Since 16 July 2026, good manufacturing practice for veterinary medicinal products has been set out in directly applicable EU law rather than in guidance. Commission Implementing Regulation (EU) 2025/2091 covers GMP for veterinary medicinal products, and Commission Implementing Regulation (EU) 2025/2154 covers GMP for active substances used as starting materials in them. Both entered into force on 16 November 2025 and became binding on 16 July 2026.
Guidance became law
The practical change is one of legal status. Veterinary GMP expectations previously sat in the EU GMP Guidelines, which national authorities applied as guidance. The two implementing regulations set out in detail the manufacturing requirements of Regulation (EU) 2019/6 and are directly applicable in every Member State without national transposition. There is no implementation law to wait for and no national interpretation to argue over.
Is this a rewrite of your quality system?
For most manufacturers, no. The structure of the requirements has changed, but the substance of what is expected has largely carried across from the existing GMP guidelines, and the new regulations are regarded as equivalent to the current PIC/S GMP guidance. A site operating a mature, genuinely applied quality system is unlikely to discover a fundamental gap. What it will discover is that its documentation points at the wrong source.
What actually needs to change
- References. Standard operating procedures, quality manuals, validation plans and training material that cite the old guideline structure need to be repointed at the regulations and their article numbering.
- Quality agreements and contracts. Manufacturing and supply agreements that define GMP by reference to the previous framework should be reviewed and, where necessary, amended.
- Active substance oversight. Regulation (EU) 2025/2154 puts the expectations for active substances used in veterinary products on the same directly applicable footing. Supplier qualification files and audit programmes should reflect that.
- Gap assessment on record. Even where the answer is “no change required”, inspectors will expect to see a documented assessment that reached that conclusion, not an assumption.
- Training. Staff need to know which framework they are working to, and the training record needs to show when that changed.
The inspection angle
Because the change is structural rather than substantive, the realistic inspection risk is not a failure of manufacturing control. It is a documentation system that still describes a framework that no longer applies, and a site that cannot demonstrate it noticed the transition. That is an avoidable finding, and it is the kind that suggests weak regulatory intelligence rather than weak manufacturing.
How PQRA helps
PQRA carries out GMP gap assessments against the new veterinary regulations, updates quality documentation and quality agreements, reviews supplier qualification for active substances, and prepares sites for inspection by national competent authorities. We work with manufacturers, importers and marketing authorisation holders who rely on contract sites and need assurance that their partners have made the transition properly.
To review your veterinary manufacturing compliance against the new framework, contact PQRA.
No responses yet