Modifications to guidance document "Formal requirements"


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 authorisation to a stand-alone authorisation have been clarified. The Questions and Answers on Co-Marketing HMP and on Variations and Extensions HMP have been updated accordingly.

In addition, due to the revision of the Fees Ordinance, it is now possible to apply for fulfilment of conditions as a collective application, provided these conditions were ordered in relation to a collective application.

Other editorial changes have also been made as part of the update to the guidance document.

The revised guidance document Formal requirements is valid with effect from 15 February 2023.