Commission Implementing Regulation (EU) 2025/2091 and Commission Implementing Regulation (EU) 2025/2154 have applied from 16 July 2026. This is not a forthcoming revision of guidance: both Regulations are binding in their entirety and directly applicable in all EU Member States.
For veterinary medicinal product manufacturers, API manufacturers, marketing authorisation holders (MAHs), QPs and supply-chain partners, the practical GMP disciplines will look familiar. The European Commission states that the veterinary GMP requirements and those for their active substances are aligned with the requirements for medicinal products for human use and their active substances. The material change is the legal form: the relevant veterinary GMP requirements are set out in directly applicable implementing Regulations made under Regulation (EU) 2019/6.
What has changed in law
Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025 lays down GMP for veterinary medicinal products. Commission Implementing Regulation (EU) 2025/2154 of 17 October 2025 lays down GMP for active substances used as starting materials in veterinary medicinal products. Each entered into force after publication in the Official Journal and applies from 16 July 2026.
This distinction matters in inspection readiness, regulatory intelligence and quality-system governance. EudraLex Volume 4 remains an important reference point: its veterinary section presents the two Regulations and publishes tables of correspondence to the human-medicines GMP guidelines. However, for a veterinary activity within scope, compliance arguments should begin with the applicable provisions of the relevant Implementing Regulation rather than treating a corresponding human EU GMP chapter or Annex as the veterinary legal requirement itself.
Regulatory fact: the Commission’s correspondence tables are an overview of the relationship between the veterinary Regulations and GMP guidelines applicable to human medicinal products. They demonstrate alignment; they do not remove the need to assess the wording, scope and annexes of the applicable veterinary Regulation.
The two Regulations: assign ownership correctly
| Regulation | Primary regulated subject | Key operational consequence |
|---|---|---|
| Commission Implementing Regulation (EU) 2025/2091 | GMP for veterinary medicinal products | Product manufacturers should map their PQS, production, QC, certification, release, outsourced-activity and recall arrangements to the Regulation and its Annexes. |
| Commission Implementing Regulation (EU) 2025/2154 | GMP for active substances used as starting materials in veterinary medicinal products | API manufacturers and veterinary-product manufacturers should establish clearly where API GMP begins and ensure supplier oversight, technical documentation and quality agreements reflect the correct regulatory framework. |
Regulation (EU) 2025/2091 includes provisions on the MAH’s role regarding GMP, implementation and requirements of the pharmaceutical quality system, product quality reviews, self-inspection and management review. It also addresses personnel, premises, equipment, documentation, data integrity, production, supplier qualification, prevention of cross-contamination, QC, the QP, certification and batch release, imports, outsourced activities, quality defects and product recalls.
Its Annexes provide additional requirements for sterile veterinary medicinal products and aseptic manufacturing, biological and immunological veterinary medicinal products, and other specified manufacturing contexts. The Commission’s correspondence table explicitly maps these areas to the established EudraLex Volume 4 corpus, including Part I, Annex 1, Annex 2, Annex 11, Annex 15, Annex 16 and Annex 21 where relevant.
Regulation (EU) 2025/2154 applies to active substances used as starting materials in veterinary medicinal products. It specifies, among other matters, the relationship between API manufacture and sterile or biological requirements. The Regulation states that GMP for sterile active substances applies only up to the point immediately before the active substance is rendered sterile; sterilisation and aseptic processing are subject to the requirements in Annex I to Implementing Regulation (EU) 2025/2091. It also provides that biological active substances must meet the additional requirements in Annex II to Regulation (EU) 2025/2091, subject to stated exceptions.
Why multiproduct sites need a deliberate impact assessment
A site manufacturing both human and veterinary products may have long operated one integrated quality system. That remains operationally sensible where controls are shared, but it is no longer sufficient simply to cite human EU GMP documents as the legal basis for veterinary controls.
The highest-risk gaps are likely to arise where one process, system or supplier relationship serves several legal regimes. Examples include shared manufacturing suites, QC laboratories, warehouse and transport interfaces, contract laboratories, repackaging operations, importation activities, electronic quality-management systems and batch-certification workflows.
