Pursuant to the Epidemics Act (EpidA, SR 818.101), laboratories 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 microbiological laboratories 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 microbiological analyses on environmental samples (environmental analysis).
These laboratories must meet the requirements of the Ordinance on microbiology laboratories (SR 818.101.32). The establishment license is valid for five years and the renewal application must be submitted no later than six months before the license expires.
Main aspects concerning COVID-19 testing in Switzerland
The document “Merkblatt zur aktuellen COVID-19 Testung in der Schweiz _Swissmedic FOPH" was annulled at the beginning of November 2020. Since then, the FOPH publishes extensive information on COVID-19 testing and updates it regularly.
The essentials in brief
- This applies to those laboratories that perform microbiological analyses for the purpose of detecting or excluding human transmissible diseases.
- The legislation stipulates a mandatory establishment license issued by Swissmedic for these laboratories.
- Existing recognitions issued by the FOPH / establishment licenses issued by Swissmedic remain valid until their expiry or until changes are necessary.
- When applying for the first time, by changes or by renewals, a complete application with all enclosures must be submitted directly to Swissmedic.
- Significant changes to the license must be submitted to Swissmedic for approval using the official application forms.
- The renewal of recognitions issued by the FOPH / establishment licenses issued by Swissmedic must be submitted to Swissmedic six months before their expiry.