The revised implementing ordinances (Therapeutic Products Ordinance Package IV) for the ordinary revision of the Therapeutic Products Act (TPA 2) will come into force on 1 January 2019. As a result of the revision, Swissmedic has adapted the documents for authorisation applications.
Revision of the Therapeutic Products Act (TPA): Publication of the specification documents and forms for authorisation applications
30.09.2018
Adapted authorisation documents and their entry into force
The adapted documents which will be valid from the entry into force can be found on the Swissmedic website under “Documents and Forms”. In addition, the documents valid until the end of 2018 are still available for applications under the old law.
The documents are based on the revised implementing ordinances of the Therapeutic Products Ordinance Package IV (German abbreviation: HMV IV) which were published on 21 September 2018.
Applications under the new legislation will be accepted from 1 December 2018 at the earliest.
For applications under the new legislation submitted before 1 January 2019, a submission date of 3 January 2019 will apply (start of deadline period).
Publication of documents for establishment licence applications
The adapted forms for establishment licence applications will be published on 1 November 2018 as part of the revision of the MPLO/Medicrime.
Links
Information events
For further information concerning the revision of the Therapeutic Products Act, we recommend attending the information events on the TPA revision, to be held on 25 October and 9 November 2018. More details on the organisation as well as the event programme can be found in the event announcement.
Supplementary information
Ordinary Revision of the Therapeutic Products Act (Stage 2) and right of enforcement
Federal Office of Public Health FOPH
Medicrime Convention & European «Falsified Medicines Directive»
Federal Office of Public Health FOPH