Swissmedic: Implementation of New EU GMP Implementing Regulations for Veterinary Medicinal Products
The new EU Implementing Regulations on GMP requirements for veterinary medicinal products and active substances will not be automatically transposed into the Swiss Medicinal Products Licensing Ordinance (MPLO) on 16 July 2026. Swissmedic has confirmed that, although the structure of the new EU legislation has changed, the underlying GMP requirements remain largely unchanged.
Swissmedic therefore considers the new EU Implementing Regulations to be equivalent to the current PIC/S GMP Guidelines and the identically worded EU GMP Guide. As a result, GMP inspections in Switzerland will continue to be conducted in accordance with the applicable PIC/S/EU requirements.
The authority also confirmed that the changes have no impact on the existing Mutual Recognition Agreement (MRA) between Switzerland and the European Union. During the next revision of the MPLO, Swissmedic will assess whether it is appropriate to include a reference to the new EU Implementing Regulations.
Source:
Swissmedic: EU: New GMP Implementing Regulations for Veterinary Medicinal Products
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