Establishment licences
Firms that manufacture or distribute medicinal or transplant products in Switzerland, including for import, wholesale, export and commercialisation abroad, require an establishment licence granted by Swissmedic.
The licences are granted following successful inspections.

Notification of clinical trials
Clinical trials with medicines, transplant products and certain medical devices may only be carried out in Switzerland once they have been approved by the relevant Cantonal Ethics Committee and once Swissmedic has issued the relevant notification. During the trial, all adverse drug reactions and discrepancies must be reported to the Ethics Committee and/or Swissmedic.

Special licences
Swissmedic grants special licences, on application, to medical professionals for the importation and use of medicinal products that are not authorised in Switzerland.

Pharmacopoeia
The pharmacopoeia valid in Switzerland consists of the European Pharmacopoeia (Ph. Eur.) and the Swiss pharmacopoeia (Ph. Helv.). The quality regulations contained therein (general notices, test methods and specific monographs) constitute the fundamental basis of a standardised, harmonised quality assurance for important medicines. They are legally binding and thus constitute a significant prerequisite for guaranteeing that all therapeutic products are of high quality.

Narcotics
Firms and individuals that cultivate, produce, process or market narcotics, psychotropic substances and precursor chemicals (including import / export) require an operating licence from Swissmedic. The licences are granted following successful inspections. Swissmedic must be notified of every delivery of narcotics within Switzerland. All narcotics must be entered into a registration system.
The import and export of narcotics, psychotropic substances and precursor chemicals require a separate licence granted by Swissmedic.

Blood and labile blood products
Blood obtained from the donor system and the labile blood products produced from it are classified as medicines in accordance with the Therapeutic Products Act. Activities such as collecting blood, manufacturing labile blood products or distributing labile blood products require a permit granted by Swissmedic. In addition, a Cantonal permit is required if the activity concerns the storage of blood products alone.
The Swiss blood donor system is supervised by the Inspectorates department and is based on inspections, permits, market monitoring and standardisation processes.

Laboratory (OMCL)
The laboratory, which has ISO 17025 certification, is responsible for the official batch release of stable blood products and vaccines, and provides support to all Swissmedic divisions in terms of laboratory analysis, method developments, method assessments and medicines.

Transplant products
The Transplant unit is responsible for the control of transplant products. These products from somatic cell therapy, tissue engineering and ex vivo gene therapy are, in accordance with the Federal Act on Transplants (TxG, SR 810.21), considered as medicines and are thus governed by the Therapeutic Products Act. The provisions of the said law regarding establishment licences, clinical trials, operating permits, advertising, vigilance and administrative measures therefore apply accordingly. As mandated by the Federal Office of Public Health, inspections are moreover carried out at firms and institutions that work with cells, tissue and organs.