Commentaries: Art. 52

A temporary licence to use medicinal products in accordance with Article 9b paragraph 1 TPA may be granted to the sponsor of a clinical trial approved in Switzerland if the sponsor:
1. confirms that the medicinal product is identical to the medicinal product used in at least one clinical trial approved in Switzerland;
2. justifies every deviation from the most recently approved protocol and specifies the conditions under which the medicinal product will be used;
3. justifies the non-inclusion of patients in the clinical trial;
4. states the reasons why use is likely to be of major therapeutic benefit;
5. proves that there is no alternative and equivalent medicinal product authorised in Switzerland;
6. proposes and justifies a period of validity for the licence;
7. states and justifies the treatment centres and the proposed number of patients;
8. submits a draft of the information provided for patients; and
9. has obtained a preliminary opinion on letters b–h from the Ethics Committee which approved the reference trial or, in the case of a multicentre clinical trial, from the lead Ethics Committee.
If the application concerns the use of a medicinal product which has been tested in patients with good results in a clinical trial, it must be used in accordance with the protocol for that clinical trial. The conditions set out in paragraph 1 letters a and d–i must be fulfilled.
This licence also covers the import of the medicinal products concerned, including the individual import of immunological medicinal products, blood and blood products.