Key takeaways

• Since July 2026 new rules are force which apply to veterinary medicines manufacturers
• Manufacturers, importers and marketing authorisation holders of veterinary products should therefore assess their quality systems, Qualified Person procedures, documentation and outsourcing arrangements against the codified requirements
• Further simplification to variation procedures, streamlined GMO approvals and new incentives for biotechnology-derived veterinary medicines, may be on the way as part of Biotech Act I

Since 16 July 2026, veterinary medicines manufacturers have been subject to a restructured good manufacturing practice (“GMP”) framework. Two new EU Regulations introduce standalone GMP rules for the veterinary sector: Commission Implementing Regulation (EU) 2025/2091 on GMP for veterinary medicinal products (PDF, 2.5MB) (“VMPs”) (“the GMP Regulation”), and Commission Implementing Regulation (EU) 2025/2154 (PDF, 1.2MB) on GMP for active substances used as starting materials in VMPs (“the Active Substances Regulation”). Together, they implement Article 93 of Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC (PDF, 1.7MB) (the “VMP Regulation”) and replace the previous veterinary GMP framework, which was based mainly on an older Directive 91/412/EEC and the relevant EU GMP Guide provisions.

Separately, the European Commission’s proposed European Biotech Act (“Biotech I”), published in December 2025, sets out targeted veterinary medicines reforms aimed at reducing regulatory burden and supporting innovation.

A new standalone GMP framework

The GMP Regulation sets the core GMP requirements for manufacturers and importers of finished VMPs, built around key principles including:

• a risk-based pharmaceutical quality system (“PQS”)
• documented management oversight and self-inspection
• Qualified Person (“QP”) certification and batch release
• controls for personnel, premises, equipment and documentation
• production and quality control
• stability monitoring and sample retention
• outsourced activity management
• complaints, quality defects and recalls

A key change is that requirements previously reflected in guidance, expressed as ‘should’, are now directly applicable law, using mandatory ‘shall’ language. The Regulation is supported by six Annexes covering areas such as sterile and aseptic manufacture, computerised systems and data integrity and Site Master Files.

The Commission has published correspondence materials mapping old requirements to the new framework. Manufacturers should review their quality systems, batch certification and documentation against these new, directly applicable requirements. Alignment with existing GMP principles is still the objective.

Requirements for active substances

The Active Substances Regulation creates standalone GMP rules for active substances used as starting materials in VMPs. It supplements Article 93 of the VMP Regulation, which requires active substances in VMPs manufactured or imported into the Union to be produced in accordance with GMP. Broadly aligned with recognised active-substance GMP standards, it focuses on:

• risk-based quality management
• an independent quality unit
• annual product quality reviews
• self-inspection and audits
• premises, equipment and documentation requirements
• computerised-system and data-integrity controls
• outsourced-activity governance

It also contains specific rules and exclusions for certain sterile, biological and herbal active substances while remaining aligned with the wider veterinary GMP framework.

A final related amendment, Commission Implementing Regulation (EU) 2026/857, has updated the retention sample rules for repackaged parallel-traded VMPs from 16 July 2026, allowing photographic or digital samples to replace physical samples in some cases, subject to prior approval by the national competent authority and safeguards.

Biotech I: veterinary medicines reforms

Alongside the GMP reforms, the Commission is pursuing broader veterinary-sector changes. Biotech I would amend the VMP Regulation as part of a wider strategy to promote biotechnology innovation, streamline regulation and support EU competitiveness. The Commission identifies two main issues: disproportionate administrative burdens in certain procedures and complexity from overlaps between veterinary medicines and EU GMO legislation. Some of the Biotech I’s proposals include:

• Simplifying variations not requiring assessment: For many marketing authorisation holders, the most immediately relevant proposal concerns variations not requiring assessment (“VNRAs”). The Commission proposes annual consolidation of certain VNRAs that do not affect product information and removal of confirmation requirements for some VNRA procedures. The aim is to reduce administrative burden for industry and competent authorities while maintaining quality, safety and efficacy standards. The HPRA identified these reforms as likely to deliver significant operational benefits if adopted.
• A GMO “one-stop-shop” for veterinary medicines: The proposal also addresses duplication for VMPs containing or consisting of genetically modified organisms. Certain GMO-containing VMPs would be assessed only under the VMP Regulation rather than through parallel veterinary medicines and GMO authorisation procedures. It would also clarify that animals treated with GMO-containing VMPs are not, for that reason alone, GMOs under EU law.
• An SPC incentive for biotechnology products: The Biotech Act proposes an additional 12-month Supplementary Protection Certificate (“SPC”) extension for qualifying biotechnology-derived VMPs intended to diagnose, prevent or treat zoonotic diseases. Eligibility would depend on conditions including novelty and performance of at least part of the manufacturing process in the EU, with the aim of supporting innovation and investment in strategically important biotechnology products.
• A regulatory sandbox for animal health innovation: The proposal would introduce an animal health regulatory sandbox. On EMA recommendation, the Commission could establish sandboxes allowing innovative technologies or products to be developed and assessed in a controlled regulatory environment. The Commission views this as a way to support emerging technologies that do not fit neatly within existing frameworks while maintaining safeguards.

What manufacturers need to do now

Together, these developments mark a significant shift for the veterinary sector. The new GMP Regulations placed quality obligations on a standalone legislative footing from a single commencement date of 16 July 2026, with no phase-in by product type or company size. All manufacturers, importers and active-substance suppliers have been subject to the codified requirements since that date. Manufacturers, importers and marketing authorisation holders should therefore assess their quality systems, QP procedures, documentation and outsourcing arrangements against the codified requirements.

Biotech I, by contrast, remains only a proposal. It is not yet in force, and its provisions and timing may change as it progresses through the legislative process.

Given that the GMP changes are already in force, manufacturers should prioritise the following actions now:

• Benchmark against the new “shall” obligations. Map current quality systems, standard operating procedures and batch documentation against the mandatory “shall” obligations set out in both the GMP Regulation and the Active Substances Regulation, both of which are drafted in directly binding terms rather than as guidance, using the Commission’s correspondence tables as a starting point.
• Update QP and batch release procedures. Review Qualified Person certification and batch release procedures against the standalone GMP Regulation itself, rather than the now-superseded GMP Guide chapters.
• Active-substance manufacturers and importers. Confirm that the independent quality unit, annual product quality review and self-inspection programme satisfy the Active Substances Regulation, a distinct obligation from finished-product GMP compliance.
• Parallel-trade repackaging operations. Check retention-sample practice against the updated rules in Regulation (EU) 2026/857. Where a photographic or digital sample is proposed in place of a physical sample, obtain prior approval from the competent authority before relying on it.
• Revisit outsourcing and contract-manufacturing arrangements, including documented management oversight procedures, as these are now directly enforceable obligations rather than guidance.

For more information, please contact a member of our Life Sciences Group.

The authors would like to thank Jack Kenny for his contribution to this briefing.