Swissmedic issues establishment licences for TpP/GT according to the Therapeutic Products Act (TPA, SR 812.21) and the Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1)
Legal basis
According to Articles 5, 18, 28 and 34 of the Therapeutic Products Act (TPA, SR 812.21) and Article 1 para. 2 of the Medicinal Products Licensing Ordinance (MPLO; SR 812.212.1), companies that
- manufacture or distribute transplant products (TpP), gene therapy products (GT) and/or genetically modified organisms (GMOs),
- perform brokerage or agency activities for such products,
must obtain an establishment licence from Swissmedic.
Company names and registered offices
The company names and addresses that appear in this list are those entered in the Commercial Register (if such an entry exists). The establishment licences are always issued to the legal entity stated in the Commercial Register.
Date of validity of establishment licences
Swissmedic issues establishment licences for an unlimited duration, with few exceptions.
Verification of validity
Suppliers and customers must check their business partners' establishment licences. In general the approved establishment licence applies.
It is also possible to check establishment licences using the SwissGMDP database https://swissgmdp.ch/.
List of establishment licences
All establishment licence holders can be found in the SwissGMDP database.
A list of establishment licence holders can also be generated there. See