Classification of a product as intended for a limited market and eligibility for authorisation under Article 23 of Regulation (EU) 2019/6 (Applications for limited markets)

This reflection paper defines the eligibility criteria for applications for veterinary limited markets under the Veterinary Medicines Regulation (Regulation (EU) 2019/6), which became applicable on 28 January 2022.

The reflection paper covers:

• confirmation of classification of a product as intended for a limited market under Article 4(29) of the Regulation;
• confirmation on eligibility under Article 23 of the Regulation.
• considerations for addressing the requirements for re-examination under Article 24 of the Regulation.

The criteria apply to all applications for veterinary limited markets, irrespective of the authorisation route.

Keywords: availability, limited market, classification, Article 23, Article 24, eligibility, Regulation 2019/6, veterinary medicinal products