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Europe Daily Bulletin No. 13416

25 May 2024
SECTORAL POLICIES / Health
European Commission asks for authorisation of non-compliant generic medicines tested by Synapse Labs to be suspended
Brussels, 24/05/2024 (Agence Europe)

On Friday 24 May, in agreement with the EU Member States and following an opinion from the European Medicines Agency (EMA), the European Commission asked the Member States to suspend the market authorisation of a list of generic medicines tested by the Indian company Synapse Labs, due to insufficient evidence concerning the reliability of the test data.

The decision is based on a scientific assessment carried out by the EMA at the request of the Spanish Medicines Agency. The latter...

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