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.
The terms "foreign comparator medicinal product" and "foreign reference medicinal product" have been included in the definitions (section 1.1) and used consistently throughout the 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.
There have also been some changes to wording and some further explanations have been added regarding the content, but these do not involve any new requirements for the applicant.
The revised guidance document is valid with effect from 15 January 2024.