Stem Cell Research Ordinance (SCRO)
Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325).
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 5 Application
When a licence is sought for stem cell derivation with a view to conducting a research project (Art. 7 StRA), the following documents must be submitted to the Federal Office of Public Health (FOPH) for review: a. complete documentation of the stem cell derivation process, including evidence of the suitability of the laboratory facilities; b. complete documentation for the research project involving embryonic stem cells, as submitted to the competent ethics committee in accordance with Article 17 or with the Human Research Act of 30 September 2011 (HRA); c. the decision of the competent ethics committee concerning the approval of the research project; d. a statement, based on an extract from the register specified in Article 18 StRA, of the reasons why embryonic stem cells available in Switzerland are not suitable for the research project; e. information on the number of surplus embryos expected to be required.
Term in accordance with No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325). This change has been made throughout the text. let. a — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325). let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325). let. b — SR 810.30 let. c — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325).
Art. 6 Review of the application
1 The FOPH shall review whether: a. the documents are complete; b. the licensing conditions specified in the StRA are met. 2 It may request additional documents from the project leader.
Art. 7 Period
1 The FOPH shall reach a decision within 60 days. 2 If the FOPH requests additional documents from the project leader, the period shall begin as soon as the documents have arrived. 3 The FOPH shall notify the project leader of the beginning of the period.
Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325). Para. 3 — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325).