Licences for microbiological laboratories

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». 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».