Agreements on information exchange

Swissmedic fosters close relationships with foreign authorities and endeavours to develop co-operation in the form of treaties. At the foreground here is the exchange of information within the entire process of authorising medicinal products, market monitoring, and the process of elaborating new regulatory provisions related to therapeutic products.

Article 64 of the Therapeutic Products Act (TPA) regulates the conditions and requirements for the provision of information by Swissmedic within the framework of international mutual administrative assistance and in general for providing information to foreign authorities. Based on this provision, Swissmedic is also authorised to request information from foreign authorities or international organisations. When exchanging data, the national provisions regarding data protection always take precedence for Swissmedic. Based on Article 82a TPA, Swissmedic has concluded information agreements with the authorities shown in the list below.

These international agreements can take the form of legally binding agreements (state treaties) or of declarations of intent that are not legally binding. The agreements or declarations of intent have various titles. They can be called, for example, a Memorandum of Understanding (MoU), a Joint Declaration of Intent (JDI), or a Confidentiality Agreement, Arrangement or Commitment.

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