Reflection paper on the application of Regulation (EU) 2019/6 for certain categories of variations

Article 40(5) of the Regulation confers four years of data protection for variations involving a change to the pharmaceutical form, administration route or dosage assessed as having demonstrated:

1. a reduction in the antimicrobial or parasiticide resistance, or
2. an improvement of the benefit-risk balance of the veterinary medicinal product (VMP).

The data protection applies to the results of the pre-clinical studies or clinical trials provided in support of the variation. The reflection paper outlines the potential criteria to support the demonstration of a reduction in the antimicrobial or antiparasitic resistance, or an improvement of the benefit-risk balance.

Keywords: Veterinary, Article 40(5), data protection, protection of technical documentation ; variations, reduction antimicrobial resistance, reduction antiparasitic resistance, improvement benefit-risk balance, Regulation (EU) 2019/6, CVMP

Current version

Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations

Draft: consultation closedConsultation dates: 24/11/2022 to 28/02/2023Reference Number: EMA/CVMP/64911/2021

Document history

Concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6

Draft: consultation closedConsultation dates: 20/07/2020 to 21/09/2020Reference Number: EMA/CVMP/340959/2020