SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd
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 Ongoing Obligations Imposed by Marketing Authorisations Holders of marketing authorisations for medicinal products, as well as medical device manufacturers, must have a post-market surveillance system (ie, pharmacovigilance and materiovigilance 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 medicinal products with a new API or a biosimilar must auto- matically file periodic safety update reports (PSURs) with Swissmedic on the safety and risk-benefit ratio for four years after authorisation (Article 60 of the OMP). With its marketing authorisation, Swissmedic may impose additional conditions or obligations on the applicant, 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, manufactur- ers of medicinal products, distributors of ready-to-use medicinal products, and HCPs must notify Swiss- medic 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 placing medi- cal devices on the Swiss market must report to Swiss- medic all serious incidents as well as all field safety corrective actions that are undertaken in Switzerland (Article 66 of the MedDO and Article 59 of the IvDO). 3.7 Third-Party Access to Pending Applications for Marketing Authorisations Authorities must, in principle, treat all data collected within the framework of the TPA and its implement- ing regulations as confidential, including all data communicated to the authorities in the context of a marketing authorisation application (Article 62 of the TPA). Granted marketing authorisations for medicinal
products are published in the monthly Swissmedic Journal, together with essential information about the medicinal product. Swissmedic publishes an assess- ment report (SwissPAR) for all medicinal products with a new API – as well as for transplant products – for which a decision to approve or reject authorisation has been issued. The SwissPAR includes the evalua- tion results of the application for new authorisation or additional indication of a medicinal product, but not the applicant’s commercial or manufacturing secrets or personal data. Regarding medical devices, the conformity assess- ment procedures by Swiss or European assessment bodies are not accessible to third parties. The suc- cessful completion of a conformity assessment is made public together with the issuance of the decla- ration of conformity for the respective product (Article 90 lit f of the MedDO). 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes Medicinal Products For the approval of a human medicinal product, a fast track procedure may be conducted. Unlike the standard procedure, the fast track procedure requires a previously approved request for the implementation of this procedure. Once such a request is received, Swissmedic will determine within 30 days whether the criteria for the fast track procedure are met (Article 7 of the OMP) (see Section 14.4 of Swissmedic guidance document “Fast-Track Authorisation Procedure”). To qualify for a fast track authorisation procedure for a human medicinal product, the following criteria must be met. • The medicinal product must provide promising prevention or treatment for a severe, disabling, or life-threatening disease (Article 7 lit a of the OMP). • No currently authorised medicinal product exists for the condition, or existing treatments are unsat- isfactory (Article 7 lit b of the OMP). Authorised medicinal products may be deemed unsatisfactory owing to various factors, including limited effec-
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