The introduction of the new EU Veterinary GMP framework represents a significant regulatory change for manufacturers of veterinary medicinal products. Since 16 July 2026, dedicated Good Manufacturing Practice (GMP) requirements for veterinary medicinal products and veterinary active substances have applied under Commission Implementing Regulations (EU) 2025/2091 and (EU) 2025/2154, adopted pursuant to Regulation (EU) 2019/6. Although the core GMP principles remain largely consistent with established EU GMP requirements, manufacturers must ensure that their Pharmaceutical Quality System (PQS), documentation and quality oversight comply with the new Veterinary GMP specific legal framework, making GMP consulting an increasingly valuable resource for companies navigating the transition.

Failure to implement these changes may result in inspection observations, delays in batch certification and increased regulatory scrutiny. Many organisations assume that because the GMP principles are largely unchanged, no immediate action is required. In reality, the transition requires a structured review of quality systems, governance and documentation to demonstrate compliance with the applicable implementing regulations.

The good news is that companies do not have to navigate these changes alone. With the right regulatory strategy and GMP expertise, the transition can become an opportunity to strengthen quality systems, improve inspection readiness and build long-term compliance. In this guide, we explain what has changed, what manufacturers should prioritise, and how Billev Pharma East helps organisations implement the new Veterinary GMP requirements efficiently and confidently.

What is the new Veterinary GMP framework?

The new Veterinary GMP framework establishes dedicated EU Good Manufacturing Practice requirements for veterinary medicinal products and active substances used as starting materials for veterinary medicinal products. Since 16 July 2026, compliance has been governed by Commission Implementing Regulations (EU) 2025/2091 and (EU) 2025/2154, which supplement Regulation (EU) 2019/6. Manufacturers should review their Pharmaceutical Quality System (PQS), GMP documentation, supplier qualification processes and inspection readiness to ensure compliance with the new regulatory framework.

What has changed under the new veterinary GMP framework?

The new Veterinary GMP framework introduces a dedicated legal basis for Good Manufacturing Practice applicable to veterinary medicinal products and active substances used in veterinary medicines within the European Union. Since 16 July 2026, manufacturers are no longer required to rely on EudraLex Volume 4 as the primary legal basis for veterinary GMP. Instead, compliance is governed by two dedicated legal acts: Commission Implementing Regulations (EU) 2025/2091 and (EU) 2025/2154, adopted under Regulation (EU) 2019/6.

The regulatory principles remain closely aligned with those applied to human medicinal products; however, the veterinary sector is now supported by legislation specifically developed for veterinary medicinal products. This provides greater legal certainty while requiring manufacturers to ensure that their Pharmaceutical Quality System (PQS), documentation, outsourced activities and quality oversight are fully aligned with the new regulatory requirements.

The changes affect every stage of the manufacture, including quality management, production, supplier qualification, outsourced activities, documentation and inspection readiness. Rather than being viewed solely as a legislative update, implementation of the new framework should be integrated into continuous improvement of the pharmaceutical quality system.

Who needs to comply with the new veterinary GMP requirements?

Many companies assume that the new Veterinary GMP framework only affects finished product manufacturers. In reality, the scope is much broader. The implementing regulations apply to all organisations, involved in the manufacture, import and quality oversight of veterinary medicinal products, including manufacturers of active pharmaceutical ingredients (APIs), contract manufacturers, quality control laboratories and businesses performing outsourced GMP activities.

Marketing Authorisation Holders (MAHs) also retain significant responsibilities under Regulation (EU) 2019/6, particularly regarding oversight of outsourced activities and the maintenance of appropriate quality agreements. Manufacturers and MAHs should clearly define responsibilities, ensure effective quality oversight and apply a risk-based approach to supplier qualification and ongoing supplier management.

For many organisations, compliance will require collaboration across Quality Assurance, Regulatory Affairs, Production and Supply Chain teams. Early cross-functional planning helps minimise implementation risks and ensures a smooth transition to the new framework.

What do manufacturers need to do to comply with the New Veterinary GMP framework?

Compliance with the new Veterinary GMP framework requires more than updating regulatory references. Manufacturers need to demonstrate that their Pharmaceutical Quality System (PQS), documentation and operational processes comply with the requirements of Commission Implementing Regulations (EU) 2025/2091 and (EU) 2025/2154.

