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

Reflection paper

Reflection paper on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets)

Reference Number: EMA/CVMP/235292/2020 Legal effective date: 28/01/2022

This document is currently under revision. Please consult Guidance to Applicants - Veterinary Medicinal Products for up to date information.

Document history

Overview of comments received on 'Reflection paper on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets)'

Reference Number: EMA/CVMP/147858/2021

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)

Draft: consultation closed Consultation dates: 25/02/2021 to 15/05/2021 Reference Number: EMA/CVMP/235292/2020 Summary:

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.