Microbiological Laboratories

Useful information
The activities of a laboratory that require a license in the microbiological area are listed in an establishment license. This license is generally valid for five years and an application for renewal must be submitted to Swissmedic six months before the license expires.

Laboratories that perform or want to perform microbiological analyses must submit a corresponding application for approval to Swissmedic. Applicants have to use the official Swissmedic forms. To avoid that the application is considered not suitable, make sure that the forms are filled in correctly.

On the one hand, the application consists of a basic form in which general information about the applicant is requested:

On the other hand, for each operating site, information on the three main areas of analysis (patient diagnostics, screening, environmental analysis) must be announced on a supplementary sheet:

The application forms list the documents that, depending on the situation, need to be enclosed with the application (e.g., diploma copies, etc.).

Guidance document
The following guidance document provides assistance to applicants on how to submit their application for approval to Swissmedic.