Immunologicals: guidelines - Veterinary limited markets

The European Medicines Agency's scientific guidelines on the availability of immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Guidelines

• Data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6
• Safety and efficacy data requirements for applications for immunological VMPs intended for limited markets but not eligible for authorisation under Art 23 of Reg (EU) 2019-6
• Quality data requirements for applications for biological veterinary medicinal products intended for limited markets
• Data requirements for immunological veterinary medicinal products intended for minor use or minor species