New Swissmedic application forms for operating licences

Claude Ammann – March 17, 2019

Owing to the revision of the therapeutic products legislation and the complete revision of the Medicinal Products Licensing Ordinance, a number of basic terms have been altered which will necessitate changes to the operating licences for the manufacture and distribution of medicinal products and transplant products. At the same time, Swissmedic is adjusting the presentation of the various activities to comply with the European manufacturing licence format and thus facilitate the entry of information concerning licences and certificates into the European EudraGMDP database.