Guidance document Authorisation according to Art. 14 para. 1 abis-quater of the Therapeutic Products Act (TPA) updated

19. Januar 2024 – Swissmedic maintains its practice in respect of dispensing categories and classifies products in dispensing categories based on the current criteria. This means that the dispensing category may differ from that of the foreign comparator medicinal product. The practice was previously described in the “Questions and Answers” document and has now been included in section 5.1.7 of the guidance document. Based on the accumulated experience, Swissmedic has clarified the information regarding the requirements for the application documentation for authorisations according to Art. 14 para. 1 let. abis TPA (section 5.2.2). The table in Annex 1 has been added to provide an overview of the differences between the foreign reference medicinal product, the foreign comparator medicinal product and the medicinal product that is the subject of the application in Switzerland. The revised guidance document is valid with effect from 15 January 2024.

For more information, see here.