Therapeutic Products Act (TPA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 82 Federal government
1 The Federal Council and the Agency shall enforce this Act insofar as the Act states that the Confederation is competent to do so. The Agency is the enforcement authority for products specified in Article 2a. The FOPH is responsible for the enforcement of Chapter 4 Section 2a. The Federal Council may delegate certain of the Agency’s or the FOPH’s tasks to other authorities. 2 The Federal Council shall enact the implementing provisions unless this Act states that the Agency is competent to do so, or when it has not allocated the enactment of provisions of a technical nature or of minor importance to the Agency. 3 Insofar as certain delegated acts and implementing acts of the European Commission in the area of medical devices concern technical or administrative details that are regulated on an ongoing basis and generally amended at short notice, the Federal Council may determine that the relevant acts in the version binding for EU member states are also to be applicable in Switzerland.
Para. 1 — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 3 — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 82a International cooperation
1 The federal authorities responsible for the enforcement of this Act shall cooperate with foreign authorities and international organisations. 2 The Federal Council may conclude treaties under international law concerning: a. the exchange of information with foreign authorities or international organisations and Switzerland’s involvement in international information systems to ensure the safety of therapeutic products; b. the disclosure of personal data, including data on health and on administrative or criminal proceedings or sanctions, to foreign authorities or international organisations, insofar as this is necessary for the enforcement of this Act.
Art. 82a — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 83 Cantons
1 The cantons shall carry out the enforcement tasks: a. that are assigned to them by this Act; b. that are not expressly assigned to the Confederation. 2 The cantons shall notify the Agency of their legislation concerning therapeutic products.