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Art. 54 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Mandatory authorisation
Legislator summary
AI generatedClinical trials of therapeutic products require authorisation from the Agency in advance. Exempted from mandatory authorisation are clinical trials involving authorised medicinal products used in accordance with the product information. {note: Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} The Federal Council may: a. for other trials, grant an exemption from mandatory authorisation or specify mandatory notification; b. for clinical trials of veterinary therapeutic products, specify mandatory authorisation or notification; c. {note: Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} make modifications to clinical trials subject to mandatory authorisation. As part of the authorisation procedure, the Agency shall verify: a. in the case of medicinal products, whether they comply with the rules of Good Manufacturing Practice and of medicinal product safety; b. in the case of medical devices, whether: 1. the medical devices meet the requirements specified in Article 45, insofar as compliance with these requirements is not the subject of the clinical trial, 2. the risks associated with a medical device are duly considered in the clinical trial, 3. the information on the medical device is in line with current scientific knowledge and is correctly indicated in the protocol. {note: Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} ... {note: Repealed by No I of the FA of 22 March 2019, with effect from 26 May 2021 ( AS 2020 2961; BBl 2019 1).} The Federal Council shall regulate the authorisation procedure. It may define the required form of the application and stipulate that the submission of applications, correspondence and the publication of decisions must be effected electronically. {note: Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} ... In issuing regulations in accordance with paragraphs 3 and 6, the Federal Council shall have regard to the recognised international regulations.
Art. 54 TPA · Mandatory authorisation
Clinical trials of therapeutic products require authorisation from the Agency in advance.
Exempted from mandatory authorisation are clinical trials involving authorised medicinal products used in accordance with the product information.
The Federal Council may: a. for other trials, grant an exemption from mandatory authorisation or specify mandatory notification; b. for clinical trials of veterinary therapeutic products, specify mandatory authorisation or notification; c. make modifications to clinical trials subject to mandatory authorisation.
As part of the authorisation procedure, the Agency shall verify: a. in the case of medicinal products, whether they comply with the rules of Good Manufacturing Practice and of medicinal product safety; b. in the case of medical devices, whether: 1. the medical devices meet the requirements specified in Article 45, insofar as compliance with these requirements is not the subject of the clinical trial, 2. the risks associated with a medical device are duly considered in the clinical trial, 3. the information on the medical device is in line with current scientific knowledge and is correctly indicated in the protocol.
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The Federal Council shall regulate the authorisation procedure. It may define the required form of the application and stipulate that the submission of applications, correspondence and the publication of decisions must be effected electronically.
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In issuing regulations in accordance with paragraphs 3 and 6, the Federal Council shall have regard to the recognised international regulations.