SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd
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 requirements and where there is no conflict with Swiss interests or international agreements – in particular, for gener- ics (but not for biosimilars), 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 noti- fication – in particular, for certain complementary 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 mini- mal consequences for the quality, safety or efficacy of a medicinal product must be communicated to Swissmedic within 12 months of their implementation (Article 21 of the OMP). Substantial variations require an additional marketing authorisation procedure. Mar- keting authorisations are in principle transferable upon approval of a respective application by Swissmedic. Medical devices do not require an authorisation by a public authority prior to being placed on the Swiss market. Instead, they must bear a respective conform- ity (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 Categories of Pharmaceuti- cals and Medical Devices ), the conformity is either to be declared by the manufacturer or by a private body certified to conduct conformity assessments. 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 author-
ised (Article 9 paragraph 1 of the TPA). However, there are a number of exceptions to this general rule. • Medicinal products for which a review of the ordinary approval requirements (safe, effective, and of high quality) is not necessary or useful – eg, formula magistralis, officinalis and hospitalis prod- ucts 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). • Orphan use – the use of medicinal products for the treatment of diseases that are so rare that there is hardly any incentive for a regular marketing author- isation that may be approved in Switzerland for a limited period in a simplified approval procedure is permissible (Article 9a of the TPA and Article 14 paragraph 1 lit f TPA). • Temporary authorisation for use outside of clini- cal trials – Swissmedic may temporarily authorise the use of as yet unauthorised medicinal products intended for clinical trials outside the scope of a clinical trial (Article 9b paragraph 1 of the TPA and Articles 52 et seq of the MPLO). • Temporary authorisation to bridge temporary unavailability – medicinal products may be tempo- rarily or quantitatively authorised by Swissmedic to bridge the unavailability of an identical medici- nal product in Switzerland, provided that they are authorised in another country with an equivalent medicinal product control and no essentially identi- cal medicinal product is authorised and available in Switzerland (Article 9b paragraph 2 of the TPA). • Off-label use (eg, the use of a (properly) authorised medicinal product for other indications) is generally permissible within the scope of Articles 3 and 26 of the TPA. • Unlicensed use – an unlicensed medicinal product may be imported under the restrictive requirements of Article 20 paragraph 2 of the TPA and Articles 48 et seq of the MPLO. Manufacturers of medical devices must generally carry out a conformity assessment before placing the device on the market (see 3.4 Procedure for Obtaining a Marketing Authorisation ). However, in the interest of public health or patient safety or health, Swissmedic may – upon application – grant an authorisation even
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