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Eudralex Volume 3 GUIDELINE ON REQUIREMENTS FOR VACCINE ANTIGEN MASTER FILE (VAMF) CERTIFICATION

Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
Guideline
Content:
This document is intended to provide guidance to Marketing Authorisation (MA) Applicants and Marketing Authorisation Holders (MAHs) on issues associated with the submission, evaluation and certification of the VAMF by the EMEA. This guidance may be reviewed after experience. The detailed scientific requirements for an application for VAMF certification are described in the ‘Guideline on the Scientific Data Requirements for a Vaccine Antigen Master File’1.

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