PMF inspections coordination

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This content applies to human and veterinary medicines.

This page describes the procedure for co-ordinating Plasma 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.

Plasma Master File inspections

This procedure (effective 15 August 2004) describes the co-ordination of pre-approval inspections of the blood establishments in which collection, testing, processing, storage and distribution is carried out. Further information is available under Human Medicines.

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