Art. 10 – Application

Art. 10

Application

The sponsor shall submit the application documents specified in Annex 1.⁴⁶

The ethics committee may demand additional information.

The investigator may submit the application in place of the sponsor. In this case, the investigator assumes the obligations of the sponsor as set out in Articles 14 and 15 and the notification and reporting obligations to the competent ethics committee.^⁴⁷

46 Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
47 Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323).

Legal act context: SR 810.306 · CTO-MedD · Ordinance · Ordinance of 1 July 2020 on Clinical Trials with Medical Devices (CTO-MedD)

Structure path: Chapter 2 Approval and Notification Procedures Section 2 Procedures to be performed by the Competent Ethics Committee

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Data status: 2025-05-20

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Art. 10

Application

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