Pursuant to the Epidemics Act (EpidA, SR 818.101), facilities that perform or want to perform microbiological analyses for the purpose of detecting or excluding human transmissible diseases are required to hold an establishment license issued by the Swiss Agency for Therapeutic Products.
This applies to facilities that:
- perform diagnostic and epidemiological analyses (patient diagnostics);
- carry out microbiological analyses to rule out a disease that can be transmitted by blood, blood products or grafts (screening);
- offer for the detection of a pathogen in environmental samples in association with B events (environmental analysis).
The requirements of the Ordinance on microbiology laboratories (SR 818.101.32) must be met in order to obtain a corresponding establishment license.
The establishment license as a microbiological laboratory is valid for a maximum of five years and the renewal application must be submitted no later than six months before the license expires.
Swissmedic periodically checks whether the licensed microbiological laboratories comply with the legal provisions.
The cantons of the operating sites are informed about the granting, renewal, suspension, restriction or withdrawal of establishment licenses, as well as about inspections.