Safety guidelines: veterinary limited markets
VeterinaryRegulatory and procedural guidanceResearch and developmentScientific guidelines
Swedish is available via eTranslation, the European Commission's machine translation service.
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The European Medicines Agency's scientific guidelines on the availability of veterinary medicinal products for minor use/minor species help medicine developers prepare marketing authorisation applications.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
- Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6
- Safety and residue 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
- Safety and residue data requirements for the establishment of maximum residue limits in minor species
- Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
- Establishment of maximum residue limits for Salmonidae and other fin fish
- Availability of veterinary medicinal products - extrapolation of maximum residue limits