Veterinary GMP from 16 July 2026: an operational checklist for transition to the new EU regulations

Commission Implementing Regulations (EU) 2025/2091 and (EU) 2025/2154 have applied since 16 July 2026. They establish dedicated GMP requirements, respectively, for veterinary medicinal products and for active substances used as starting materials in veterinary medicinal products. The immediate challenge is not to rebuild a mature quality system merely because its legal reference has changed. It is to demonstrate, clearly and consistently, that the pharmaceutical quality system (PQS), responsibilities and controlled documentation now reflect the applicable veterinary framework.

The European Commission states that, notwithstanding the different legal bases, veterinary GMP requirements and those for human medicinal products and active substances are aligned. Its official correspondence tables are therefore a practical starting point: they map the new provisions to the relevant former legislation and EudraLex Volume 4 material. They should support a structured impact assessment, not replace it.

Regulatory fact: Regulations (EU) 2025/2091 and 2025/2154 have applied from 16 July 2026. Practical GuideGxP recommendation: manage the change through one formally approved transition programme, with an accountable owner, a documented scope and auditable evidence of completion.

What changed — and what should not be assumed

For finished veterinary medicinal products, Regulation (EU) 2025/2091 provides a dedicated GMP rule set under Regulation (EU) 2019/6. Its structure includes requirements for the role of the marketing authorisation holder (MAH), the PQS, product quality reviews, self-inspection, management review, personnel, documentation, data integrity, production, quality control, Qualified Persons (QPs), certification and batch release, outsourced activities, quality defects and recalls.

For veterinary active substances, Regulation (EU) 2025/2154 provides a dedicated framework covering, among other matters, the starting point of manufacture, quality management, personnel, premises and equipment, documentation, materials, production, laboratory controls, validation, change control, complaints and recalls, outsourced activities, traceability and certain cell-culture or fermentation operations.

Alignment with the human GMP corpus does not mean that internal references can remain generic or that every human-medicinal-product annex applies automatically to every veterinary operation. The correspondence tables identify the relevant relationships, including specific veterinary annexes and areas presented as new in the finished-product regulation. Each site should determine applicability to its products, dosage forms, technologies, outsourced activities and supply chain.

The 30-day transition objective

The goal is a controlled, risk-based demonstration that the organisation has identified applicable provisions, updated the legal and procedural framework, assigned responsibilities and trained affected personnel. The following checklist is designed for senior QA leaders, QPs, heads of production and QC, MAHs, and veterinary active-substance manufacturers.

Operational checklist

1. Establish scope and regulatory applicability

• Separate the assessment for finished veterinary medicinal products under Regulation (EU) 2025/2091 from the assessment for veterinary active substances under Regulation (EU) 2025/2154. A site may fall within one or both regimes.
• Build an article-and-annex applicability matrix using the relevant Commission correspondence table. Record whether each provision is applicable, not applicable, already met, partially met or requires remediation.
• Include all legal entities and GxP interfaces: manufacturing sites, contract manufacturers, contract laboratories, import operations, warehouses where relevant, MAHs and active-substance suppliers.
• Identify product- and technology-specific elements. For finished products, this may include sterile manufacture, immunological veterinary medicinal products, ionising radiation and import or repackaging activities. For active substances, consider the stated starting point of manufacture and, where relevant, cell-culture or fermentation provisions.

GuideGxP recommendation: give every “not applicable” conclusion a rationale and named approver. Unsupported non-applicability statements are difficult to defend during inspection or partner due diligence.

2. Update the PQS and senior-management oversight

• Update the quality manual, PQS description, site master file where applicable, regulatory intelligence procedure and compliance register to identify the relevant 2025 regulation.
• Confirm that quality governance addresses the elements explicitly structured in the regulations: product quality reviews and management review for finished products; quality reviews and quality-management responsibilities for active substances.
• Review quality objectives and management-review inputs to ensure that implementation status, significant gaps, CAPAs, supplier impacts and outsourced-activity risks are visible to senior management.
• Assess whether existing quality-risk-management processes adequately justify prioritisation. Keep the legal transition itself under change control, even where the technical control remains unchanged.

