Changes in the Application Form for a Marketing Authorisation

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
Declaration and signature

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

2.5 Manufacturers

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):
In section 2.5.3 only the data of the final manufacturer(s) should be mentioned, not the data of brokers or suppliers.

(2) 2.6.2. List of materials of animal and/or human origin contained or used in the manufacturing process of the medicinal product:
For materials of animal and/or human origin contained or used in the manufacturing process of the medicinal product it is requested to include the number of the Certificate of Suitabiltiy for TSE.

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 some

We would like to stress once more that the

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
USER GUIDE FOR THE APPLICATION FORM, AUGUST 2002

(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)
http://dg3.eudra.org/F2/eudralex/vol-2/B/ctdmay02.pdf

List of Abbreviations

• EMEA: European Agency for the Evaluation of Medicinal Products
• MS: Member State
• SPC: Summary of Product Characteristics
• QOS: Quality Overall Summary

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:

• 6th APIC/CEFIC European Conference on APIs, Regulatory Affairs Conference, Budapest, Hungary, 6-7 November 2003

Author:
Dr Barbara Jentges
CONCEPT HEIDELBERG