Switzerland

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The European Commission, European Medicines Agency (EMA), Swiss Federal Department of Home Affairs (FDHA) and the Swiss Agency for Therapeutic Products (Swissmedic) have had confidentiality arrangements in place since 2015, allowing for the exchange of confidential information as part of their regulatory and scientific processes. The European Union (EU) and Switzerland also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.

Confidentiality arrangement

The European Commission, EMA, FDHA and Swissmedic signed a confidentiality arrangement in 2015. It is valid for five years and may be renewed.

The confidential information that EMA and Swissmedic can share includes:

Exchange of letters

MRA on GMP compliance

The EU and Switzerland have signed an MRA on GMP. This allows EU authorities and their Swiss counterparts to:

  • rely on each other's GMP inspections of manufacturers in their respective territories;
  • waive batch testing of products on entry into their territories;
  • share information on inspections and quality defects.

For more information on MRAs and the scope of the EU-Switzerland MRA, see Mutual recognition agreements.

Cooperation on H1N1 pandemic

EMA and Swissmedic first entered into a confidentiality arranegment in 2010, to allow the exchange of non-public information on medicines and vaccines under development against the H1N1 influenza pandemic. The H1N1 medicines and vaccines developed in this period remain authorised in the EU and in Switzerland. EMA and Swissmedic extended this arrangement twice in 2011 and in 2012. 

Exchange of letters

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