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. 1 Purpose
1 The purpose of this Act is to protect human and animal health and to guarantee that only high quality, safe and effective therapeutic products are placed on the market. 2 It shall furthermore: a. protect the consumers of therapeutic products against fraud; b. help to ensure that the therapeutic products placed on the market are used in accordance with their purpose and in moderation; c. help to ensure that a reliable and well-organised supply of therapeutic products, together with the necessary technical information and advice, is available throughout the country. 3 In the implementation of this Act, in particular in the enactment of the regulations and in the application to an individual case, it must be ensured that: a. the efficiency and independence of the control of therapeutic products is guaranteed in Switzerland; b. favourable conditions exist for research and development in the therapeutic product sector; c. all players competing in the market fulfil the same legal requireme
Art. 2 Scope
1 This Act applies to: a. the handling of medicinal products and medical devices (therapeutic products); b. narcotics as defined in the Narcotics Act of 3 October 1951, insofar as they are used as therapeutic products; c. therapeutic treatments, such as gene therapy, insofar as they directly relate to therapeutic products; the Federal Council may enact provisions specific to this subject. 2 The Federal Council may completely or partially exempt medical devices intended for use on animals or in veterinary diagnostics from the scope of this Act. 3 It may make subject to this Act certain products without an intended medical purpose which are comparable to medical devices in terms of functioning and risks profile.
Para. 1 let. a — Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 1 let. b — SR 812.121 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. 2a Devitalised human tissue or cells
1 For therapeutic products which contain or consist of devitalised human tissues or cells, or derivatives thereof, the Federal Council shall specify requirements for the donation, removal, testing and devitalisation of these tissues or cells. 2 It may make subject to specific requirements of this Act and of the Transplantation Act of 8 October 2004 products which contain or consist of devitalised human tissues or cells, or derivatives thereof, and are not therapeutic products, but function as therapeutic products. In addition, it may also specify requirements for the donation, removal, testing and devitalisation of such tissues or cells, or derivatives thereof. 3 Human tissue or human cells may only be removed or used for the manufacture of products as specified in paragraphs 1 and 2 if consent has been obtained for removal. For this tissue and these cells, neither financial gain nor any other advantage may be offered, granted, demanded or accepted.
Art. 2a — Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 2 — SR 810.21
Art. 3 Due diligence
1 Any person handling therapeutic products must take all measures necessary according to the state of the art to ensure that human or animal health is not endangered. 2 The state of the art in science and technology must be considered for complementary medicines without indications, including the principles of the corresponding therapy approach.
Para. 2 — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 4 Definitions
1 In this Act: Medicinal products means products of chemical or biological origin which are intended or claimed to have a medicinal effect on the human or animal organism, in particular in the diagnosis, prevention or treatment of diseases, injuries and handicaps; blood and blood products are also considered to be medicinal products; abis. Medicinal products with indications means medicinal products with an officially authorised indication in a specific field of application which are intended for use in accordance with the rules of the medical and pharmaceutical sciences; ater. Complementary medicines with indications means medicinal products with an officially authorised indication in a specific field of application which are manufactured according to the manufacturing regulations for complementary therapies such as homeopathy, anthroposophic medicine or traditional Asian medicine and whose field of application is determined according to the principles of the corresponding therapy app
Para. 1 let. abis — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. ater — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. tab — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. tab — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 20