Art. 1 Purpose
1 This Ordinance regulates:
- a.5
- the requirements for the conduct of clinical trials as defined in Article 3 letter l HRA:
- 1.6
- clinical trials with medicinal products, including combinations under Article 2 paragraph 1 letters f and g of the Medical Devices Ordinance of 1 July 2020 (MedDO)7, or transplant products,
- 2.
- clinical trials with in vitro diagnostic medical devices or products under Article 2a paragraph 2 TPA8,
- 3.
- clinical trials of transplantation,
- 4.
- clinical trials that are not clinical trials under numbers 1 to 3;
- b.
- the authorisation and notification procedures for clinical trials;
- c.
- the duties and responsibilities of research ethics committees (ethics committees), the Swiss Agency for Therapeutic Products (the Agency) and the Federal Office of Public Health (the FOPH) in connection with the authorisation and notification procedures;
- d.
- the registration of clinical trials and public access to the registry.
2 The following apply:
- a.
- for clinical trials with medical devices under the MedDO: the Ordinance of
1 July 20209 on Clinical Trials with Medical Devices; - b.
- for clinical trials of xenotransplantation: the Xenotransplantation Ordinance of 16 March 200710 applies.11
5 Amended by Annex 2 No 2 of the O of 1 July 2020 on Clinical Trials with Medical Devices, in force since 26 May 2021 (AS 2020 3033).
6 Amended by Annex No 2 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
8 Term in accordance with Annex No 2 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). This change has been made throughout the text.
9 SR 812.213.3
10 SR 810.213
11 Amended by Annex 2 No 2 of the O of 1 July 2020 on Clinical Trials with Medical Devices, in force since 26 May 2021 (AS 2020 3033).