SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
must be the medical effect or application on the human organism. As regards the distinction between medicinal products and medical devices, the decisive fac- tor is not the material composition of the prod- uct, but whether its intended main effect in or on the human body is caused by pharmacological, immunological or metabolic means (medicinal products) or rather through mechanical, physi- cal or physico-chemical effects (medical devic- es) (Article 4 paragraph 1 lit a and b of the TPA; BVGE C-2093/2006, E 3.5). 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products No specific requirements need to be met for the authorisation of biologic medicinal products (Article 2 paragraph 1 lit d of the Ordinance on the Simplified Marketing Authorisation Proce- dures (OSMA)). However, it is necessary that an equilateral black triangle standing on its apex is included in the package leaflet and informa- tion and is accompanied by the statement that this medicinal product is subject to additional monitoring (Article 14a paragraph 1 lit b of the OMAMP). 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices The authorisation of medicinal products is ini- tially valid for a period of five years and is subject to subsequent renewal upon application (Article 16 paragraph 2 of the TPA and Article 16b para- graph 1 of the TPA). If a medicinal product is not placed on the market within three years of the granting of the authorisation, or if it is no longer actually on the market during a period of three consecutive years after it has been placed on the market, Swissmedic may revoke the authorisa- tion (Article 16a paragraph 1 lit a of the TPA).
Medicinal products must fulfil their authorisa- tion requirements for each production unit dur- ing the entire distribution period, whereby such requirements may only be modified, extended or restricted by a formal amendment procedure. Swissmedic may at any time review the authori- sation, adapt it to changed circumstances, or revoke it (Article 16c of the TPA). Regarding medical devices, the necessary cer- tificates of conformity (see 3.4 Procedure for Obtaining a Marketing Authorisation for Phar- maceuticals and Medical Devices ) are valid for a maximum of five years and are extended follow- ing a re-assessment (Article 26 of the MedDO). If a designated body finds that a manufacturer no longer fulfils the requirements of the MedDO, it must set a deadline for correction and otherwise suspend, revoke or restrict the certificate (Article 27 of the MedDO). 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices An authorisation to place medicinal products on the Swiss market is granted based on a respec- tive application (Article 11 of the TPA) and after a detailed examination by Swissmedic. Appli- cants must hold a manufacturing, import or wholesale licence issued by Swissmedic (see 4. Manufacturing of Pharmaceuticals and Medi- cal Devices ), have a registered address, office or branch office in Switzerland, and must prove that the medicinal product is of high quality, safe and effective (Article 10 of the TPA). Different authorisation procedures apply depending on the characteristics and the appli- cation of the medicinal product, as follows: • ordinary procedures for first authorisations of new active pharmaceutical ingredients (APIs)
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