The European Commission has published new implementing regulations on the principles of Good Manufacturing Practice (GMP) for veterinary medicinal products and for active substances used as starting materials in veterinary medicinal products. Both regulations will enter into force on 16 July 2026. They set out in detail the requirements of Regulation (EU) 2019/6 on veterinary medicinal products and replace the current GMP requirements set out in the EU GMP Guidelines.
Manufacture of veterinary medicinal products:
Manufacture of active substances as starting materials for veterinary medicines:
Despite the different legal bases of the EU implementing regulations, the GMP requirements for veterinary medicinal products and their active substances remain aligned with those for medicinal products for human use and their active substances. Corresponding comparison tables can be found on the EudraLex website. The GMP requirements previously applicable to the manufacture of veterinary medicinal products and their active substances as starting materials are also set out in the relevant PIC/S guidelines (PE 009-17 Part I and Part II).
The new EU implementing regulations will not be automatically transposed into the Medicinal Products Licensing Ordinance (MPLO) as of 16 July 2026. Although the structure of the new EU regulations has changed, the content – or rather the requirements – remain largely the same. Consequently, the new EU regulations are regarded as equivalent to the current PIC/S GMP guidelines. Accordingly, the inspections in Switzerland will continue to be carried out in accordance with the applicable PIC/S guidelines. The changes currently have no impact on the existing Mutual Recognition Agreement (MRA) with the EU.
During the next revision of the MPLO, consideration will be given to whether it is appropriate to include a reference to the new EU implementing regulations.