On 22 May 2026, the European Medicines Agency (EMA) published guidance under Article 141(1)(f) of Regulation (EU) 2019/6 concerning five veterinary medicinal substances that are not included in Commission Implementing Regulation (EU) 2025/901. The document clarifies the regulatory status and requirements for these substances, impacting manufacturers, importers, and national competent authorities.
The guidance addresses substances that were omitted from the 2025 implementing regulation, which lists active substances for veterinary use. For each of the five substances, EMA specifies whether they are considered existing or new, and outlines the necessary steps for compliance, including data requirements and timelines. The document aims to ensure a harmonised approach across Member States and prevent market fragmentation.
Stakeholder impact Veterinary pharmaceutical companies face potential additional costs for generating missing data or adjusting product dossiers. National authorities will need to align their procedures with the guidance, which may require training or resource allocation. Animal health professionals and livestock producers could experience temporary supply disruptions if products need reauthorisation. Consumer safety is indirectly strengthened through clearer regulatory oversight.
Institutional follow-up The guidance is immediately applicable. EMA may update it based on feedback from stakeholders or new scientific evidence. The European Commission is expected to monitor implementation and could propose amendments to the 2025 regulation if gaps persist.
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