SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd
tion of a product) circumstances of the individual case – must be the medical effect or application on the human organism. As regards the distinction between medicinal prod- ucts and medical devices, the decisive factor is not the material composition of the product, but whether its intended main effect in or on the human body is caused by pharmacological, immunological or meta- bolic means (medicinal products) or rather through mechanical, physical or physico-chemical effects (medical devices) (Article 4 paragraph 1 lit a and b of the TPA; BVGE C-2093/2006, E 3.5). 3.2 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 Simpli- fied Marketing Authorisation Procedures (OSMA)). However, it is necessary that an equilateral black tri- angle standing on its apex is included in the pack- age leaflet and information 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 of Marketing Authorisations The authorisation of medicinal products is initially 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 paragraph 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 authorisation (Article 16a paragraph 1 lit a of the TPA). Medicinal products must fulfil their authorisation requirements for each production unit during the entire distribution period, whereby such requirements may only be mod- ified, extended or restricted by a formal amendment procedure. Swissmedic may at any time review the authorisation, adapt it to changed circumstances, or revoke it (Article 16c of the TPA).
Regarding medical devices, the necessary certificates of conformity (see 3.4 Procedure for Obtaining a Mar- keting Authorisation ) are valid for a maximum of five years and are extended following 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 certifi- cate (Article 27 of the MedDO). 3.4 Procedure for Obtaining a Marketing Authorisation An authorisation to place medicinal products on the Swiss market is granted based on a respective application (Article 11 of the TPA) and after a detailed examination by Swissmedic. Applicants must hold a manufacturing, import or wholesale licence issued by Swissmedic (see 5. Manufacturing of Pharmaceuti- cals and Medical 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 depend- ing on the characteristics and the application of the medicinal product, as follows: • ordinary procedures for first authorisations of new active pharmaceutical ingredients (APIs) and major deviations (Article 9 paragraph 1 of the TPA and Articles 11 et seq of the TPA); • compassionate use authorisations of medicinal products (in a simplified procedure, Articles 14 et seq of the TPA) for a limited period – ie, for life- threatening or debilitating diseases – if the medici- nal products are compatible with the protection of health, their use is expected to have a major therapeutic benefit, and no authorised, alterna- tive or equivalent medicinal product is available in Switzerland (Article 9a of the TPA and Articles 18 et seq of the OSMA); • fast track procedures for first authorisations of new APIs and major deviations on request, available for promising therapies for the prevention or treatment of a severe, debilitating or life-threatening disease where there is a high therapeutic benefit and where the standard treatment is either unavailable or
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