EU and Swiss regulators sign confidentiality arrangement
Arrangements will improve oversight of medicines for better protection of public and animal health
The European Medicines Agency (EMA) and the European Commission's Directorate General for Health and Food Safety (DG SANTE) have agreed with the Swiss Agency for Therapeutic Products (Swissmedic) and the Swiss Federal Department of Home Affairs (FDHA) to share non-public information on the safety, quality and efficacy of medicines, already authorised or under review, both in Switzerland and in the European Union (EU) in order to enhance public health protection.
The arrangement supports efforts by European and Swiss regulators to improve the oversight of medicines for human and animal health.
The arrangement builds on a previous cooperation of EMA and Swissmedic during the 2009/2010 H1N1 pandemic and on the Mutual Recognition Agreement signed in 2002. The arrangement has come into effect on 10 July 2015, it is valid for 5 years and may be renewed.
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- Administrative arrangements to exchange non-public information on medicinal products between DG SANTE-European Medicines Agency and Swiss Federal Department of Home Affairs-Swissmedic (22/07/2015)
- Reply to the administrative arrangements to exchange non-public information on medicinal products between DG SANTE-European Medicines Agency and Swiss Federal Department of Home Affairs-Swissmedic (22/07/2015)