The Swiss Agency for Therapeutic Products (Swissmedic) is the Swiss surveillance authority for medicines and medical devices, registered in Bern. It began operations on 1 January 2002 as successor of Interkantonale Kontrollstelle für Heilmittel (IKS), which was itself the successor of Schweizerische Arzneimittelnebenwirkungszentrale (SANZ). Swissmedic is affiliated to the Federal Department of Home Affairs.
Swissmedic is a federal institution subject to public law and was created by the Federal Act on Medicinal Products and Medical Devices.[1] It is independent in organization and management and has authority over its own budget. Swissmedic has 300 full-time employees.
FunctionsEdit
Any medical products for humans or animals need approval from Swissmedic to be brought on the Swiss market. Moreover, Swissmedic must be notified of all clinical studies conducted in Switzerland.
When authorising new medicinal products, Swissmedic bases its decisions on internationally acknowledged criteria. The products may only be placed on the market if their quality, safety and effectiveness are sufficiently evaluated and proved. If the criteria for authorisation are fulfilled, Swissmedic grants the marketing authorisation, specifies the method of sale (on prescription only/dispensing point) and approves the information for healthcare professionals and the patient information.
Costs of approval are paid by the applicant. Approval must be renewed after five years.
Notes and referencesEdit
^Federal Act on Medicinal Products and Medical Devices
swissmedic, swiss, agency, therapeutic, products, swiss, surveillance, authority, medicines, medical, devices, registered, bern, began, operations, january, 2002, successor, interkantonale, kontrollstelle, für, heilmittel, which, itself, successor, schweizeris. The Swiss Agency for Therapeutic Products Swissmedic is the Swiss surveillance authority for medicines and medical devices registered in Bern It began operations on 1 January 2002 as successor of Interkantonale Kontrollstelle fur Heilmittel IKS which was itself the successor of Schweizerische Arzneimittelnebenwirkungszentrale SANZ Swissmedic is affiliated to the Federal Department of Home Affairs Logo of Swissmedic Contents 1 Structure 2 Functions 3 Notes and references 4 External linksStructure EditSwissmedic is a federal institution subject to public law and was created by the Federal Act on Medicinal Products and Medical Devices 1 It is independent in organization and management and has authority over its own budget Swissmedic has 300 full time employees Functions EditAny medical products for humans or animals need approval from Swissmedic to be brought on the Swiss market Moreover Swissmedic must be notified of all clinical studies conducted in Switzerland When authorising new medicinal products Swissmedic bases its decisions on internationally acknowledged criteria The products may only be placed on the market if their quality safety and effectiveness are sufficiently evaluated and proved If the criteria for authorisation are fulfilled Swissmedic grants the marketing authorisation specifies the method of sale on prescription only dispensing point and approves the information for healthcare professionals and the patient information Costs of approval are paid by the applicant Approval must be renewed after five years Notes and references Edit Federal Act on Medicinal Products and Medical DevicesExternal links EditOfficial website Swissmedic Guidances 46 57 08 N 7 26 08 E 46 9523 N 7 4355 E 46 9523 7 4355 Retrieved from https en wikipedia org w index php title Swissmedic amp oldid 1162697624, wikipedia, wiki, book, books, library,
