The European Medicines Agency (EMA), in agreement with the European Commission, has released an updated question and answer document clarifying a number of issues related to the new categories of variations to the terms of marketing authorizations that were introduced by the agency in August 2013.
The European Medicines Agency (EMA), in agreement with the European Commission, has released an updated question and answer document clarifying a number of issues related to the new categories of variations to the terms of marketing authorizations that were introduced by the agency in August 2013. The Commission guidelines on variations to marketing authorizations of medicinal products were amended in 2013. The revision of the variations guidelines was initiated by the pharmacovigilance legislation.
The following clarifications were made to the Q&A document:
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March 29th 2024In this week’s episode, in recognition of international women’s month, Editor Miranda Schmalfuhs has compiled audio clips from interviews with female KOLs that she's been fortunate enough to speak with over this past month for content across a few of our brands.
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