SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Different Categories of Pharmaceuti - cals and Medical Devices . 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies Importation and exportation of medicinal prod- ucts and medical devices are mainly gov- erned by the TPA, the MPLO, the MedDO and the Swiss customs legislation. At the point of entry, the responsibility for the application and enforcement of the respective regulations lies with the Federal Office for Customs and Border 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 compe- tence (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) follow- ing an inspection confirming that the necessary technical and operational conditions have been fulfilled and that an appropriate 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 para- graph 1 lit h of the MedDO and Article 4 par- agraph 1 lit g of the IvDO) are not subject to
licensing requirements in Switzerland. However, if a manufacturer is not established within Swit- zerland, its devices may only be placed on the market if it has appointed an authorised repre- sentative in Switzerland that is responsible for the related formal and safety-related aspects and if the importer is registered with Swiss- medic and is assigned a CHRN (Swiss Single Registration Number) (Article 55 of the MedDO and Article 48 of the IvDO) (see 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices ). 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In principle, only medicinal products that have been granted a marketing authorisation by Swissmedic can be imported into Switzerland (Article 9 of the TPA) and importation is subject to a specific licence (Article 18 paragraph 1 lit a of the TPA). Subject to certain exceptions – in particular, in connection with an official batch release from a foreign control authority belonging to the Official Control Authority Batch Release Network (OCABR) – anyone wishing to import immunological medicinal products or blood and blood products generally requires a special licence for each individual shipment (Article 44 of the MPLO). Under certain circumstances, ready- to-use medicinal products without a marketing authorisation in Switzerland may be imported in small amounts by persons for private use or by HCPs (cf Articles 48 and 49 of the MPLO). While no licence for the import of medical devic- es is required (see 7.2 Importer of Record of Pharmaceuticals and Medical Devices ), medi- cal devices must – prior to their placing on the Swiss market – undergo a conformity assess- ment to ensure that general safety and perfor- mance requirements are met (Articles 6 and 21 et seq of the MedDO and Articles 6 and 21 et
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