Clinical Trials Ordinance (ClinO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 68 Updating of Annexes
The Federal Department of Home Affairs may update Annexes 1–5 in accordance with international or technical developments. It shall undertake updates which may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
Art. 69 Repeal of other legislation
The following Ordinances shall be repealed: 1. Ordinance of 14 June 1993 on the Waiver of Professional Confidentiality in Medical Research; 2. Ordinance of 17 October 2001 on Clinical Trials of medicinal products, in vitro diagnostic medical devices or combinations under Article 2 letters f–h MedDO; 3. HIV Studies Ordinance of 30 June 1993.
let. 1 — [AS 1993 1983] let. 2 — [AS 2001 3511; 2004 4037 No I 6; 2007 5651 No II 3; 2010 1215 Annex 7, 4043; 2012 2777 Annex 5 No 4] let. 3 — [AS 1993 2294]
Art. 70 Amendment of other legislation
The amendment of other legislation is regulated in Annex 6.
Art. 71 Transitional provisions for clinical trials approved under existing law
1 Clinical trials of therapeutic products and transplant products and trials of transplantation which were approved before 1 January 2014 are considered to be Category C clinical trials. 2 Other approved clinical trials are considered to be Category B clinical trials. 3 On request, the authority which approved the clinical trial before 1 January 2014 may assign the clinical trial to a different category. In this case, the liability, coverage, notification, reporting and documentation requirements are governed by the new law. 4 The responsible ethics committee shall make the decision specified in paragraph 3 according to the simplified procedure specified in Article 6 of the HRA Organisation Ordinance of 20 September 2013. 5 The assessment of substantial modifications is governed by the new law.
Para. 4 — SR 810.308
Art. 72 Transitional provisions to the Amendment of 7 June 2024
1 The time limits specified in Article 23a paragraph 1, Article 38 paragraph 2 third sentence, and Article 65a paragraph 1 second sentence begin, for ongoing clinical trials approved before the Amendment of 7 June 2024 comes into force, when this Amendment comes into force; for clinical trials that have only one of two required approvals prior to this Amendment coming into force, the time limit specified in Article 23 paragraph 1bis and Article 50 paragraph 1bis begins when this Amendment comes into force. 2 For ongoing clinical trials approved before the Amendment of 7 June 2024 comes into force, all the notification, reporting and documentation requirements specified in Chapter 2 Section 5, Chapter 3 Section 4 and Chapter 4 Section 2 can be fulfilled under existing law up to a year after this Amendment comes into force. 3 For clinical trials approved before the Amendment of 7 June 2024 comes into force, the liability, liability coverage and retention requirements are governed by exis
Art. 72 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 73
Repealed by No I of the O of 7 June 2024, with effect from 1 Nov. 2024 (AS 2024 322).
Art. 74 Commencement
This Ordinance comes into force on 1 January 2014.