Assessors training on limited markets classification and data requirements

Training objectives:

• Provide guidance on the classification of a product as intended for a limited market (as defined in Article 4(29) of Regulation (EU) 2019/6) and on the consideration of eligibility in accordance with Article 23 of Regulation (EU) 2019/6;

• Clarify safety and efficacy data requirements for applications for limited markets deemed eligible for authorisation under Article 23 of Regulation (EU) 2019/6, for both immunological and non-immunological veterinary medicinal products;

• Report on experience to date relating to classification of products as intended for limited markets and eligible for submission under Article 23 and how these requests were justified by the applicants.

Target audience: This training is aimed at safety and efficacy assessors from national competent authorities involved in the assessment of applications for immunological and non-immunological veterinary medicinal products intended for limited markets and potentially eligible for authorisation under Article 23 of Regulation (EU) 2019/6.   

Webinar registration open until 5 December 2024 (link)