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:

SE 1    Patient diagnostics
     SE 1.1 Serology
  SE 1.2 Nucleic acid amplification (NAAT)
  SE 1.3 Cultivation and / or direct evidence
  SE 1.4 (particularities)
SE 2    Screening
  SE 2.1 Serology
  SE 2.2 Nucleic acid amplification (NAAT)
  SE 2.3 (particularities)
SE 3    Environmental analysis
  SE 3.1 Group 3 organisms
  SE 3.2 Group 4 organisms
  SE 3.3 (particularities)

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.

Errors

If you notice a mistake in the lists, please notify them to:

Swissmedic
Inspectorate and Licenses
Hallerstrasse 7
3012 Bern
Switzerland

inspectorates@swissmedic.ch

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/bewilligungen_zertifikate/microbiological-laboratories/bewilligungsinhaber.html