The European Union’s Veterinary Good Manufacturing Practice (GMP) framework is undergoing development. The European Union regulation, which establishes requirements for all Marketing Authorisation Holders and manufacturers, will become effective on July 16 2026, according to the veterinary medicinal product regulations defined in Regulation EU 2019/6. UK businesses must understand this roadmap to prepare for their upcoming requirements, which involve aligning with EU standards after Brexit.
The Deadline: July 16, 2026
The period of shared GMP regulations for human and veterinary medicines ends in mid-2026. From that point, veterinary medicinal products (VMPs) must fully comply with the new veterinary-specific requirements. The companies that still follow Volume 4 guidelines need to begin their process by finding existing deficiencies and making required improvements. Organisations must conduct early assessments together with updates to achieve compliance while sustaining product quality and meeting the July 2026 regulatory deadline.
From Volume 4 Compliance to 2025/2091 Requirements
The current GMP framework provides strong foundational support to the existing system, but Regulation (EU) 2025/2091 creates specific veterinary requirements which impact both Annex 1 & 2 Veterinary. Companies must assess their operations, identify gaps, and update standard operating procedures to comply with these new Veterinary GMP roadmap standards.
The organisation needs to establish processes which ensure that all manufacturing activities, quality control measures, and documentation practices will comply with the elevated requirements for protecting product quality and meeting regulatory requirements before the July 2026 deadline.
Contractual Updates Between MAHs and Third-Party Manufacturers
The main transformation organisations experience happens when they change their contracts with external manufacturing partners. Regulation (EU) 2025/2091 mandates formal contracts that clearly define responsibilities for quality management, reporting, and compliance obligations. Marketing Authorisation Holders (MAHs) must ensure that all suppliers understand the new veterinary GMP requirements and that agreements are revised well in advance of the July 2026 deadline. The process of proactively updating contracts brings multiple benefits, which include maintaining compliance with regulations, protecting product quality, and preventing both operational and legal risks.
Conclusion
UK-based manufacturers and MAHs must begin their work on Regulation (EU) 2025/2091 because it has become a mandatory requirement. Companies can achieve market access after July 2026 by assessing their current Good Manufacturing Practice (GMP) methods and updating their contracts while fulfilling veterinary-specific needs.
FAQs
- Does this regulation apply to existing products?
In fact, all veterinary procedures now used in the EU, which were authorised prior to the entry into force of the 2023 Regulation, would instead be valid for a period of five years post the 2026 deadline. - Can I still use the same facility for human and veterinary drugs?
The establishment needs to fulfil all of its required veterinary needs before it will become operational. Segregation, documentation, and quality systems require modifications to achieve compliance with Annexes 1 and 2. - What happens if we miss the July 2026 deadline?
Non-compliance will lead to two specific outcomes, which include suspension of manufacturing authorisation, product supply delays and regulatory penalties. The organisation needs to take immediate action because any delays will disrupt its operational activities.
