Revision of the guidance document 'Renewal and discontinuation of authorisation or change of status (main authorisation / export licence)'

01.09.2025

Swissmedic clarifies the requirements for the renewal and change of status of medicinal product authorisations. Several documents have been revised, simplified or archived.

The guidance document Renewal and discontinuation of authorisation or change of status (main authorisation / export licence) has been clarified and editorially revised. Changes included clarification of the requirements relating to pack sizes when converting an export licence to a main authorisation.

Information on the renewal of authorisations according to Article 85 of the Ordinance of 21 September 2018 on Therapeutic Products (SR 812.212.21) was removed, since all the authorisations concerned have now been renewed at least once. The relevant information has also been deleted accordingly from other Swissmedic documents (see list below).

As a result of these changes, the forms Renewal of authorisation CHM and Renewal of authorisation by notification procedure VMP have been archived since the general Renewal of authorisation form now also applies to human and veterinary medicinal products used in complementary medicine.

The revised guidance document, the Overview of documents to be submitted and the updated Renewal of authorisation form are valid with effect from 1 September 2025.

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