Transcription of Reflection Paper on Good Manufacturing Practice and …
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Reflection Paper on Good Manufacturing Practice and …
Official address Dome nico Sca rlattilaan 6 1083 HS Amsterdam The Netherlands An agenc y of the European Union Address for visits and deliveries Refer to ma .e Send us a question Go to ma .e u/contact Telephone +31 (0)88 781 6000 E u ro p e an M e d ici ne s Ag e nc y, 2022. Reproduction is authorised provided the source is acknowledged. 10 January 2022 EMA/419571/2021 Human Medicines, Pharmacovigilance and Committees Division Version 2 Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders EMA/INS/3094/2022 Pa ge 2/29 Table of contents 1. Introduction and Purpose .. 3 2. Scope .. 4 3. How this Reflection Paper sets out the various MAH Responsibilities.
are carried out, this Reflection Paper may serve as useful guidance for the competent authorities performing the inspections. 2. Scope The Reflection Paper concerns the responsibilities and activities of MAHs with respect to the European Commission’s Guide to GMP (Parts I, II, and its relevant Annexes) for medicines for human and veterinary use.
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