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

Table of contents


Article 40(5) of the Regulation confers 4 years of data protection for variations involving a change to the pharmaceutical form, administration route or dosage assessed as having demonstrated:
a)    a reduction in the antimicrobial or parasiticide resistance, or 
b)    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 CVMP 2020 workplan foresees the development of scientific criteria to support the practical application of Article 40(5). This concept paper has been prepared with the aim to develop a reflection paper on the types of criteria that could be developed for the application of Article 40(5) via all routes of authorisation: centralised, decentralised, mutual recognition or nationally.

Keywords: NVR, Veterinary, Article 40(5)/40.5, data protection, variations, reduction antimicrobial resistance, reduction antiparasitic resistance, improvement benefit-risk balance, Regulation (EU) 2019/6, CVMP



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