20.03.2018 - The ongoing revision of the Ordinance on Licensing in the Medicinal Products Sector (MPLO) in connection with the ordinary revision of the Therapeutic Products Act (TPA 2) and the Medicrime Convention of the Council of Europe necessitates amendments to the three ordinances of the Swiss Agency for Therapeutic Products. Swissmedic is holding a consultation procedure on these amendments until 25 May 2018.
Swissmedic opens the consultation procedure on the amendment of ordinances of the Swiss Agency for Therapeutic Products in connection with the implementation of the Medicrime Convention
The minor amendments to the ordinances arise from the proposal adopted by Parliament on 29 September 2017 to approve and implement the Medicrime Convention and, in connection with this and following the ordinary revision of the Therapeutic Products Act (2nd phase) adopted on 18 March 2016, the complete revision of the Medicinal Products Licensing Ordinance (MPLO; SR 812.212.1), which is simultaneously being forwarded for consultation by the Federal Department of Home Affairs (FDHA). Both revision proposals are to be harmonised with each other in terms of timing and substantive content where necessary.
In order to ensure coordinated implementation with the Therapeutic Products Ordinance Package IV, the consultation procedure of the Swiss Agency for Therapeutic Products on the consolidation legislation will be abbreviated: The consultation period lasts from 20 March 2018 to 25 May 2018.
Documentation for the consultation procedure
The consultation documentation (draft ordinance, explanations and the list of addressees to be consulted) can be downloaded from www.admin.ch/ch/d/gg/pc/pendent.html
Statements
Statements on the amendments to the ordinances of the Swiss Therapeutic Products Agency in connection with the entry into force of the Medicrime Convention should be sent during the consultation period to the following e-mail address using the Word form provided (please state contact person for any queries): AMBV_MC@swissmedic.ch
The Medicrime Convention of the Council of Europe is designed to avert threats to public health resulting from counterfeit therapeutic products (medicinal products and medical devices). Although Switzerland already largely meets the requirements of the Convention, ratification necessitates individual amendments to the Therapeutic Products Act (TPA) and the Criminal Procedure Code (CPC).
Further links
Sicherheit und Rückverfolgbarkeit von Arzneimitteln werden gestärkt
Medicrime Convention & European «Falsified Medicines Directive»
Ordinary Revision of the Therapeutic Products Act (Stage 2) and right of enforcement
Council of Europe – MEDICRIME Convention
Contact
Dr. Philippe Girard
Head of Licensing
philippe.girard@swissmedic.ch
+41 58 462 02 42
Matthias Stacchetti
Head of Penal Division
matthias.stacchetti@swissmedic.ch
+41 58 462 08 27