Transcription of Reflection Paper on Good Manufacturing Practice and ...
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Reflection Paper on Good Manufacturing Practice and ...
10 January 2022. EMA/419571/2021. Human Medicines, Pharmacovigilance and Committees Division Version 2. Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 An agency of the European Union European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Introduction and Purpose .. 3. 2. Scope .. 4. 3. How this Reflection Paper sets out the various MAH Responsibilities .. 5. 4. The role of the MAH in Facilitating Compliance with GMP and the Marketing Authorisation (MA).. 5. 5. Areas of the EC Guide to GMP that relate to MAHs.
Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders . ... engaged in manufacturing and related activities (e.g. contract analysis) that are subject to EU GMP requirements. This includes holders of manufacturing and importation authorisations, as …
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