Changes in the Application Form for a Marketing Authorisation

GMP News No. 310

GMP News
30 April 2003

Changes in the Application Formfor 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 thedossier Part 1A or Module 1: Administrative information – Applicationform, March 2003

The Application Form is to be usedfor an application for a marketing authorisation of medicinal products forhuman use submitted to

  • the EMEA under the centralisedprocedure
  • a Member State (as well as Iceland,Lichtenstein and Norway) under either a national or a mutualrecognition procedure.

Usually, a separate application form for each strength andpharmaceutical form is required. For centralised procedures a combinedapplication form is acceptable.

The Application Form can be used either for applications madewith the CTD format or the current EU format. Since 1 July 2003 theCTD-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 inconsultation with the competent authorities of the MS, the EMEA andinterested parties. Modul 1 is the so-called non-common regional ornational 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 tobe common for all regions. The con-common Module 1 providesadministrative, regional or national information like the applicationform, the proposed summary of products characteristis, the labelling andpackage leaflet, etc.

When completing the application form as part of an application for amarketing authorisation of a medicinal product for human use, the UserGuide for the Application Form, August 2003 with hints how to fill inthe application form can be recommended (please find the web-address ofthat document mentioned below).

Please find the six chapters of the Application Form summarised below.The application form contains administrative information and data,, strength, dosage form of the drug product, name/address of theapplicant, 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 AuthorisationApplications 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 asmentioned 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 bementioned, not the data of brokers or suppliers.

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

We would like to remind you of the fact that starting from 1 July 2003all new applications submitted to the registration authorities have to bein the CTD format. The CTD format will be mandatory for all kinds ofprocedures for marketing authorisation, i.e. for centralised,decentralised or national procedures as well as for all products to beapproved (NCEs, radiological drugs, vaccines, herbal medicinal productsetc.)

As a reminder, here some

backgroundinformation: The Guideline 'CommonTechnical Document' has been developed by the appropriate ICH ExpertWorking Group. It was passed in Step 4 of the ICH process in November 2000for adoption to the regulatory bodies of the European Union, Japan and theUS. Since then it has been necessary to prepare the implementation of theCTD 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 besubmitted in the CTD format. In Europe the CTD was meanwhile integratedwith the Notice to Applicants (NTA). The structure of the dossierin the CTD format is now described in detail in The rules governingmedicinal products in the European Union, Volume 2 Notice to Applicants,Volume 2B Presentation and content of the dossier incorporating the CommonTechnical Document (CTD), May 2002.

We would like to stress once more that the

CTDis just an internationallystandardised format for the dossier for a marketing authorisationthat 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, VOLUME2B - Presentation and content of the dossier-Part 1 Summary of thedossier Part 1A or Module 1: Administrative information Applicationform, Mach 2003

(b) Medicinal Products for Human Use, VOLUME 2B - Presentation andcontent 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 thedossier, incorporating the Common Technical Document (CTD) (May 2002)

List of Abbreviations

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

Dr Barbara Jentges


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