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
