Modifications to Guidance Document "Formal Requirements"

13 February 2023 – the Swissmedic published clarification of documentation to be submitted for co-marketing medicinal products; conditions can be the subject of collective applications.

Regarding co-marketing medicinal products, the documents to be submitted for conversion of a co-marketing authorization to a stand-alone authorization have been clarified. The Questions and Answers on Co-Marketing HMP and on Variations and Extensions HMP have been updated accordingly.