The first step should be a comprehensive gap assessment of the existing Pharmaceutical Quality System. Organisations should evaluate whether quality policies, responsibilities, quality risk management processes and management oversight remain compliant with the new legislative requirements. The implementing regulations reinforce the importance of a documented, risk-based Pharmaceutical Quality System that is effectively maintained, monitored and continuously improved, making QMS consulting an effective way to identify compliance gaps.

Next, manufacturers should review and update all GMP documentation, including Standard Operating Procedures (SOPs), Quality Manuals, validation documentation, technical agreements, change control procedures and regulatory references. The new regulation requires documentation to remain current, unambiguous and capable of demonstrating compliance throughout the product lifecycle.

Supplier qualification and outsourced activities should be reassessed using a documented, risk-based approach. Manufacturers should verify that suppliers remain appropriately qualified, quality agreements are current, outsourced activities are adequately controlled and supplier performance is routinely monitored through audits and periodic review.

Finally, organisations should strengthen their inspection readiness. Internal GMP audits, Product Quality Reviews (PQRs), Qualified Person (QP) oversight and staff training help identify compliance gaps before regulatory inspections occur. Proactive preparation reduces regulatory risk and ensures manufacturers can confidently demonstrate compliance with the new Veterinary GMP requirements.

Veterinary GMP compliance checklist

• Review Pharmaceutical Quality System (PQS)
• Perform a GMP gap assessment
• Update SOPs and the Quality Manual
• Review Technical and Quality Agreements
• Reassess supplier qualification using a risk-based approach
• Review oversight of outsourced activities
• Conduct Internal GMP Audits
• Train relevant personnel
• Strengthen inspection readiness

Why choose Billev Pharma East for your veterinary GMP transition?

Implementing the new Veterinary GMP framework requires more than updating documentation. Manufacturers must interpret and apply new regulatory requirements, assess their impact on existing quality systems and demonstrate compliance during inspections. Without appropriate regulatory expertise, organisations may face unnecessary compliance risks, delays and increased inspection findings. This is where Billev Pharma East becomes your strategic compliance partner.

Our team supports veterinary medicinal product manufacturers throughout the entire transition process. We begin with a comprehensive GMP gap assessment to identify areas that require improvement, followed by practical recommendations tailored to your organisation. We help review and update your Pharmaceutical Quality System (PQS), revise SOPs and Quality Manuals, strengthen change control processes and ensure your documentation reflects the new legal framework.

Beyond documentation, we help organisations strengthen inspection readiness through internal GMP audits, mock inspections, supplier audits and vendor qualification activities. We also support the review of technical and quality agreements and the oversight of outsourced activities to ensure compliance with current Veterinary GMP requirements.

What sets Billev Pharma East apart is our integrated approach. Instead of working with multiple service providers, you gain access to one multidisciplinary team covering GMP & Qualified Person (QP) consultancy, Veterinary Regulatory Affairs, Quality Assurance, Pharmacovigilance and regulatory documentation. With extensive experience working across EU regulatory frameworks and supporting interactions with national competent authorities and the EMA, we help transform complex regulatory requirements into practical, business-focused solutions.

Whether you need support with a specific compliance project or a long-term quality partner, Billev Pharma East provides the expertise, regulatory insight and hands-on implementation needed to achieve sustainable Veterinary GMP compliance with confidence.

What is most important when preparing for the New Veterinary GMP requirements?

Successful implementation of the new Veterinary GMP framework starts long before the first regulatory inspection. The biggest mistake manufacturers can make is treating the new regulations as a simple documentation exercise. Instead, companies should adopt a structured, risk-based approach that evaluates how the new legal framework impacts their quality system, manufacturing operations and supplier oversight. The Pharmaceutical Quality System (PQS) should serve as the foundation for all compliance activities, ensuring that quality, risk management and continuous improvement are embedded across the organisation.

A key priority is identifying compliance gaps within existing quality systems. This includes reviewing Quality Manuals, Standard Operating Procedures (SOPs), technical and quality agreements, validation documentation, change control procedures and other controlled documents to ensure they reflect the current legal framework. Manufacturers should also verify that supplier qualification programmes remain effective, responsibilities are clearly documented and quality agreements are up to date. These activities help demonstrate that GMP compliance is maintained throughout the entire supply chain.

