SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd
5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants The manufacture of medicinal products in Switzerland is subject to a mandatory licence (Article 5 paragraph 1 lit a of the TPA). The same applies to anyone with- drawing blood from humans for the purpose of trans- fusion or the manufacture of therapeutic products or for supply to a third party (Article 34 of the TPA). The licence is issued if Swissmedic has successfully veri- fied during an inspection that the necessary technical and operational conditions have been fulfilled and an appropriate system of quality assurance exists (Arti- cle 6 of the TPA and Articles 3 et seq of the MPLO). The licence is issued for an unlimited period of time, whereby Swissmedic performs periodic inspections and may revoke licences if the requirements are no longer fulfilled. Manufacturers of medical devices are not subject to licensing requirements in Switzerland. However, if a manufacturer is not established within Switzerland, its devices may only be placed on the market if it has appointed an authorised representative in Switzerland who is responsible for the related formal and safety- related aspects and is registered with Swissmedic (Articles 51 and 55 of the MedDO, Articles 44 and 48 of the IvDO, Article 11 of the EU-MDR/EU-IVDR). 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Any person engaged in the wholesale trade of medici- nal products must possess a licence (Article 28 para- graph 1 of the TPA). The licence is issued following an inspection by Swissmedic (Article 28 paragraph 2 of the TPA and Articles 11 et seq of the MPLO). No licences are required for the wholesale (Article 4 paragraph 1 lit i of the MedDO and Article 4 paragraph 1 lit h of the IvDO) of medical devices. Foreign manu- facturers, however, need to appoint an authorised rep-
resentative domiciled in Switzerland (see 5.1 Require- ment for Authorisation for Manufacturing Plants ). 6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Categories of Pharmaceuticals and Medical Devices . 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies Importation and exportation of medicinal products and medical devices are mainly governed by the TPA, the MPLO, the MedDO and the Swiss customs legis- lation. At the point of entry, the responsibility for the application and enforcement of the respective regula- tions lies with the Federal Office for Customs and Bor- der Security (FOCBS). The competent governmental authority for any subsequent market surveillance is Swissmedic. The FOCBS and Swissmedic co-operate closely in their joint areas of competence (cf Article 65 of the MPLO). 7.2 Importer of Record of Pharmaceuticals and Medical Devices Any person that professionally imports medicinal products intended for distribution or dispensing must possess a licence issued by Swissmedic (Article 18 paragraph 1 lit a of the TPA) following an inspection confirming that the necessary technical and opera- tional conditions have been fulfilled and that an appro- priate system of quality assurance exists (Article 19 paragraph 1 of the TPA and Articles 11 et seq of the MPLO). Importers of medical devices (Article 4 paragraph 1 lit h of the MedDO and Article 4 paragraph 1 lit g of the IvDO) are not subject to licensing requirements in Switzerland. However, if a manufacturer is not estab- lished within Switzerland, its devices may only be placed on the market if it has appointed an author- ised representative in Switzerland that is responsible for the related formal and safety-related aspects and if the importer is registered with Swissmedic and is assigned a CHRN (Swiss Single Registration Number)
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