The Swiss Agency for Therapeutic Products (Swissmedic) is the

Swiss Swiss may refer to: * the adjectival form of Switzerland * Swiss people Places * Swiss, Missouri * Swiss, North Carolina *Swiss, West Virginia * Swiss, Wisconsin Other uses *Swiss-system tournament, in various games and sports *Swiss Internation ...

surveillance authority for medicines and medical devices, registered in

Bern german: Berner(in)french: Bernois(e) it, bernese , neighboring_municipalities = Bremgarten bei Bern, Frauenkappelen, Ittigen, Kirchlindach, Köniz, Mühleberg, Muri bei Bern, Neuenegg, Ostermundigen, Wohlen bei Bern, Zollikofen , website ...

. 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 The Federal Department of Home Affairs (FDHA, , french: Département fédéral de l'intérieur, links=no, , rm, ) is a department of the federal administration of Switzerland and serves as the Swiss ministry of the interior. As of 2012, it is ...

Structure

Swissmedic is a federal institution subject to

public law Public law is the part of law that governs relations between legal persons and a government, between different institutions within a state, between different branches of governments, as well as relationships between persons that are of direct ...

and was created by the Federal Act on Medicinal Products and Medical Devices.Federal Act on Medicinal Products and Medical Devices
()page visited on 10 August 2013. 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 Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

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

External links

Official website

Swissmedic Guidances
{{Coordinate, NS=46.9523, EW=7.4355, region=CH-BE, type=landmark Pharmaceuticals policy Medical and health organisations based in Switzerland Federal Department of Home Affairs National agencies for drug regulation