Vaccine antigens

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Guidance documents

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Document(s) Language Status First published Last updated Effective Date
Guideline on requirements for Vaccine Antigen Master File (VAMF) certification (English only) adopted 17/03/2005   01/04/2005
Guideline on the scientific data requirements for a vaccine antigen master file (VAMF) (English only) adopted 15/12/2003   01/03/2004
Standard Operating Procedure for Co-ordinating pre-approval inspections in the context of Vaccines Antigen Master File certification (English only) adopted 01/03/2005   01/03/2005

Application form

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Document(s) Language Status First published Last updated Effective Date
Application for an EMEA certificate for a Vaccine Antigen Master File (VAMF) (English only)   06/10/2009    

Coordinators list

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Related links

Fees

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Document(s) Language Status First published Last updated Effective Date
Explanatory note on fees payable to the European Medicines Agency (English only)   02/07/2009 11/10/2010 07/10/2010
Change in the method of payment of fees for centralised procedures (English only) adopted 01/12/2005    

Submission dates

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