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.
Licensing of medicinal and transplant products
Special authorisations
From 1 September 2022, Swissmedic will no longer issue authorisations for the import of veterinary medicinal products by medical professionals (“special authorisations”). The reason for this is the adaptation of the Veterinary Medicinal Products Ordinance (VMPO, SR 812.212.27, valid from 01 July 2022).
Therefore, notifications or applications for the import of veterinary medicinal products should be made to the Federal Food Safety and Veterinary Office (FSVO) from now on. For further information, please visit the FSVO website using the following link:
[not available in English]
Microbiological laboratories
As of 2016, and pursuant to the Epidemics Act, laboratories that conduct, or would like to conduct, microbiological investigations for the purpose of detecting transmissible diseases are required to hold a licence issued by the Swiss Agency for Therapeutic Products. These laboratories must meet the requirements of the Ordinance on Microbiology Laboratories (SR 818.101.32). The licence is valid for a maximum of five years and must be renewed, at the latest, six months before it expires. Swissmedic periodically checks whether the laboratories comply with the legal provisions.
04.05.2021
International trade with wholesalers outside the EU
Licence holders required to check suppliers more rigorously
01.11.2020
New eGov service for electronic notification of major changes
25.09.2020
23.07.2020
Changeover to electronic submission of notifications of major changes from autumn 2020
Planned changes affecting establishment licence holders
14.09.2018
Last modification 29.08.2022