- Article
Veterinary GMP in Europe: New Dedicated Framework & VICH GL60 Guide
- 15 Minutes
From 16 July 2026, veterinary medicinal products in the European Union will be governed by a dedicated and legally binding GMP framework, fully separate from human medicines regulation. This milestone driven by Regulation (EU) 2019/6, marks the first time both finished veterinary products and their active substances (APIs) follow their own enforceable regulatory system.This article explains what is changing, why it matters and how manufacturers, Marketing Authorisation Holders (MAHs) and API suppliers can adapt effectively.
Why Veterinary GMP Is Changing in 2026
The change is driven by Regulation (EU) 2019/6, which required the European Commission to establish a dedicated GMP framework for veterinary medicinal products. Until now, veterinary products have relied on the same GMP rules as human medicines, primarily EudraLex Volume 4 (Parts I and II, based on ICH Q7). That shared framework, while robust, was never designed with veterinary-specific factors in mind.From July 2026, EudraLex Volume 4 will no longer apply to veterinary products. The sector moves to two new, purpose-built regulations that reflect the realities of veterinary manufacturing.
From Human to Veterinary GMP: Why the Separation Matters
What does Regulation (EU) 2025/2091 cover?
Historically, veterinary medicinal products shared the same GMP framework as human medicines, primarily EU GMP Part I and Part II, based on ICH Q7. While this provided a robust baseline, it did not fully account for veterinary-specific factors:
- Multiple animal species with different pharmacokinetic profiles and dosing requirements
- Diverse routes of administration and formulation types not found in human medicines
- Unique supply chain structures that span global API sourcing and multi-species batch production
- Distinct contamination control requirements arising from cross-species manufacturing
The introduction of a dedicated framework is not a relaxation of standards but a clarification that ensures GMP expectations are appropriately tailored to veterinary realities. It also raises the bar significantly: what was previously guideline-based becomes enforceable law.
What Are the New Veterinary GMP Regulations?
Regulation (EU) 2025/2091 - Finished Veterinary Medicinal Products
This regulation replaces the previous reliance on Volume 4 for finished veterinary products. It establishes a fully independent, legally binding GMP framework applicable directly across all EU Member States. Technical content remains largely aligned with Volume 4, but requirements are now explicit, prescriptive and enforceable.
Regulation (EU) 2025/2154 + VICH GL60 - Veterinary APIs
VICH GL60 is the first harmonised GMP guideline specifically for veterinary active pharmaceutical ingredients (APIs). It maintains alignment with ICH Q7 while adapting requirements to veterinary realities, and is implemented in the EU through Regulation (EU) 2025/2154.
Key Differences vs EU GMP Part II: What Changes in Practice
- Quality Management: Core GMP principles remain unchanged. The independence of the Quality Unit is maintained and product quality review continues to be required. However, VICH GL60 introduces clearer expectations around responsibilities, documentation of investigations and batch linkage.
- Documentation and Data Integrity: Data integrity expectations are more explicit under the new framework. Electronic signatures must be secure and authenticated. Batch record review prior to release must include OOS investigations, deviations and related reports. Impurity profiles must be established for each API, with certain exceptions relevant to veterinary materials.
- Facilities and Contamination Control: Greater emphasis is placed on contamination control strategies. Dedicated areas are required for highly sensitising materials unless validated cleaning procedures are in place. Companies must apply formal quality risk management approaches when using shared facilities.
- Validation, Change Control and Supply Chain Communication: Prospective validation remains the preferred method. VICH GL60 reinforces structured change control processes, including formal classification of changes and evaluation of their impact on quality and stability. Crucially, there is an explicit requirement for communication across the supply chain, particularly between API and finished-product manufacturers.
- Supplier Qualification and Supply Chain Oversight: The supply chain becomes a focal point of regulatory attention. VICH GL60 introduces more prescriptive expectations for supplier qualification, including minimum testing before reducing controls and periodic verification of certificate of analysis reliability. Documentation and traceability requirements are significantly strengthened.
| Product Type | Applicable Framework from July 2026 |
|---|---|
| Finished veterinary medicinal product | Regulation (EU) 2025/2091 |
| Veterinary API | Regulation (EU) 2025/2154 + VICH GL60 |
| Human medicinal product | Continues under EudraLex Volume 4 |
Governance: The Most Significant Organisational Impact
The most significant impact of the new veterinary GMP framework is not technical, it is organisational. The role of the MAH becomes more central, with increased responsibility for oversight of manufacturing activities and supply chains.Quality agreements become critical tools to define responsibilities and ensure compliance across multiple parties. Regulators are expected to place greater emphasis on governance during inspections, focusing on how companies demonstrate control, traceability and accountability throughout the product lifecycle.