GuideGxP recommendation: create a regulation-to-process applicability matrix. For every veterinary product family, API and relevant service, identify the applicable legal requirement, the linked SOP or technical standard, the accountable process owner, the evidence of implementation and any relationship with the corresponding EudraLex Volume 4 expectation. This makes legal applicability visible without unnecessarily duplicating the operating model.
Shared facilities and cross-contamination
Prevention of cross-contamination is expressly addressed in Article 29 of Regulation (EU) 2025/2091. The Commission’s correspondence table links this Article with relevant provisions in EudraLex Volume 4 Part I, Chapter 3 and Chapter 5. For multiproduct sites, the question is therefore not whether established contamination-control practices remain valuable; they do. The question is whether the site can demonstrate that its facility design, campaign controls, cleaning approach, material and personnel flows, segregation decisions and risk assessments satisfy the directly applicable veterinary requirement for the products concerned.
GuideGxP recommendation: review the site contamination control strategy (CCS), or equivalent site-wide contamination-control governance, through a veterinary applicability lens. Record where a control is common across human and veterinary manufacture, and where the veterinary Regulation or its Annexes require a product-specific assessment.
Quality agreements: update the legal and operational architecture
Outsourced activities are expressly covered by Article 43 of Regulation (EU) 2025/2091. The Commission maps this provision to EudraLex Volume 4 Part I, Chapter 7. Supplier qualification is addressed separately in Article 28, while the API Regulation establishes the GMP framework for active substances used as veterinary starting materials.
Quality agreements should therefore do more than retain generic references to “EU GMP”. They should allocate responsibilities against the actual veterinary legal framework, especially where the parties support product manufacture, API manufacture, testing, importation, packaging, storage or certification and batch release.
Priority agreement checks
- Confirm whether the supplied material is an active substance used as a starting material in a veterinary medicinal product and whether Regulation (EU) 2025/2154 applies to the supplier activity.
- Identify the veterinary medicinal product activities governed by Regulation (EU) 2025/2091, including any relevant Annex requirements.
- Define ownership for change notification, deviations, OOS investigations, complaints, quality defects, recalls, audit access, records and data-integrity escalation.
- Ensure the agreement supports the MAH’s GMP role and the QP’s certification and batch-release responsibilities where applicable.
- Remove ambiguous wording that treats a human EU GMP reference as the sole legal basis for a veterinary obligation.
QP, QA and Regulatory Affairs: practical next steps
- Perform a portfolio scoping exercise. Identify all veterinary medicinal products, veterinary APIs, markets, sites, contract manufacturers, contract laboratories, importers and distribution interfaces affected from 16 July 2026.
- Map legal requirements to the PQS. Use the Regulations as the primary legal source; use the Commission correspondence tables to support efficient comparison with established EudraLex Volume 4 controls.
- Assess documentation. Review Site Master Files, quality manuals, product quality review procedures, validation policies, supplier-management procedures, batch documentation and QP certification arrangements for correct applicability statements.
- Review quality agreements and supplier files. Prioritise high-risk APIs, shared facilities and outsourced critical activities.
- Train the decision-makers. QA, QPs, Regulatory Affairs, procurement and supply-chain teams should understand that familiar technical GMP practice now sits within a distinct, directly applicable veterinary legal framework.
- Prepare an inspection narrative. Be able to explain how the site distinguishes regulatory requirements from internal standards and how it controls interfaces with human-medicines GMP operations.
Bottom line
The technical continuity with human EU GMP should make implementation manageable, particularly for mature organisations. It should not, however, obscure the compliance task. Since 16 July 2026, veterinary medicinal product GMP and veterinary API GMP are governed by two directly applicable EU Regulations: Commission Implementing Regulation (EU) 2025/2091 and Commission Implementing Regulation (EU) 2025/2154.
For senior quality leaders, the immediate objective is traceability: show which legal requirement applies, where it is implemented in the PQS and supply chain, who owns it, and what contemporaneous evidence demonstrates control. That is the most robust route to consistent compliance across veterinary-only and multiproduct operations.
