOPHP
#REQUIRED>
<!--
. . . . . -->
<!ATTLIST procedure type (
 gcc
 | national
) #REQUIRED>
<!--
<!ATTLIST submission type (asmf
| extension
| new-gen
| new-bio
| new-rad
| none
| pmf
| psur
| psusa
| renewal
| rmp
| transfer-ma
| usr
| var-type1
| var-type2
| withdrawal
) #REQUIRED>
<!--
<!!ATTLIST submission-unit type (initial response
| additional-info
| closing
| correction
| reformat
) #REQUIRED>
<!--
<!!ENTITY % env-countries "(ae|common|bh|kw|om|qa|sa|ye)">
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<!--
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
<!ATTLIST envelope country %env-countries; #REQUIRED >
<!-- +++ -->
GCC Leaf
<!--
In the eCTD File Organisation: "util/dtd/gc-leaf.mod"
Version 1.0
May 2009
This is based on ich-ectd-3-2.dtd;
If the ich-ectd.dtd is modularized, this one could be replaced.
Hence, one is certain that the common and GCC leaf are the same.
-->
<!--
-->
<!ELEMENT node-extension (title, (leaf | node-extension)+)>
<!ATTLIST node-extension
ID ID #IMPLIED
xml: lang CDATA #IMPLIED
>
<!--
----
-->
<!ENTITY % show-list " (new | replace | embed | other | none)
" >
<!ENTITY % 

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