| Swissmedic - das Schweizerische Heilmittelinstitut Aufgaben in den Bereichen Zulassung, Qualität und GMP Dr. Hans Ulrich Gally Swissmedic, Schweizerisches Heilmittelinstiut, Bern (Schweiz)
Swissmedic, Swiss Agency for Therapeutic Products, that’s the full name of the new public agency of the Swiss Federation founded January 1st, 2002. At the same time the new federal law for therapeutic products came into force. All activities that concern medical products are n ow under direct control of the Federal Authorities of the Swiss Confederation. This agency was formed from the earlier Intercantonal Office for the Control of Medicines and departments of the Swiss Federal Office of Public Health. Swissmedic is responsible for the control of drugs, vaccines, blood, blood products, narcotics and medical devices.
The new law introduces several new regulations. After a short general introduction into the organisation and function of Swissmedic some important new regulations in the fields of drug production, registration of the part quality and GMP will be discussed and differences between EU-and Swiss regulations will be shown. |
