Efficacy: veterinary limited markets
VeterinaryRegulatory and procedural guidanceResearch and developmentScientific guidelines
On Monday, 12 January 2026, between 07:00 and 10:00 CET (Amsterdam time), this website will be unavailable due to scheduled maintenance.
The European Medicines Agency's scientific guidelines on the availability of veterinary medicinal products for limited markets help medicine developers prepare marketing authorisation applications.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
- Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6 - Scientific guideline
- Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 - Scientific guideline