EU-GMP for Veterinary Medicinal Products: What will change in Switzerland?

The European Commission has published new implementing regulations on the GMP principles for veterinary medicinal products and their active substances. Both regulations came 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 currently applicable GMP requirements set out in the EU GMP Guidelines.

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).

How is this being implemented in Switzerland?

The EU requirements are not automatically transposed into the Swiss Medicinal Products Licensing Ordinance (MPLO), as the requirements remain largely the same. According to Swissmedic, 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.

Inspections in Switzerland will continue to be carried out in accordance with the applicable PIC/S guidelines, which are regarded as equivalent to the current EU GMP requirements.

Source: Swissmedic general communications