EU Module 1 eCTD Specification - Europa

EU Module 1 eCTD Specification

Version 3.0

October 2015

Annexes

Document Control

Change Record

Version 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 0.91 0.92 0.93 0.95.1 0.95.2 0.95.3 1.0 1.1 1.2 1.2.1 1.3

Date July, 2001 September, 2001 October, 2001 November, 2001 February, 2002 February, 2002 March, 2002 October, 2002 November, 2002 February, 2003 July, 2003 February 2004 May 2004 28 May 2004 23 June 2004 July 2004 December 2005 May 2006 October 2006 May 2008

1.4

August 2009

1.4.1 1.4.2

November 2011 December 2012

2.01

December 2012

Author(s) Stan van Belkum Stan van Belkum Stan van Belkum Stan van Belkum Stan van Belkum Stan van Belkum Stan van Belkum Stan van Belkum Stan van Belkum Stan van Belkum Stan van Belkum M. Bley EMEA EMEA EMEA EMEA EMEA EMEA EMEA EMEA

EMEA

EMA EMA

EFPIA

2.02

February 2013

EFPIA

2.0

February 2013

EFPIA/EMA/NCA

3.0

October 2015

HHMG

Comments Draft Draft Draft Draft Draft Draft Draft Draft Draft Draft Draft Draft Draft Draft Draft Final Integration of PIM Structural changes from CTD Alignment to CTD and Change Requests Incorporation of paediatric requirements and Change Requests Alignment to the New Variation Regulation and Change Requests Alignment to EU M1 v 1.4.1

Updated the xml examples contained in the grey areas.

Updated text and folder structure graphic, changed EMEA to EMA except for the CP procedure number, updated agencies names, Corrected example on folder structure for MRP Changed DTD version in XML examples from 1.4 to 2.0 Added that for CP tracking number is available in Eligibility Confirmation Letter Final Updated the xml examples contained in the grey areas.

Reviewers

Version 0.1-0.3 0.4 0.5-0.6 0.7-0.8 0.9 0.91 0.92 0.95.1

0.95.2

0.95.3

1.1 1.2 1.2.1 1.3

Name EU Regulators Interested parties EU Regulators Interested parties EU regulators EU Regulators ICH, EMEA EU regulators EU Regulators, interested parties

Organisation EU Regulatory Authorities, EMEA

EU Regulatory Authorities, EMEA

EU Regulatory Authorities, EMEA EU Regulatory Authorities, EMEA EU Regulatory Authorities (members TIGes and NtA) EU Regulatory Authorities (members TIGes and NtA), EFPIA, Pharma, other interested parties

EU Regulators, interested parties EU Regulators, interested parties

EU Regulatory Authorities (members TIGes and NtA), EFPIA, Pharma, other interested parties EU Regulatory Authorities (members TIGes and NtA), EFPIA, Pharma, other interested parties

EU Regulators, interested parties EU Regulatory Authorities (members TIGes and NtA), EFPIA,

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1.4 1.4.1 2.0 3.0

EU Regulators, interested parties EU Regulators, interested parties EU Regulators, interested parties EU Regulators, interested parties

Pharma, other interested parties EU Regulatory Authorities (members TIGes and NtA), EFPIA, EGA, other interested parties EU Regulatory Authorities (members TIGes and NtA), EFPIA, EGA, other interested parties EU Regulatory Authorities (members TIGes and NtA), EFPIA, EGA, other interested parties Human Harmonisation Maintenance Group

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TABLE OF CONTENT DOCUMENT CONTROL......................................................................................................................... 2

CHANGE RECORD ................................................................................................................................................ 2 REVIEWERS ......................................................................................................................................................... 2 ANNEX 1: DIRECTORY STRUCTURE EXAMPLES ............................................................................. 5 ANNEX 2: CREATING THE XML EU REGIONAL SUBMISSION......................................................... 9 INSTRUCTIONS FOR A SIMPLE NEW SUBMISSION ............................................................................................... 10 INSTRUCTIONS FOR SUBMISSION OF SUPPLEMENTAL INFORMATION ................................................................. 11 INSTRUCTIONS FOR MRP AND DCP SUBMISSIONS ............................................................................................ 12 ANNEX 3: ENVELOPES FOR DIFFERENT SUBMISSION MODES (VARIATIONS / EXTENSIONS) .............................................................................................................................................................. 14 SINGLE VARIATION ........................................................................................................................................... 14 GROUPING OF VARIATIONS OF THE SAME TYPE, FOR A SINGLE MA .................................................................. 14 GROUPING OF VARIATIONS OF DIFFERENT TYPES, FOR A SINGLE MA............................................................... 15 GROUPING OF TYPE IA VARIATION(S), FOR MULTIPLE MAS ............................................................................. 15 WORKSHARING ? TYPE IB AND/OR TYPE II VARIATIONS, FOR MULTIPLE MAS................................................. 16 ANNEX 4: USAGE OF RELATED SEQUENCES................................................................................ 18

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Annex 1: Directory Structure Examples

This annex is included to demonstrate how the directory structure may appear when applied to each procedure. MRP Directory Structure

This example displays general use of the folder structure for several sections. This example is provided with the following options:

? France as RMS, ? Spain as CMS, ? Submission of PI in PDF - note that this is the initial submission of the basic text in English ? generic, hybrid or bio-similar application

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Centralised Procedure Directory Structure For the Centralised Procedure, most documents will be in English and valid for all European countries. Files should be placed in the country directories inside the `ema' or `common' directory (for instance cf. directory "10-cover"). This example displays general use of the folder structure for all sections, with use of `ema' for the country directory. Note: the Additional Data section should not be used in a Centralised Procedure submission, with the exception of justifications for a new active substance status.

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Decentralised Procedure Directory Structure For the Decentralised Procedure during the mutual phases, most documents will be in English and valid for all European countries. As a result, most files should be placed in the common folder. No country or language folder should be added. However, some exceptions may remain during the mutual phase, such as the submission of country specific additional requirements. This example displays general use of the folder structure for several sections.

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National Procedure Directory Structure

This structure also allows files to be managed by language for a National Procedure.

This example displays general use of the folder structure for several sections.

This example is provided with the following options: ? Belgium as the country for the submission ? Product Information documents provided in all

three official languages of Belgium

General Notes: Section 1.3.3 `Specimen' should contain files listing all of the physical specimens that are included with the submission, as the specimens are physical entities that cannot be submitted electronically. Section 1.3.4 for all procedures has country sub-directories, as consultation is country-specific. The complete structure of folders and files can be consulted in the eCTD Validation Criteria document at It is also available a Harmonised Technical Guidance for eCTD Submissions in the EU that shows how to submit information using the eCTD format at

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