Changes to the Guidance document Meetings for applicants for authorisation procedures

7. Juni 2024 – 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.

For more information, see here.