CVMP guidance adopted in January now available online

The guidance documents adopted by the CVMP in their January meeting have now been published on the EMA website:

• Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (Link)
• Draft guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (Link)
• Draft guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (Link)
• Draft guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (Link)
• Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances (Link). An overview of comments received during the consultation is also available (Link)
• Concept paper for the revision on the guideline for the conduct of pharmacokinetic studies in target animal species (Link)