The European Medicines Agency (EMA) has published a document responding to a European Commission request for guidance on scientific issues related to Articles 107(6) and 114(3) of Regulation (EU) 2019/6 on veterinary medicinal products. The document, dated 22 May 2026, clarifies the procedures for referral and arbitration in cases where EU member states disagree on the authorisation or safety of veterinary medicines. It impacts veterinary pharmaceutical companies, national competent authorities, and animal health stakeholders by providing a standardised framework for resolving scientific disputes.
The document is a formal response to a Commission request, outlining EMA's role in providing scientific opinions when member states cannot reach consensus on marketing authorisations or post-authorisation safety issues. It specifies the timelines, evidence requirements, and the involvement of EMA's Committee for Veterinary Medicinal Products (CVMP). While the guidance is not legally binding, it sets expectations for how EMA will handle referrals under the 2019 regulation, which aims to harmonise the EU veterinary medicines market.
Policy orientations and trade-offs The guidance balances the need for scientific rigour with procedural efficiency. It emphasises that EMA's opinions should be based on a comprehensive assessment of benefit-risk, but also notes that rapid resolution is critical to avoid delays in access to veterinary medicines. This creates a trade-off between thorough evaluation and timely decision-making, potentially affecting smaller companies with limited resources to compile extensive data.
Impact on stakeholders Veterinary pharmaceutical companies will face clearer expectations for referral submissions, potentially reducing uncertainty but also increasing administrative burden. National authorities gain a structured process for escalating disputes, which may streamline cross-border disagreements. Animal health professionals and livestock owners could benefit from faster resolution of safety concerns, though the guidance does not directly address pricing or availability. The CVMP will see an increased workload as the central arbiter of scientific disagreements.
Institutional follow-up The EMA guidance is expected to inform future Commission implementing acts and may be updated based on practical experience. Stakeholders have been invited to provide feedback during a public consultation period ending 22 August 2026. The European Parliament and Council may also review the guidance as part of broader oversight of the veterinary regulation's implementation.
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