Practical Takeaways: How to Prepare for July 2026
The transition timeline is short. Companies that have not yet begun their gap assessment should prioritise the following actions:
| Priority Action | Focus Area |
|---|---|
| Conduct a gap assessment | VICH GL60 and Regulation (EU) 2025/2091 vs current quality systems |
| Update quality agreements | Define responsibilities clearly across all supply chain parties |
| Review data integrity systems | Ensure batch documentation and electronic records meet explicit requirements |
| Strengthen change control | Formalise classification and cross-party communication processes |
| Prepare for inspections | Build evidence of governance, traceability and accountability |
Evolution, Not Revolution
The transition to a dedicated veterinary GMP framework represents an evolution rather than a revolution. GMP principles remain consistent, but their application becomes more structured, transparent and adapted to the veterinary context.From July 2026, EudraLex Volume 4 will no longer apply to veterinary products. It is replaced by Regulation (EU) 2025/2091 for finished products and Regulation (EU) 2025/2154 + VICH GL60 for APIs. While GMP requirements remain technically similar, they are now legally much more stringent, binding regulation, not guidance.Companies that proactively align their systems, governance models and supply chain oversight with the new requirements will not only achieve compliance but also strengthen their operational robustness and regulatory credibility.
How Rephine Supports the Veterinary GMP Transition
Rephine combines regulatory expertise with practical implementation experience to support companies navigating this transition.
Our services include:
- Gap assessments against VICH GL60 and EU veterinary GMP requirements
- Supplier qualification strategies and audit readiness programmes
- Quality system optimisation and quality agreement review
- Alignment of organisational responsibilities with the new regulatory expectations
Contact Rephine to turn regulatory change into a strategic opportunity.
Frequently Asked Questions (FAQ)
What is VICH GL60?
VICH GL60 is the first harmonised GMP guideline specifically for veterinary active pharmaceutical ingredients (APIs). It maintains alignment with ICH Q7 while adapting requirements to veterinary-specific factors such as multiple animal species and diverse supply chain structures.
Is EudraLex Volume 4 still applicable to veterinary products after July 2026?
No. From 16 July 2026, EudraLex Volume 4 will no longer apply to veterinary medicinal products. Finished veterinary products will be governed by Regulation (EU) 2025/2091, and veterinary APIs by Regulation (EU) 2025/2154 in conjunction with VICH GL60.
What does Regulation (EU) 2025/2091 cover?
Regulation (EU) 2025/2091 sets out legally binding GMP requirements for finished veterinary medicinal products. It applies directly across all EU Member States and transforms previously guideline-based expectations into enforceable obligations.
What are the main new obligations for Marketing Authorisation Holders (MAHs)?
MAHs face increased responsibility for oversight of manufacturing activities and supply chains. Quality agreements must be more robust, and MAHs are expected to demonstrate governance, traceability and accountability throughout the product lifecycle under the new regulatory framework.
When does the new veterinary GMP framework come into force?
The new dedicated veterinary GMP framework, including Regulation (EU) 2025/2091 and Regulation (EU) 2025/2154 + VICH GL60, applies from 16 July 2026 across the European Union.
Mireya Rivera
Validation & GMP Consultant
About the Author:
Mireya Rivera is one of us Validation and GMP Consultant at Rephine, a global leader in GxP compliance and quality assurance.
We don’t just deliver audits or consultancy services, we partner with clients at every stage of their quality journey, offering end-to-end solutions that empower confidence and compliance.
With over 25 years of experience, Rephine has built an enviable reputation as the gold standard in the industry operating from four primary locations: Stevenage in the UK, Barcelona in Spain, India, and Shanghai in China.
She is committed to helping pharmaceutical, biotech, and medical device companies achieve the highest standards in manufacturing and supply chain integrity.