Inspection readiness should become an integral part of routine quality management. Regular internal audits, management reviews, staff training and documented CAPA activities help organisations identify weaknesses before inspectors do. A proactive approach not only reduces regulatory risk but also improves operational efficiency and strengthens confidence in the quality system.

Ultimately, preparing for the new Veterinary GMP requirements is about building a sustainable compliance culture. Companies that invest early in robust quality systems, clear documentation and continuous improvement will be better positioned to meet regulatory expectations, minimise business disruption and maintain uninterrupted market access under the new EU framework.

Why should companies start preparing for veterinary GMP now?

Although the new Veterinary GMP requirements are already in force, achieving full compliance requires careful planning, adequate resources and cross-functional coordination. Delaying implementation may increase the risk of compliance gaps, inspection findings and operational disruption, whereas early preparation enables organisations to implement changes in a structured and efficient manner while maintaining business continuity.

One of the most time-consuming activities is reviewing and updating the Pharmaceutical Quality System (PQS). Quality Manuals, Standard Operating Procedures (SOPs), technical agreements, validation documentation and regulatory references all need to be assessed to ensure they reflect the new legal framework. Because these documents are interconnected, even small updates often require multiple reviews, approvals and staff training before implementation. The new regulation also places significant emphasis on maintaining an effective documentation system and ensuring that only current, approved documents are in use.

Supplier qualification and oversight of outsourced activities should also be reviewed. Manufacturers are expected to apply a documented, risk-based approach to supplier qualification, maintain appropriate qualification records and ensure that outsourced activities are governed by current quality agreements. Depending on the complexity of the supply chain, supplier qualification activities, audits and contractual updates may require significant time to complete.

Finally, companies should remember that regulatory inspections will assess not only whether documentation has been updated, but also whether the new Veterinary GMP requirements have been effectively implemented in daily operations. Inspectors may review quality records, self-inspection programmes, CAPAs, supplier management and evidence that employees understand and consistently apply the revised procedures. Organisations that begin preparing early are therefore better positioned to reduce compliance risks, avoid costly corrective actions and demonstrate a mature, inspection-ready quality system from day one.

What are the biggest challenges companies face during the veterinary GMP transition?

One of the main challenges is determining the extent of changes required within the existing Pharmaceutical Quality System. Although the core GMP principles remain familiar, many organisations identify outdated regulatory references, incomplete quality agreements, insufficient supplier qualification records or deficiencies in quality oversight that require remediation.

Another common challenge is ensuring that every department understands its role in the transition. Quality Assurance, Regulatory Affairs, Production and Supply Chain teams must work together to maintain compliance across the entire product lifecycle. Without clear responsibilities and effective communication, implementation projects can become time-consuming and resource intensive.

Working with experienced Veterinary GMP specialists helps companies identify risks early, prioritise remediation activities and implement changes efficiently, reducing both compliance risks and operational disruption.

Are you ready for the new veterinary GMP framework?

The implementation of the new Veterinary GMP framework is more than a regulatory obligation—it is an opportunity to strengthen your Pharmaceutical Quality System (PQS), improve operational performance and establish a sustainable approach to regulatory compliance. Organisations that proactively review their quality systems, update GMP documentation and enhance inspection readiness will be better positioned to maintain uninterrupted manufacture, batch certification and market supply under the new legislative framework.

At Billev Pharma East, we combine expertise in Veterinary Regulatory Affairs, GMP & QP consultancy, quality systems, audits and supplier qualification to help manufacturers implement the new requirements with confidence. Rather than providing isolated services, we deliver practical, end-to-end support tailored to your organisation—from gap assessments and documentation updates to inspection readiness and long-term compliance strategies. Our multidisciplinary team works with EU regulatory authorities and EMA requirements every day, enabling us to translate complex legislation into efficient, business-focused solutions.

If you are preparing for the new Veterinary GMP requirements, now is the right time to act. Contact Billev Pharma East to discuss your compliance challenges and discover how our experts can help you achieve a smooth, efficient and inspection-ready transition to the new EU regulatory framework.

Frequently asked questions

Sources: 1 – Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products, 2 – Commission Implementing Regulation (EU) 2025/2091 laying down Good Manufacturing Practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6, 3 – Commission Implementing Regulation (EU) 2025/2154 laying down Good Manufacturing Practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6, 4 – European Commission – Tables of Correspondence between previous Veterinary GMP guidance and Commission Implementing Regulation (EU) 2025/2091.

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