Swissmedic
Encyclopedia
Swissmedic, the Swiss Agency for Therapeutic Products, is the Swiss
surveillance authority for medicines and medical devices, registered in Berne
. It started 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
.
and was created by the Heilmittelgesetz (Therapeutic Products Act). It is independent in organization and management and has authority over its own budget. Swissmedic has 300 full-time employees.
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.
Switzerland
Switzerland name of one of the Swiss cantons. ; ; ; or ), in its full name the Swiss Confederation , is a federal republic consisting of 26 cantons, with Bern as the seat of the federal authorities. The country is situated in Western Europe,Or Central Europe depending on the definition....
surveillance authority for medicines and medical devices, registered in Berne
Berne
The city of Bern or Berne is the Bundesstadt of Switzerland, and, with a population of , the fourth most populous city in Switzerland. The Bern agglomeration, which includes 43 municipalities, has a population of 349,000. The metropolitan area had a population of 660,000 in 2000...
. It started 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
Federal Department of Home Affairs (Switzerland)
The Federal Department of Home Affairs is a department of the federal administration of Switzerland and serves as the Swiss ministry of the interior...
.
Structure
Swissmedic is a federal institution subject to public lawPublic law
Public law is a theory of law governing the relationship between individuals and the state. Under this theory, constitutional law, administrative law and criminal law are sub-divisions of public law...
and was created by the Heilmittelgesetz (Therapeutic Products Act). It is independent in organization and management and has authority over its own budget. Swissmedic has 300 full-time employees.
Functions
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.