Medicinal Products Licensing Ordinance (MPLO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 52 Preconditions
1 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: a. confirms that the medicinal product is identical to the medicinal product used in at least one clinical trial approved in Switzerland; b. justifies every deviation from the most recently approved protocol and specifies the conditions under which the medicinal product will be used; c. justifies the non-inclusion of patients in the clinical trial; d. states the reasons why use is likely to be of major therapeutic benefit; e. proves that there is no alternative and equivalent medicinal product authorised in Switzerland; f. proposes and justifies a period of validity for the licence; g. states and justifies the treatment centres and the proposed number of patients; h. submits a draft of the information provided for patients; and i. has obtained a preliminary opinion on letters b–h from the Ethics Committee
Art. 53 Procedure for granting and extending a licence
1 The application is submitted to Swissmedic with the documents listed in Annex 6. 2 Swissmedic may request additional information. 3 It informs the Ethics Committee about its decision and, where appropriate, any subsequent decisions.
Art. 54 Preconditions
1 The sponsor notifies Swissmedic of all major changes affecting the medicinal product or its usage by analogy with Article 34 paragraph 3 letters a‑c of the Ordinance of 20 September 2013 on Clinical Trials. 2 The sponsor notifies Swissmedic of all adverse reactions and events in accordance with Article 59 TPA. 3 The sponsor sends Swissmedic a safety report once a year.
Para. 1 — SR 810.305 Para. 1 — Amended by No III 2 of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 55 Withdrawal of the licence
1 Swissmedic may withdraw the licence in the interest of protecting patients’ health. 2 The announcement of a final Swissmedic decision rejecting the application for a licence to place the medicinal product on the market leads to withdrawal of the licence. 3 If Swissmedic authorises the marketing of the medicinal product, the temporary licence to use the product ends when the medicinal product is actually supplied. The sponsor informs Swissmedic of the time at which the medicinal product is actually supplied.