Swissmedic Annual Report 2017: achieving success through collaboration
According to Stéphane Rossini, incoming Chairman of the Agency Council, the culture of collaboration will remain a factor in ensuring that Switzerland is successful in retaining a high-quality medicines control system: “A globalised economy and the international consumption of therapeutic products entail synergies and collaboration.”
According to Stéphane Rossini, incoming Chairman of the Agency Council, the culture of collaboration will remain a factor in ensuring that Switzerland is successful in retaining a high-quality medicines control system: “A globalised economy and the international consumption of therapeutic products entail synergies and collaboration.”
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Licensing<br />
Licensing of medicinal and transplant products 37<br />
Establishment licences for medicinal and transplant products 37<br />
Special licences for medicinal and transplant products 37<br />
Certificates for medicinal and transplant products 38<br />
Control of the flow of narcotics 38<br />
Clinical trials with medicinal products and transplant products 39<br />
Clinical trials with transplant products, medicinal products for gene therapy<br />
and genetically modified organisms (TpP / GT / GMO) 40<br />
Inspections 41<br />
GMP and GDP inspections 41<br />
GCP and GVP inspections 42<br />
GLP inspections 43<br />
Inspections for third parties 43<br />
Inspections by foreign authorities in Switzerland 44<br />
Monitoring of the blood transfusion service 44<br />
Licensing of microbiological laboratories 45<br />
Establishment licences for microbiological laboratories 45<br />
Inspections of microbiological laboratories 45<br />
Official Medicines Control Laboratory (OMCL) 46<br />
Analysis conclusions for new marketing authorisations and market monitoring 47<br />
Appeals procedures regarding licences 47<br />
Special activities and events: Authorisation 48<br />
Market surveillance<br />
Medicinal products<br />
Medicinal product vigilance 49<br />
Pharmacovigilance 49<br />
Haemovigilance 50<br />
Vigilance for veterinary medicinal products 51<br />
Risk management 52<br />
Risk mitigation measures 53<br />
Quality defects and batch recalls 54<br />
Measures against illegal medicinal products 54<br />
Control of advertising 56<br />
Appeals procedures regarding the market monitoring of medicinal products 56<br />
Special activities and events: Market surveillance for medicinal products 57<br />
Medical devices 58<br />
Market monitoring of medical devices 58<br />
Integration within the European system 58<br />
Placing on the market 59<br />
European market monitoring activities 60<br />
Materiovigilance 60<br />
Market controls 61<br />
Clinical investigations 61<br />
Monitoring of conformity assessment bodies (CABs) and inspections 62<br />
Export certificates 62<br />
Appeals procedure concerning the market monitoring of medical devices 62<br />
Special activities and events: Market monitoring of medical devices 63
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