On 22 May 2026, the European Medicines Agency (EMA) published a guidance document under Article 141(1)(f) of Regulation (EU) 2019/6 on veterinary medicinal products, addressing the application of Articles 107(6) and 114(3). The guidance aims to clarify regulatory requirements for the authorisation and use of veterinary medicines, impacting manufacturers, importers, and national competent authorities.
The document, issued by EMA's Veterinary Medicines Division, provides interpretative guidance on the conditions under which certain veterinary medicinal products may be exempt from specific regulatory provisions. Article 107(6) concerns the exceptional authorisation of veterinary medicinal products without a marketing authorisation in the case of serious disease outbreaks or public health threats, while Article 114(3) relates to the use of antimicrobial veterinary medicinal products for prophylactic purposes. The guidance sets out criteria and procedural steps for requesting such exemptions, including documentation requirements and risk assessment considerations.
Policy orientations and trade-offs
The guidance balances the need for rapid access to veterinary treatments during emergencies with the imperative to combat antimicrobial resistance (AMR). By specifying strict conditions for prophylactic antimicrobial use, EMA aims to reduce unnecessary exposure of animals to antibiotics, a key driver of AMR. However, the guidance also acknowledges the practical challenges faced by veterinarians and farmers in disease prevention, allowing limited flexibility under defined circumstances. The document does not introduce new mandatory targets but rather clarifies existing legal provisions, making it a non-binding interpretative tool.
Impact on stakeholders
Veterinary pharmaceutical manufacturers will need to align their emergency authorisation requests with the detailed procedural requirements, potentially increasing administrative burden for small and medium-sized enterprises. National competent authorities gain clearer criteria for evaluating exceptional authorisations, which may streamline decision-making during outbreaks. Veterinarians and livestock farmers benefit from more predictable pathways to access critical medicines, but face tighter restrictions on prophylactic antimicrobial use, which could increase reliance on alternative disease prevention measures. Public health and AMR advocacy groups are likely to view the guidance positively as it reinforces the EU's commitment to prudent antimicrobial use.
Expected institutional follow-up
The guidance is effective immediately upon publication. EMA may update it based on experience gained from its application or in light of new scientific evidence. National authorities are expected to incorporate the guidance into their regulatory practices, and EMA will monitor its impact through the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) network.