Text elements no longer need to be revised, submitted or approved by Swissmedic for applications for a change of status between main authorisation and export licence for veterinary medicinal products submitted on or after 1 September 2026. This applies to both the medicinal product information and the packaging texts.
Changes to the medicinal product information are no longer required for applications to convert a main authorisation into an export licence. Accordingly, this should also no longer be submitted to Swissmedic for approval.
Neither the packaging texts nor the medicinal product information must be submitted when converting an export licence to a main authorisation. Following the change of status, the veterinary medicinal product can be placed on the market with the packaging texts and the medicinal product information most recently approved by Swissmedic.
In addition, the medicinal product information of export licences no longer has to be published by the institution according to Art. 67 para. 3 TPA. This applies to future and existing export licences.
The relevant forms and guidance documents have been amended. The new requirements apply to all applications submitted on or after 1 September 2026.
Excerpt from the official page. The original is authoritative.