Data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline

This guideline defines the acceptable data requirements on safety and efficacy for marketing authorisation applications for immunological veterinary medicines intended for veterinary limited markets under Article 23 of the Veterinary Medicines Regulation (Regulation (EU) 2019/6).

The Regulation became applicable on 28 January 2022.

This guideline replaced the Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (EMEA/CVMP/IWP/123243/2006 Rev. 3). 
 

Keywords: availability, limited market, classification, Article 23, Article 24, eligibility, Regulation 2019/6, immunological veterinary medicinal products, safety and efficacy data

Guideline

Guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6

AdoptedLegal effective date: 28/01/2022Reference Number: EMA/CVMP/59531/2020

Document history

Draft guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6

Consultation dates: 25/02/2021 to 15/05/2021Draft: consultation closedReference Number: EMA/CVMP/59531/2020Summary:

This draft guideline defines the acceptable data requirements on safety and efficacy for marketing authorisation applications for immunological veterinary medicines intended for veterinary limited markets under Article 23 of the Veterinary Medicines Regulation (Regulation (EU) 2019/6).

The Regulation becomes applicable on 28 January 2022.

This guideline will replace the Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (EMEA/CVMP/IWP/123243/2006 Rev. 3). 

Overview of comments received on 'Guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6' (EMA/CVMP/59531/2020)

Reference Number: EMA/CVMP/147910/2021