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)
Table of contents
This reflection paper defines the eligibility criteria for applications for veterinary limited markets under the Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes 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 will 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
Reflection paper on classification of a product as intended for a limited market and eligibility for authorisation according to Article 23 (Applications for limited markets) (PDF/421.09 KB)Draft: consultation open
First published: 25/02/2021
Consultation dates: 25/02/2021 to 15/05/2021