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 .. 5 4. The role of the MAH in Facilitating Compliance with GMP and the Marketing Authorisation (MA).

engage. For example, current EU GDP guidelines in relation to medicinal products for human use require that medicines wholesalers notify the MAH of certain information, e.g. information concerning falsified products and quality defects (Ref. EU GDP Guidelines, 2013, Sections 6.2 and 6.4). As a result, it is

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  Guidelines, Manufacturing, Paper, Medicine, Reflections, Reflection paper

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