As part of cost containment package 1b, Parliament approved a new paragraph 3 in Art. 14 of the Therapeutic Products Act (TPA, 812.21) on 30 September 2022. This provides for additional simplifications for parallel imported medicinal products. Implementation has meant the revision of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (TPLO, SR 812.212.23). The revised provisions enter into force on 1 January 2024.
The approved simplifications will reduce the costs of parallel imports for marketing authorisation holders without compromising patient safety. The rights and obligations regarding authorisation of parallel imports therefore remain comparable to those of all other marketing authorisation holders. For example, for the purposes of effective market surveillance, it is always clear who is responsible for a parallel imported medicinal product.
As an alternative to repackaging medicinal products from the foreign into Switzerland-specific packaging, which was previously necessary for parallel imports, the new regulation makes it possible to affix a label with the required Swiss information to the foreign pack. Furthermore, the Swiss package leaflet can be enclosed in a suitable form (e.g. using banding) without removing the package leaflet from the original foreign packaging.
Swissmedic has amended the requirements for parallel imports of human medicinal products already authorised in Switzerland in the guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) accordingly. The form Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) and others have also been updated.
The new guidance document and the amended forms will apply from 1 January 2024.