On 1 June 2024, Swissmedic launched the Preliminary Decision Clarification Meeting as a pilot. Swissmedic has analysed the meetings conducted since then and will definitively introduce the Clarification Meeting after a preliminary decision for human medicinal products on 1 October 2025.
In the Preliminary Decision Clarification Meeting, applicants have an additional opportunity for dialogue with Swissmedic to clarify any comprehension questions relating to the concerns communicated by Swissmedic in the preliminary decision. A scientific dialogue with Swissmedic on the applicant's planned response strategy is also possible.
Further information on how to request the Preliminary Decision Clarification Meeting and its structure can be found in the guidance document Meetings for applicants for authorisation procedures.
The updated guidance document Meetings for applicants for authorisation procedures will take effect on 1 October 2025.