Vaccine Antigen Master File (VAMF) dossier requirements

  • Email
  • Help

Type of application and number of copies

  • Applications for initial certification should be submitted according to the VAMF coordinators’ dossier requirements described in the table below.
  • Applications for post-approval procedures e.g. submission of variations to the VAMF certificate, should be submitted to the relevant parties as follows:
    • Type 1A variations - European Medicines Agency only
    • Type 1B variations - European Medicines Agency and primary coordinator who was appointed for the application for initial certification
    • Type II variations, Follow up Measures and Annex II applications - As per initial certification
Memberstate
Member Dossier Requirements
If not appointed coordinators
If appointed coordinators
Paper*
CD Rom**
Paper*
CD Rom**
AUSTRIA
1
1
1
1
BELGIUM
1
1
1
1
CYPRUS
1
1
1
1
CZECH REPUBLIC
1
1
1
1
DENMARK
1
1
1
1
ESTONIA
1
1
1
1
FINLAND
1
1
1
1
FRANCE
1
1
2
1
GERMANY
1
1
4
1
GREECE
1
1
1
1
HUNGARY
1
1
1
1
ICELAND
1
1
1
1
IRELAND
1
1
1
1
ITALY
1
1
2
1
LATVIA
1
1
1
1
LITHUANIA
1
1
1
1
LUXEMBOURG
1
1
1
1
MALTA
1
1
1
1
THE NETHERLANDS
1
1
1
1
NORWAY
1
1
1
1
POLAND
1
1
1
1
PORTUGAL
1
1
2
1
SLOVAK REPUBLIC
1
1
1
1
SLOVENIA
1
1
1
1
SPAIN
1
1
2
1
SWEDEN
1
1
1
1
UNITED KINGDOM
1
1
2
1
EMA
2
1
2
1

* Cover letter, application form with annex (tables of lists of products). If not appointed coordinators, the VAMF dossier will be only be submitted upon request of Member States. The full VAMF dossier in paper version should always be submitted to the European Medicines Agency as requested above.
** Cover letter, application form with annex (tables of lists of products: tables also to be submitted in word version), full VAMF dossier.

Note to the Applicants: The principles outlined above for initial submissions should be applied also to submissions to Lists of Questions i.e. the CD Rom should include the full responses. Any changes to the Tables of lists of products should also be re-submitted (in paper and electronically in word).

How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more