Modifications to guidance document "Formal requirements"

17 febbraio 2023 – 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 by Swissmedic. 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.

For more information, see here.