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: