Veterinary GMP 2026: The new regulatory framework for veterinary medicines – What manufacturers and marketing authorisation holders need to know and implement strategically now!
The requirements placed on stakeholders in the animal health sector are constantly evolving, extending far beyond mere compliance with technical standards. Whether due to the increasing complexity of global supply chains, advances in scientific knowledge or the harmonisation of international markets, a sound understanding of the targeted implementation of regulatory requirements is now the decisive factor for market compliance and sustainable business success. The industry is currently facing a fundamental change to Good Manufacturing Practice for veterinary medicinal products, which will usher in a new phase of legal autonomy from 16 July 2026. In this article, you will learn about the far-reaching changes brought about by Implementing Regulations (EU) 2025/2091 and 2025/2154, how the role of the marketing authorisation holder will change in practice, and what strategic measures are required to ensure a legally compliant transition.
Just a few years ago, many companies in the veterinary sector viewed GMP requirements primarily as an extension of the rules applicable to human medicines, as set out in EudraLex Volume 4. This historically evolved structure meant that, from a regulatory perspective, the veterinary sector was often perceived as an annex to the human sector, which, whilst leading to a certain degree of consistency in day-to-day practice, also resulted in ambiguities regarding legal classification. Previous practice was based largely on guidelines which, whilst reflecting the state of the art, were often formulated in such a way that, due to their legal nature, they were treated as recommendations with a certain degree of interpretative leeway.
However, with the entry into force of Regulation (EU) 2019/6 on veterinary medicinal products, the foundations were laid for a comprehensive reorientation, the specific details of which are now being set out in the relevant implementing regulations.
This marks a fundamental paradigm shift. The previous approach, which was based on flexible guidelines, is now being replaced by a directly applicable and legally binding framework. Whilst the substantive requirements largely reflect the tried-and-tested principles of the EU GMP Guidelines, the formal separation ensures a clear distinction between the legal bases. For manufacturers and marketing authorisation holders, this means that they can no longer rely on the general interpretation of EudraLex Volume 4, but must instead refer to the specific provisions of the new regulations as the primary source of law.
The new pillars of Veterinary GMP: (EU) 2025/2091 and 2025/2154!
In future, the regulatory framework for the manufacture of veterinary medicinal products will be largely determined by two key implementing regulations, which were published on 27 October 2025 and will become mandatory from 16 July 2026. These regulations form the legal basis for the entire manufacturing process and cover both finished medicinal products and active substances.
| Regulation | Focus | Key features |
| (EU) 2025/2091 | Finished medicinal products | Establishment of GMP requirements for veterinary medicinal products, including nine specific annexes on topics such as sterile manufacturing, biological products and validation. |
| (EU) 2025/2154 | Active pharmaceutical ingredients (APIs) | Definition of GMP rules for active substances used as starting materials in the manufacture of veterinary medicinal products. |
A key feature of these new legal acts is the greater precision of their wording, which results in a significant increase in their legal binding force. Previous guidelines frequently used the auxiliary verb ‘should’, which was often interpreted in a regulatory context as a recommendation from which one could deviate in justified cases. In the new implementing regulations, this is consistently replaced by ‘shall’. This means that every requirement becomes a strict legal obligation, the non-compliance with which constitutes a direct breach of EU law. This linguistic nuance underscores the legislator’s intention to harmonise standards in the veterinary sector and to strengthen the enforceability of GMP rules.
Furthermore, Regulation (EU) 2025/2091 is characterised by a clearer structure and comprises a total of nine annexes, which specifically define requirements for different product groups and manufacturing processes.
Annex I, for example, sets out the requirements for aseptic manufacturing, whilst Annex IV specifies the requirements for computerised systems and Annex V deals with qualification and validation. The detailed nature of these annexes makes it essential to carefully review and adapt existing processes. Particularly noteworthy is Annex III, which for the first time brings together the requirements for herbal veterinary medicinal products, premixtures for medicated feed and medical gases. Previously, these regulations were scattered across various documents; they are now clearly and consistently consolidated.
