SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
• 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 authorisation 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 para- graph 1 lit f TPA). • Temporary authorisation for use outside of clinical trials – Swissmedic may temporar- ily 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 temporarily or quantitatively authorised by Swissmedic to bridge the unavailability of an identical medicinal product in Switzerland, provided that they are authorised in another country with an equivalent medicinal product control and no essentially identical medicinal product is authorised and available in Swit- zerland (Article 9b paragraph 2 of the TPA). • Off-label use (eg, the use of a (properly) authorised medicinal product for other indi- cations) 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 gener- ally carry out a conformity assessment before placing the device on the market (see 3.4 Pro- cedure for Obtaining a Marketing Authorisa- tion for Pharmaceuticals and Medical Devic- es ). However, in the interest of public health or patient safety or health, Swissmedic may – upon application – grant an authorisation even though
the relevant conformity assessment procedure has not been carried out (Article 22 paragraph 1 of the MedDO and Article 18 paragraph 1 of the IvDO). 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations Holders of marketing authorisations for medici- nal products, as well as medical device manu- facturers, must have a post-market surveillance system (ie, pharmacovigilance and materiovigi- lance plans) in place (Article 11 paragraph 2 lit a no 5 of the TPA, Article 56 of the MedDO, and Article 49 of the IvDO). Holders of marketing authorisations for medici- nal products with a new API or a biosimilar must automatically file periodic safety update reports (PSURs) with Swissmedic on the safety and risk-benefit ratio for four years after authorisa- tion (Article 60 of the OMP). With its marketing authorisation, Swissmedic may impose addi- tional conditions or obligations on the appli- cant, including further product evaluations (eg, in Phase IV clinical trials). Depending on the clas- sification of a medical device, its manufacturer has similar trend report, periodic summary report and PSUR obligations to the designated body involved in the conformity assessment (Articles 59 et seq of the MedDO and Articles 52 et seq of the IvDO). As for incident notification requirements, manu- facturers of medicinal products, distributors of ready-to-use medicinal products, and HCPs must notify Swissmedic of adverse events, adverse drug reactions, and quality defects within 15 days in the event of serious adverse reactions and within 60 days in the event of non-serious reactions. Similarly, anyone plac- ing medical devices on the Swiss market must
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