3. Reconcile roles, responsibilities and quality agreements

Regulation (EU) 2025/2091 expressly addresses the MAH’s GMP role, as well as the QP, certification and batch release. The correspondence table identifies the MAH provision as new, drawing on established GMP concepts. This is a priority interface: MAH, manufacturer and QP responsibilities must be coherent in practice and in writing.

• Review organisation charts, job descriptions, delegations and training curricula for QA, QC, production, engineering, supply chain, regulatory affairs, the MAH and the QP.
• Verify that quality agreements clearly allocate oversight, change notification, deviation escalation, quality-defect handling, recall support, product-quality-review inputs and record availability.
• For active-substance operations, confirm the defined responsibilities of the quality and production units, including independence and decision-making routes where required by the site’s system.
• Test one realistic escalation scenario: a material discrepancy, a significant deviation or a quality defect. Confirm who decides, who informs the MAH, who assesses batch impact and who retains the evidence.

4. Perform a targeted documentation and data-integrity sweep

Documentation is not a cosmetic workstream. Regulation (EU) 2025/2091 separately addresses the documentation system, specifications and instructions, records, other documentation, retention periods and data integrity. Regulation (EU) 2025/2154 likewise contains discrete documentation, record and computerised-system requirements.

• Search controlled templates, SOPs, protocols, reports, specifications, master instructions, batch records, laboratory records, validation documents, audit checklists and training modules for obsolete or incomplete legal references.
• Prioritise documents that determine GMP decisions: batch documentation, deviation and OOS procedures, change control, product quality review, supplier qualification, quality agreements, recall procedures and QP certification processes.
• Confirm that procedures distinguish original data, review, correction, approval, retention and retrieval controls. For computerised systems, assess whether procedural references, roles and validation documentation still describe actual use.
• Do not revise documents solely to change a citation. Where the new regulatory structure makes an accountability or control expectation more explicit, assess and record the operational impact.

5. Reconfirm supplier qualification and outsourced activities

The finished-product regulation contains specific provisions on supplier qualification and compliance with specifications, as well as outsourced activities. The active-substance regulation covers outsourced activities, traceability and transfer of information. These are high-value areas for a focused review because regulatory change can expose mismatches between technical agreements and actual supply-chain practice.

• Reconcile approved-supplier lists, supplier risk classifications, technical agreements, audit status and material specifications.
• Confirm that contracts define change notification, access to records, subcontracting controls, deviation notification, complaint and recall collaboration, data ownership and retention expectations.
• For active substances and intermediates, verify traceability arrangements across manufacture, testing, storage, distribution and information transfer.
• Document whether existing supplier controls remain adequate against the mapped articles; raise CAPAs where the evidence is fragmented or contractual allocation is unclear.

6. Test release, quality-defect and recall readiness

For finished veterinary medicinal products, the regulation separately addresses QP responsibilities, certification and batch release, imports, unplanned deviations, quality defects and product recalls. A transition review should therefore include an end-to-end batch disposition exercise rather than a paper-only reference update.

1. Select a representative recent batch, preferably involving a deviation, external laboratory, imported component or other meaningful interface.
2. Trace the evidence from material receipt through manufacturing, testing, deviation assessment, batch-record review, certification and release.
3. Verify that QP access to relevant information, MAH communication and decision records are demonstrable.
4. Run a desk-based quality-defect or recall simulation to test contacts, decision authority, traceability, product-status control and documentation retrieval.

A practical 30-day sequence

Close the transition with evidence, not assertions

A credible transition file should show more than a statement that the site “follows EudraLex”. It should demonstrate how the organisation used the Commission’s official mapping, determined applicability, updated the governing framework and verified operational control. Retain the approved impact assessment, document inventory, training records, revised agreements, test results, CAPAs and management-review output in one retrievable package.

The soundest position is balanced: the 2025 regulations create the veterinary legal basis now in application, while the Commission’s correspondence material shows substantial technical alignment with the established human GMP material. Treat this as a disciplined regulatory change programme — not an opportunity either to dismiss the change as purely administrative or to create unnecessary GMP work with no risk or applicability rationale.

Official sources

• European Commission — EudraLex Volume 4: Good Manufacturing Practice guidelines
• Commission Implementing Regulation (EU) 2025/2091
• Commission Implementing Regulation (EU) 2025/2154
• European Commission — table of correspondence for veterinary medicinal products
• European Commission — table of correspondence for veterinary active substances