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.
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 licenses for microbiology laboratories granted from 1st January 2019 have been issued under a new process.
Holders of establishment licenses issued under the new process appear in the following list:
- «Laboratory establishment licenses issued under the new process».
The analysis areas and activities (per operating site) issued under the new process are listed as follows:
Laboratory establishment licenses issued under the old legislation will retain their validity until their expiry date. Holders of establishment licenses issued under the old process appear in the following list:
- «Laboratory establishment licenses issued under the old process».
During the transitional period lasting until all establishment licenses issued under the old process and not renewed under the new process have expired, it should be borne in mind that a license 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 licenses and pending applications
The expiry date of establishment licenses for microbiology laboratories is published in the respective 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 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 issues or upholds a license for this activity.
Confirmation of laboratory establishment licenses in English
The Swiss Agency for Therapeutic Products issues a confirmation of laboratory establishment licenses in English to licensed laboratories in Switzerland. The confirmation certifies as well the suitability to carry out analyses for the diagnosis of COVID-19 and refers to the lists of licensed laboratories published by Swissmedic. Orders are placed by the relevant license establishment holders by e-mail to the following address: microbiolabs@swissmedic.ch. Confirmations are printed on bond paper and sent by post. They are valid for 12 months.
