Licensing

Licensing of medicinal and transplant products

Companies that manufacture or distribute medicinal or transplant products in Switzerland (manufacturing, wholesale, import, export and trade in foreign countries) require an establishment licence. Swissmedic issues this licence on the basis of a successful inspection or other evaluation.

Special licences for medicinal and transplant products

On application and within 24 hours, Swissmedic issues medical professionals with a special licence for importing and using small quantities of medicinal and transplant products that are not authorised in Switzerland but are essential for the treatment of specific patients. The import, use or dispensing of these products is the sole responsibility of the medical professional in question.

GMP and GDP Inspections

Swissmedic and four regional Cantonal inspectorates carry out inspections as a prerequisite for issuing or maintaining a pharmaceutical establishment licence. They examine respect for the quality standards of Good Manufacturing Practice (GMP) on the part of manufacturers of pharmaceutical products and/or those of Good Distribution Practice (GDP) on the part of wholesale companies.

GCP/GVP inspections are performed by the GCP/GVP inspectorate which belongs to the department in charge of clinical trials on medicinal products. Details regarding the inspection process can be found under the heading clinical trials -> clinical trials on medicinal products -> GCP and GVP inspections.

Clinical trials of medicinal products and transplant products

Clinical trials may only be carried out in Switzerland if they have been approved by a Cantonal Ethics Committee, upon which Swissmedic is notified and is required to state any objections within 30 days (notification procedure). During the trials, adverse reactions and amendments must always be reported to the Ethics Committees and/or to Swissmedic.

Control of the flow of narcotics

Swissmedic issues establishment licences to companies and individuals that handle controlled substances. Accounting is mandatory for controlled substances. Swissmedic examines the annual accounts of all companies holding an establishment licence and draws up the International Narcotics Control Board (INCB) report in accordance with the international agreement. The import and export of controlled substances must be licenced in advance by Swissmedic.

Monitoring of the blood transfusion service

Swissmedic monitors Swiss blood transfusion activities by means of inspections, licences, market monitoring of devices and standardisation. The blood obtained from donors and the labile blood products manufactured from it are considered to be medicinal products in accordance with the Therapeutic Products Act. It is mandatory to have a Swissmedic licence for the collection of blood, the manufacturing of labile blood products and the distribution of labile blood products.

Official Medicines Control Laboratory (OMCL)

The accredited Swissmedic laboratory is responsible for the official batch release of stable blood products and vaccines, and supports the various sectors of Swissmedic by means of laboratory analysis and method developments and assessments.