GMP News No. 310
30 April 2003
Changes in the Application Form for a Marketing Authorisation
With this news, we would like to inform you about changes in the Application Form Administrative Data, Update of the Notice to Applicants Medicinal Products for Human Use Volume 2B Presentation and content of the dossier - Part I Summary of the dossier Part 1A or Module 1: Administrative information Application form, March 2003
The Application Form is to be used for an application for a marketing authorisation of medicinal products for human use submitted to
Usually, a separate application form for each strength and pharmaceutical form is required. For centralised procedures a combined application form is acceptable.
The Application Form can be used either for applications made with the CTD format or the current EU format. Since 1 July 2003 the CTD-format will become mandatory in the EU.
The Application Form is part of Module 1 CTD. The content of Module 1 is defined by the European Commission in consultation with the competent authorities of the MS, the EMEA and interested parties. Modul 1 is the so-called non-common regional or national part. Modules 2 (contains high level summaries, e.g. QOS, Nonclinial Overview/Summary, Clinical Overview/Summary), 3 (Quality), 4 (Nonclinical Study Reports) and 5 (Clinical Study Reports) are intended to be common for all regions. The con-common Module 1 provides administrative, regional or national information like the application form, the proposed summary of products characteristis, the labelling and package leaflet, etc.
When completing the application form as part of an application for a marketing authorisation of a medicinal product for human use, the User Guide for the Application Form, August 2003 with hints how to fill in the application form can be recommended (please find the web-address of that document mentioned below).
Please find the six chapters of the Application Form summarised below. The application form contains administrative information and data, e.g. name, strength, dosage form of the drug product, name/address of the applicant, etc.:
Application Form Table of Contents
1. Type of Application
1.1 This application concerns
1.2 Orphan drug designation
1.3 Referring to Annex II of Regulations (EC) No 541/95 or 542/95, as amended
1.4 According to Directive 2001/83/EC
2. Marketing Authorisation Applications Particulars
2.1 Name(s) and ATC code
2.2 Strength, pharmaceutical form, route of administration, container and pack sizes
2.3 Legal status
2.4 Marketing authorisation holder, Contact persons, Company
2.6 Qualitative and quantitative composition
3. Scientific Advice
4. Paediatric Development Programme
5. Other Marketing Authorisation Applications
6. Appended Documents
The application form is updated in sections 2.5.3 and 2.6.2 as mentioned below:
(1) Section 2.5.3 Manufacturer(s) of the active substance(s):
(2) 2.6.2. List of materials of animal and/or human origin contained or
used in the manufacturing process of the medicinal product:
We would like to remind you of the fact that starting from 1 July 2003 all new applications submitted to the registration authorities have to be in the CTD format. The CTD format will be mandatory for all kinds of procedures for marketing authorisation, i.e. for centralised, decentralised or national procedures as well as for all products to be approved (NCEs, radiological drugs, vaccines, herbal medicinal products etc.)
As a reminder, here somebackground information: The Guideline 'Common Technical Document' has been developed by the appropriate ICH Expert Working Group. It was passed in Step 4 of the ICH process in November 2000 for adoption to the regulatory bodies of the European Union, Japan and the US. Since then it has been necessary to prepare the implementation of the CTD by making the necessary changes to the corresponding laws. In Europe, the transition period for the implementation runs out on 1 July next year, i.e. from this date all dossiers for a marketing authorisation have to be submitted in the CTD format. In Europe the CTD was meanwhile integrated with the Notice to Applicants (NTA). The structure of the dossier in the CTD format is now described in detail in The rules governing medicinal products in the European Union, Volume 2 Notice to Applicants, Volume 2B Presentation and content of the dossier incorporating the Common Technical Document (CTD), May 2002.
We would like to stress once more that theCTD is just an internationally standardised format for the dossier for a marketing authorisation that does neither describe its contents nor its extent.
Please find the web-addresses of the referenced documents listed below:
(a) Notice to Applicants Medicinal Products for Human Use, VOLUME
2B - Presentation and content of the dossier-Part 1 Summary of the
dossier Part 1A or Module 1: Administrative information Application
form, Mach 2003
(b) Medicinal Products for Human Use, VOLUME 2B - Presentation and
content of the dossier-Part 1 Summary of the dossier Part 1A or Module 1:
Administrative information - Application form
(c) The rules governing medicinal products in the European Union,
Volume 2 Notice to Applicants, Volume 2B Presentation and content of the
dossier, incorporating the Common Technical Document (CTD) (May 2002)
List of Abbreviations
If you want to get informed about any news regarding regulatory affairs in general and the CTD in detail, please find our European conferences and education courses that cover these topics listed below: