From 16 July 2026, the EU veterinary GMP frameworks will undergo a structural change as it moves from guidance-based expectations to directly applicable legislation. Two implementing regulations will replace the previous reliance of EudraLex Volume 4 for the veterinary section:
- One covering veterinary medicinal products (VMPs) and
- another addressing active substances.
Although many stakeholders already follow established GMP principles, the regulatory shift significantly increases the expectations for demonstrating compliance.
From guidance to legal framework
The introduction of these regulations establishes a dedicated legal basis for veterinary GMP, separate from the framework shared with human medicinal products. While the technical requirements remain largely aligned with the existing GMP principles, their legal nature changes fundamentally.
This transition affects not only terminology, but also compliance expectations:
- Flexibility in interpretation is replaced by clearly enforceable requirements.
- Guidance-based practices become legally binding obligations.
- Implicit understanding must now be supported by explicit documentation.
As a result, the focus shifts from applying GMP principles to demonstrating compliance in a consistent and traceable manner.
While being broadly aligned with existing GMP principles, the new veterinary GMP also introduces a more structured, veterinary-focused framework. It addresses the specific complexities of veterinary medicinal products, such as multi-species use and food chain considerations. Consolidation of previously fragmented requirements is specifically reflected in a new Annex III: Specific requirements for certain medicinal products.
Strengthened role of the MAH
The new framework reinforces the role of the MAH as a central actor responsible for ensuring product quality and regulatory compliance across the full lifecycle. This includes:
- maintaining alignment with the marketing authorisation,
- ensuring appropriate management of changes and variations,
- reviewing Product Quality Reviews (PQRs) and associated CAPA actions,
- overseeing the effectiveness of the Pharmaceutical Quality System (PQS).
Importantly, the expectations extend beyond oversight in principle. The MAH must be able to provide clear evidence of active involvement, particularly when activities are outsourced.
For many organisations, this may raise practical questions like:
- Are responsibilities between MAHs, manufacturers, importers and CMOs clearly defined?
- Is change control decision-making process clearly documented?
- How is cross-organisational CAPA management coordinated and verified?
- Can MAH oversight be demonstrated beyond formal review steps?
Arrangements that rely on informal practises or historical working models may no longer be sufficient.
Lifecycle thinking and integrated quality systems
Another important aspect emphasised by the new regulations is the integration of lifecycle management into the Pharmaceutical Quality System. Rather than treating quality elements as separate processes, the framework expects:
- A coherent system linking risk management, change control, CAPA and PQR.
- Continuous evaluation of product and process performance over time.
- Management involvement in reviewing quality trends and driving improvements.
This reinforces the need for organisations to move from a procedural approach towards more holistic and system-based view of quality management.
Documentation: from supporting role to critical evidence
Documentation becomes a critical factor in demonstrating compliance. In many cases organisations already perform the required activities, but documentation may not fully reflect actual practices.
A common example is the continued reference to EudraLex Volume 4 in SOPs, quality agreements or internal quality documents. From July 2026 onward, such references may no longer accurately describe the applicable regulatory framework for veterinary products. Even minor inconsistencies can raise questions during inspections, particularly when they create ambiguity regarding the legal basis of requirements. Ensuring that documentation in aligned, up to date and internally consistent, will therefore be essential.
Areas worth reviewing before mid-July 2026
While major quality system redesign is typically unnecessary, targeted review of certain areas is recommended:
- Are assumptions made that existing practices automatically meet the new legal requirements?
- Are there outdated regulatory references in SOPs and quality agreements?
- Are responsibilities across supply chain partners clearly defined, or are there overlaps or gaps?
- Are oversight activities performed but not sufficiently documents?
- Are there gaps between actual practices and how they are described in documentation.
The objective is to ensure that compliance is not only achieved, but clearly demonstrable.
Practical examples
Change control in outsourced manufacturing
When a contract manufacturer initiates a process change, the MAH must ensure that the impact on the marketing authorisation is properly evaluated. The process, decisions and approvals should be fully traceable.
Deviation and CAPA management
Although investigations may be carried out by the manufacturer, the MAH is expected to review conclusions critically and confirms that corrective and preventive actions are appropriate, effective and implemented.
Product Quality Review and trend evaluation
Recurring minor issues indicate underlying systemic risks. The MAH should actively assess such trends and determine whether broader corrective actions are required.
A Practical readiness-check
A useful way to assess your readiness is to ask yourself: If a regulatory inspection were conducted under the new framework today, could we clearly demonstrate:
- How are responsibilities allocated across the supply chain?
- How is compliance monitored and ensured in practice?
In many cases, the main gap(s) often lies in clarity, consistency and traceability rather the in the underlying processes.
Summary: From doing to demonstration
The transition to the new veterinary GMP regulations does not fundamentally alter established practices. Instead, it elevates expectation regarding how those practices are documented, justified and demonstrated. Organisations that ensure clear definition of responsibilities, alignment of documentation and visible oversight are better positioned for a smooth transition.
How Medfiles supports veterinary GMP compliance
At Medfiles, we support veterinary medicinal product companies with practical veterinary GMP and quality support throughout the product lifecycle. Our experts can help assess current quality systems, review quality documents, identify potential compliance gaps, and support preparations for the new veterinary GMP framework.
Whether you need a targeted gap assessment or broader regulatory and quality support, our team is happy to help. Reviewing documentation and responsibilities in advance may help ensure a smoother transition when the new framework applies.
Author: Eeva-Maija Walin, Senior Pharmaceutical Chemical Expert
Eeva-Maija Walin has worked at Medfiles since 2019 as a Senior Pharmaceutical Chemical (CMC) Expert. She holds an M.Sc. in Chemistry and has further broadened her expertise through studies in pharmacy and microbiology at open universities. Prior to joining Medfiles, Eeva-Maija worked for almost 20 years in various CMC expert roles within the pharmaceutical industry.
She has extensive experience in CMC documentation for new marketing authorisation applications and post-approval variations submitted to EU medicines authorities and the FDA. Her expertise includes preparation of quality summaries, evaluation of client documentation against regulatory requirements (gap analyses), and advising on GMP-related matters. At Medfiles, Eeva-Maija supports clients in a wide range of drug development and lifecycle management projects for both human and veterinary medicinal products, drawing on her strong background in pharmaceutical development, quality documentation and regulatory compliance.
