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Following the adoption of Regulation (EU) 2019/6 by the European Parliament and the Council of the European Union in December 2018, which saw the replacement of legislation such as Directive 2001/82/EC, there have been several hints pointing toward an overhaul of the current unified GMP framework. While the shift toward separate, veterinary-specific GMP requirements might seem disruptive, it is important to consider that although human and veterinary medicines have been covered under one regulatory framework for years, they are not the same and require separate approaches to meet the unique demands and challenges of their respective industries. Recognising the fragmentation, uniqueness and current challenges of the veterinary industry after the adoption of the regulation, it was only a matter of time until the European Commission stepped in to modernize the sector's GMP framework to strengthen its regulatory response and address animal health, safety and welfare concerns.
With Regulations (EU) 2025/2091 and 2025/2154 on the horizon, it is evident that Europe is now prepared to fully transition from veterinary GMP as a guideline framework to veterinary GMP as a binding legal instrument. This means these regulations, which will come into effect in July 2026, will be directly embedded into EU law, making compliance with these GMP requirements legally mandatory.
This strategic regulatory shift does more than just acknowledge the significance of veterinary medicinal products in public and animal health, it also aligns the EU’s approach to veterinary medicinal products with the One Health framework, making it essential in addressing shared human-animal health concerns such as antimicrobial resistance.
EudraLex Volume 4's Unified GMP Approach Limitations and Why Veterinary Manufacturing Needed a Clearer Path
There is no doubt that the pharma and veterinary industries manufacture distinct medicinal products that cater to different species with unique biological characteristics and needs. Unlike pharmaceutical products for humans, veterinary medicinal products must factor in additional complexities found in animals including but not limited to species-specific dosing. When we put all this into consideration and scrutinize the current unified GMP approach, it only makes sense to shift toward a separate, veterinary-specific regulatory framework. Although EudraLex Volume 4 is a solid guideline that has been the foundation of GMP expectations for decades, its status as a guidance framework rather than a binding regulation means its effectiveness in today's regulatory landscape is limited, particularly when addressing the specific needs and complexities of veterinary medicinal products. The growing concerns around antimicrobial resistance and zoonotic disease risks in addition to the environmental impact of veterinary medicines among other issues have exposed the cracks in EudraLex Volume 4 and highlighted its limitations in supporting the veterinary industry's evolving needs.
What Will Change When Commission Implementing Regulations (EU) 2025/2091 and 2025/2154 Take Effect in 2026
From 16 July 2026, manufacturers of veterinary medicinal products will be required to comply with Commission Implementing Regulations (EU) 2025/2091 and 2025/2154 once they take effect, marking a clear shift from the guideline-based approach the industry had become accustomed to. The new legally binding GMP framework, which will replace EudraLex Volume 4, will affect more than just veterinary product manufacturers. Every active substance producer, contract partner, importer, marketing authorisation holder, qualified person and national authority must now expect stricter compliance obligations as they will be held under the same GMP expectations.
Veterinary GMP Under Regulation (EU) 2025/2091
As a stakeholder in the veterinary industry, what you will easily notice when assessing Implementing Regulation (EU) 2025/2091 is the change of language when it comes to regulatory obligations. As a regulatory framework that is aligned with Regulation (EU) 2019/6, Regulation (EU) 2025/2091 replaces flexible and interpretive wording in its predecessor and instead uses direct and clear terms such as "must" and "shall". The regulation also goes a step further and introduces a comprehensive Pharmaceutical Quality System that covers the entire lifecycle of veterinary products with more focus on risk management, constant improvement and regulatory compliance.
Under the new framework, responsibilities are now clearly defined for all personnel including for outsourced activities and self-inspections. While some might argue that the structure still mirrors aspects of human GMP guidelines, manufacturers need to approach it as a separate regulation and must not confuse the two, especially organizations that produce both human and veterinary medicines. Manufacturers must now therefore juggle two different regulatory systems when catering to both markets to remain compliant and keep up with regulatory updates.
One of the new challenges companies that manufacture veterinary medicinal products will face after July 16, 2026 is gaining approval prior to changing specifications or processes. This approval, which adds stricter requirements for change control, is not required for predefined variations. Regulation (EU) 2025/2091 also comes with specific annexes which cover everything from sterile and biological products to specialized forms, computer systems, validation and site master files.
Unlike current GMP guidelines, starting July 2026, veterinary companies that outsource their manufacturing will now be expected to take up more responsibilities than before. This means that even if your manufacturing is handled by a third party, you still remain responsible for making sure GMP standards are met. Key issues such as accuracy, traceability, preventing cross contamination and having qualified personnel to approve batch releases are also among the quality safeguards given greater emphasis in Regulation (EU) 2025/2091.
How to Future-Proof Your Veterinary Medicinal Business Operations for Commission Implementing Regulations (EU) 2025/2091 and 2025/2154
Transitioning from the unified GMP approach the industry has relied on for years will present challenges that veterinary medicinal product manufacturers and other industry stakeholders must navigate and prepare for by July 2026. Before the new regulations are enforced, your organization must conduct a gap analysis against the EU Commission's correspondence tables to identify and address key areas where changes are necessary. In addition to this, it is essential to ensure your Pharmaceutical Quality System is upgraded and fully aligned with incoming regulatory demands. Implementing staff training early on and ensuring all personnel are aware of the shift from recommendation to obligatory is one of the best investments you can make at this stage to avoid costly human errors post enforcement. As PQE Group, we are aware of the hurdles regulatory updates cause for life sciences organizations, and that is why we have made it our mission to assist life sciences businesses, including veterinary pharma manufacturers, with our expert-backed quality services.
