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. 39 Granting the licence
1 The licence is granted if: a. the application is complete; b. the applicant fulfils all relevant conditions at all facilities for the activities applied for. 2 Swissmedic shall suspend the substantive assessment of the application if criminal proceedings are pending against a Responsible Person in accordance with Articles 5, 6, 17, 18, 23 or 26, as a result of which Swissmedic concludes that the conditions for adequate technical supervision are no longer fulfilled. 3 If a Responsible Person is under investigation for infringing the TPA or the Narcotics Act of 3 October 1951 in criminal proceedings, Swissmedic may suspend the corresponding licence. 4 It may demand a standard private extract from the VOSTRA information system of the Register of Criminal Records or an extract from a foreign criminal records register. 5 The applicant is granted a single licence for all activities in the application in accordance with the TPA and this Ordinance.
Para. 3 — SR 812.121 Para. 4 — Amended by Annex 10 No II 24 of the Criminal Records Register Ordinance of 19 Oct. 2022, in force since 23 Jan. 2023 (AS 2022 698).
Art. 40 Content of the licence
The licence specifies the name of the Responsible Person, the licensed activities and the site of the facilities. It may not be transferred to other persons or to other sites.
Art. 41 Amendments
1 Holders of a licence must apply to Swissmedic with the necessary documentation for any amendments to the content of the licence. 2 They must report the essential details of all major changes to facilities, equipment or procedures used in the manufacture, testing or import and export of medicinal products, for wholesale trading or in trading abroad with medicinal products or for brokerage or agency activities in connection with medicinal products and which could influence quality. 3 Swissmedic shall respond to applications under paragraph 1 and make any objections to amendments as in paragraph 2 within a period of 30 days.
Art. 42 Periodic review
1 Fulfilment of all the conditions for retaining the licence is reviewed periodically by inspection. 2 If the conditions are no longer fulfilled or if their fulfilment cannot be examined, specifically because the licensed activities have not been performed for more than twelve months, Swissmedic may revoke the licence either wholly or in part.
Art. 43 Detailed specifications
Swissmedic may specify the terms of the licensing procedure in greater detail.