Safety: veterinary limited markets

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 - Scientific guideline
• 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 - Scientific guideline
• Safety and residue data requirements for the establishment of maximum residue limits in minor species - Scientific guideline
• Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Scientific guideline
• Establishment of maximum residue limits for Salmonidae and other fin fish
• Availability of veterinary medicinal products - extrapolation of maximum residue limits