Establishment licence holder

Legal basis
Pursuant to Art. 16 or the Epidemics Act (EpidA, SR 818.101), laboratories that perform microbiological analyses for the purpose of detecting or excluding transmissible diseases are required to hold an establishment license issued by Swissmedic.

At least once a year, the Swiss Agency for Therapeutic Products publishes a list of laboratories that have been licensed under Art. 22 of the Ordinance on microbiology laboratories (SR 818.101.32).

Holders of establishment licenses appear in the above list. The analysis areas and activities (per operating site) are listed as follows:

The list contains the following information:

• Name and address of the laboratory
• Name of the laboratory manager
• Analytical testing services provided

Date of validity of establishment licenses and pending applications
The expiry date of establishment licenses for microbiology laboratories is published in the list. The establishment license is valid for five years and the renewal application must be submitted no later than six months before the license expires.

Validity
Establishment licenses are the sole legally authoritative documents. Suppliers and customers must therefore always inspect their business partners’ establishment license. The list is published solely for information purposes and does not in any way absolve suppliers and customers from their duty to exercise due care, especially in view of the fact that the list does not mention certain restrictions.

If an activity has been erroneously assigned to a company in the list, the company in question cannot demand that Swissmedic issues or upholds a license for this activity.

Confirmation of laboratory establishment licenses
Since 1 September 2023, the entire Swiss COVID certificate system has definitively ceased operations due to the repeal of the COVID-19 Certificates Ordinance. As a result, COVID certificates based on testing will no longer be issued for travel either. Swissmedic in turn has therefore decided, with immediate effect, to no longer issue the confirmation of laboratory establishment licenses in English to licensed microbiological laboratories in Switzerland, which certified their suitability to carry out analyses for the diagnosis of COVID-19. The license holders and their areas of analysis can be viewed by the public in the list at the top of this website.