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 transmissible diseases are required to hold an establishment licence issued by Swissmedic.

Each 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).

Following the entry into force of the new Therapeutic Products Act (TPA, SR 812.21) and the revised Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1), establishment licences for microbiology laboratories granted from 1 January 2019 have been issued under a new process.

Holders of establishment licences issued under the new process appear in the following list:

  • “Laboratory establishment licences issued under the new process”.

Laboratory establishment licences issued under the old legislation will retain their validity until their expiry date. Holders of establishment licences issued under the old process appear in the following list:

  • “Laboratory establishment licences issued under the old process”.

During the transitional period lasting until all establishment licences issued under the old process and not renewed under the new process have expired, it should be borne in mind that a licence holder may appear in either of the two published lists. 

These lists contain the following information:

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

Date of validity of establishment licences and pending applications
The “Date” column in the “Laboratory establishment licences issued under the old process” list shows the expiry dates of establishment licences issued to microbiology laboratories under the old process. 

Validity
Establishment licences are the sole legally authoritative documents. Suppliers and customers must therefore always inspect their business partners’ establishment licence. The lists are published solely for information purposes and do not in any way absolve suppliers and customers from their duty to exercise due care, especially in view of the fact that the lists do not mention certain restrictions.
If an activity has been erroneously assigned to a company in one of the lists, the company in question cannot demand that Swissmedic issue or uphold a licence for this activity.

Errors

If you notice a mistake in the list, please write to:

Swissmedic
Division Inspectorates and Licenses
Hallerstrasse 7
3012 Bern
or

inspectorates@swissmedic.ch

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/besondere-arzneimittelgruppen--ham-/transplant-products/authorization-holder.html