With effect from 1 September 2026, Swissmedic has simplified applications for a change of status between a main authorisation and an export licence for veterinary medicinal products. For applications submitted on or after that date, amendments to text elements – both the medicinal product information and the packaging texts – are no longer required For applications to convert a main authorisation into an export licence, amendments to the medicinal product information are no longer necessary and no longer need to be be submitted to Swissmedic for approval. Conversely, when converting an export licence into a main authorisation, neither the packaging texts nor the medicinal product information must be submitted.Following the change of status, the veterinary medicinal product may be placed on the market with the packaging texts and medicinal product information most recently approved by Swissmedic.

In addition, the medicinal product information for export licences no longer needs to be published by the institution referred to in art. 67 para. 3 of the Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA).This applies to both future and existing export licences. The relevant forms and guidance documents have been amended accordingly.

For more information, see here.