Tag Archive: EMA

Reflecting Again on GMP Requirements for Marketing Authorization Holder

November 27, 2023 || Geraldine Carr-Mulry
 
In July 2021, the European Medicines Agency (EMA) published their reflection paper entitled “Good Manufacturing Practice (GMP ) and the Marketing Authorisation Holder (MAH)”. This paper, updated in January 2022, serves as an important guideline for MAH to understand their GMP responsibilities, especially in cases where they may not be…
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