Switzerland

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There is a confidentiality arrangement in place between the European Medicines Agency (EMA), the European Commission's Directorate General for Health and Food Safety (DG SANTE), the Swiss Agency for Therapeutic Products (Swissmedic) and the Swiss Federal Department of Home Affairs (FDHA) since 10 July 2015.

The agreement covers 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. It is valid for five years and may be renewed.

This will complement ongoing activities in the area of quality and manufacturing under the mutual recognition agreement between the EU and Switzerland, signed in 2002.

The arrangement builds on a previous cooperation of EMA and Swissmedic during the H1N1 influenza pandemic, first put in place in 2010 and extended twice for a year in 2011 and in 2012.

Medicines and vaccines used against the H1N1 virus remain authorised in the European Union and in Switzerland.

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Confidentiality arrangement

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Mutual recognition agreement

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