SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
and major deviations (Article 9 paragraph 1 of the TPA and Articles 11 et seq of the TPA); • compassionate use authorisations of medici- nal products (in a simplified procedure, Arti- cles 14 et seq of the TPA) for a limited period – ie, for life-threatening or debilitating dis- eases – if the medicinal products are compat- ible with the protection of health, their use is expected to have a major therapeutic benefit, and no authorised, alternative 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, debilitat- ing or life-threatening disease where there is a high therapeutic benefit and where the standard treatment is either unavailable or unsatisfactory (Article 7 of the OMP) (see 4.1 Fast Track Registration Routes ); • simplified procedures for certain categories of medicinal products where this is compatible with the quality, safety and efficacy require- ments and where there is no conflict with Swiss interests or international agreements – in particular, for generics (but not for biosimi- lars), orphan drugs, and certain categories of medicinal products authorised and/or used in foreign countries (Articles 14 et seq of the TPA and Articles 12 et seq of the OSMA); and • the authorisation procedure on the basis of a notification – in particular, for certain com- plementary medicines without indications and other medicinal products with a low-risk potential (Article 15 of the TPA). Changes to an authorisation that have no or only minimal consequences for the quality, safety or efficacy of a medicinal product must be com- municated to Swissmedic within 12 months of
their implementation (Article 21 of the OMP). Substantial variations require an additional marketing authorisation procedure. Marketing authorisations are in principle transferable upon approval of a respective application by Swiss- medic. Medical devices do not require an authorisation by a public authority prior to being placed on the Swiss market. Instead, they must bear a respec- tive conformity (MD or CE) marking testifying the conformity of the device with the general safety and performance requirements. The conformity assessment procedure is based on Articles 52 and 54 and Annexes IX-XI of the EU-MDR (Articles 21 et seq of the MedDO and Articles 17 et seq of the IvDO). Depending on the risk qualification of the medical device (see 1.3 Different Categories of Pharmaceuticals and Medical Devices ), the conformity is either to be declared by the manufacturer or by a private body certified to conduct conformity assess- ments. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations In principle, ready-to-use medicinal products may only be placed on the market after they have been authorised (Article 9 paragraph 1 of the TPA). However, there are a number of excep- tions to this general rule. • Medicinal products for which a review of the ordinary approval requirements (safe, effec- tive, and of high quality) is not necessary or useful – eg, formula magistralis, officinalis and hospitalis products or products intended for clinical trials – may be placed on the market before they have been authorised (Article 9 paragraphs 2 et seq of the TPA).
338 CHAMBERS.COM
Powered by FlippingBook