14.09.2018
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 once the new legislation comes into force (scheduled for 1 January 2019). 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.
New application forms are being developed in order to implement these changes; these new forms will be available on the Swissmedic website from early November. Although applications using the new application forms will not officially be accepted until all the revised ordinances come into force on 1 January 2019, from 1 December 2018 Swissmedic will require any applications for variations or renewals which are to be implemented as of 1 January 2019 to be submitted using the new application forms. This will enable a quick changeover to the new system and ensure that all applications are handled within the usual time limits.
Licence renewal applications which should ordinarily be submitted in October or November 2018, in line with the prescribed 6-month time limit, may exceptionally be submitted in December 2018 (i.e. at the latest 4 months before their expiry) if the new application forms are used. Following the transfer of the existing operating licences to the new format as of January 2019, the existing time limit of 5 years maximum will not apply to any new licences issued. Thus an immediate changeover is in the best interests of the companies involved. Licences issued under current law will remain valid until their expiry.
Contact
For any questions, please call the Inspectorates and Licences Division on
+41 (0)58 462 04 55
or send an e-mail to
inspectorates@swissmedic.ch.