VAMF inspections coordination

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This content applies to human and veterinary medicines.

This page describes the procedure for co-ordinating Vaccine Antigen Master File related inspections of the manufacturing sites proposed in the human and veterinary applications for marketing authorisations and various post authorisation applications submitted to the European Medicines Agency through the centralised procedure.

The Agency has a co-ordinating role for these inspections whilst the responsibility for carrying them out rests with the Competent Authority under whose responsibility the manufacturer falls.

Vaccine Antigen Master File inspections

This procedure (effective 1 March 2005) describes the co-ordinating of pre-approval inspections of vaccine antigen manufacturing site(s) under the Vaccine Antigen Master File (VAMF) certification system. Further information is available under Human Medicines.

Send all queries regarding this content to: gmpinsp@ema.europa.eu.

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