Focus on Marketing Authorisation Holders: The redefinition of responsibility under Article 3!
One of the most significant changes introduced by Regulation (EU) 2025/2091 is found in Article 3, which clarifies the role of the marketing authorisation holder (MAH) and significantly expands their responsibilities within the manufacturing process. In the past, the prevailing view was often that responsibility for GMP compliance lay primarily with the manufacturer or contract manufacturer, whilst the MAH focused on the regulatory maintenance of the marketing authorisation. This separation is removed by the new legal framework.
The MAH is now explicitly required to perform an active control and coordination function. This includes, in particular:
- Ensuring compliance: The marketing authorisation holder must ensure that all manufacturing specifications and instructions correspond exactly to the information contained in the marketing authorisation documentation. Any changes to the marketing authorisation must be communicated to the manufacturer immediately and in a documented form.
- Evaluation of the Product Quality Review (PQR): Even if the MAH is not the manufacturer itself, it is obliged to carry out a technical evaluation of the manufacturer’s annual PQR. Based on this analysis, they must decide whether corrective or preventive actions (CAPA) are required to ensure product quality on a long-term basis.
- Contractual safeguards: The collaboration between the MAH and the manufacturer must be governed by comprehensive written contracts that set out responsibilities in detail. These Quality Agreements must now explicitly reflect the requirements of the new Article 3.
These regulations make it clear that, in future, the marketing authorisation holder will act as the central authority for quality assurance and must demonstrate that manufacturing processes are monitored without exception.
Strategic implementation and ongoing monitoring: how compliance is achieved!
The transition to the new regulatory framework requires an early and systematic review of existing quality management systems. Companies that only begin to adapt their processes shortly before the deadline in July 2026 face the risk that necessary changes to contracts, specifications or validation concepts cannot be completed in time.
A structured implementation process should therefore include the following steps:
- Gap analysis: A detailed comparison of existing processes with the requirements of Regulations (EU) 2025/2091 and 2025/2154, particularly with regard to the ‘shall’ principle and the new marketing authorisation holder obligations.
- Contract review: The revision of existing quality agreements between marketing authorisation holders and manufacturers to define responsibilities in accordance with Article 3 in a legally compliant manner.
- Training and awareness-raising: Preparing staff for the new terminology and the legal implications of the changes to establish a common understanding of the stricter requirements.
- Documentation update: Adapting the Site Master File (SMF) in accordance with the new template in Annex VI, and updating the validation master plans in line with Annex V.
It should be noted that regulatory compliance is not a static state, but requires continuous monitoring. The veterinary sector’s new autonomy could, in the long term, lead to greater divergence from human GMP rules, making it necessary to keep a close eye on regulatory developments and adapt corporate strategy flexibly.
The new regulatory framework as the foundation for quality and market success!
The introduction of Implementing Regulations (EU) 2025/2091 and 2025/2154 marks a fundamental turning point for the veterinary sector. It not only safeguards the integrity of manufacturing processes but, in particular, enhances the safety and efficacy of veterinary medicines on the European market. Manufacturers and marketing authorisation holders who implement this process holistically, carefully and in accordance with the new legal requirements will not only secure market access but also the trust of regulatory authorities and users.
Now is therefore the ideal time to critically review existing structures, implement the new responsibilities of the marketing authorisation holder and develop a future-proof compliance strategy in collaboration with experienced partners.
TentaConsult is your specialist partner for successfully navigating regulatory change. We support you every step of the way – from conducting detailed gap analyses and drafting legally compliant quality agreements to optimising your marketing authorisation strategies in line with the new regulatory framework, right through to providing targeted training for your team on the latest ‘shall’ requirements.
Get your company ready for Veterinary GMP 2026 now. Please feel free to contact us!
