To facilitate market authorisation of essential human medicines and counter possible supply shortfalls, Swissmedic will in future be offering its scientific and presubmission advice free of charge.
The new arrangement applies to all medicinal products containing active substances as specified in Annex 1 of the Ordinance on the Essential Human Medicines Reporting Office (SR 531.215.32).
From now on, therefore, companies can ask Swissmedic to clarify scientific regulatory issues concerning the authorisation of such medicinal products efficiently and free of charge.
For information about requesting and holding company meetings, please consult Guidance document Company meetings HMV4.
This arrangement enters into force with immediate effect.