As part of a pilot, Swissmedic is now offering Preliminary Decision Clarification Meetings for applications for new authorisation or variation of the indication of medicinal products for human use with a new active substance (NAS). In the Preliminary Decision Clarification Meeting, applicants have an additional opportunity for dialogue with Swissmedic to clarify any questions or anything that is unclear regarding the preliminary decision.
Further information on how to request a pilot Preliminary Decision Clarification Meeting and its structure can be found in the Annex to the Guidance document Meetings for applications for authorisation procedures
Swissmedic has revised the Guidance document Meetings for applications for authorisation procedures, providing further clarification, particularly regarding the content of the Pipeline Meeting, and making editorial changes.
The revised Guidance document Meetings for applications for authorisation procedures will take effect on 1 June 2024.