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SubscribeCommission Implementing Regulation (EU) 2025/2091 establishing Good Manufacturing Practice for Veterinary Medicinal Products was published on 27 October 2025.
To date, the manufacture of veterinary medicinal products is governed by the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (Volume 4 of EudraLex).
Effective date and application
Without prejudice to the fact that Implementing Regulation (EU) 2025/2091 entered into force on 16 November 2025, the diploma will only be applicable in the different Member States from 16 July 2026.
The Commission recognized that it was important to ensure that competent authorities and other stakeholders have sufficient time to adapt to the new rules, even if they are aligned with the requirements already known to operators under the old Directive 2001/82/EC.
As it is an Implementing Regulation, it is mandatory for all Member States of the European Union and will be directly applicable to them, without the need for transposition.
Novelties
Operators in the veterinary medicines manufacturing sector will have, as of 16 July 2026, guidelines applicable exclusively to veterinary medicines. Nevertheless, the vast majority of Implementing Regulation (EU) 2025/2091 corresponds to the different chapters of Volume 4 of Eudralex and therefore has a structure that will be familiar to operators in the sector.
Thus, Implementing Regulation (EU) 2025/2091 formalizes and brings together in a single legal text the various existing guidelines on Good Manufacturing Practices for Veterinary Medicinal Products.
Nevertheless, it is relevant to highlight the new role of the market authorization holder in relation to good manufacturing practice. Implementing Regulation (EU) 2025/2091 has a rule that expressly assigns, in a separate article, responsibilities to the MAH holder within the scope of Good Manufacturing Practices, something that the standards and guidelines currently in force do not consolidate in a dedicated article. So, what is this new role?
- Continuous alignment with the MA: The MAH holder now has an express obligation to ensure that all specifications and instructions provided to the manufacturer are aligned with the terms of the marketing authorization and to communicate approved or submitted variations without delay.
- Evaluation of the periodic quality review: where the marketing authorization holder is not the manufacturer, it has an express obligation to evaluate the results of the annual product quality review and to determine whether corrective or preventive action is required.
- Mandatory contractual formalization: The Implementing Regulation requires, more comprehensively than Volume 4 of Eudralex, a written agreement between the MAH holder and the manufacturer that governs all responsibilities and reciprocal obligations between the MAH holder and the manufacturer.
In summary, Implementing Regulation (EU) 2025/2091 represents a relevant step in the consolidation and modernization of Good Manufacturing Practices applicable to veterinary medicinal products. While it maintains a strong correspondence with Volume 4 of EudraLex, it introduces for the first time a clear and autonomous legal framework for the veterinary sector.
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