• Regular reports on the safety of veterinary medicinal products (Periodic Safety Update Report - PSUR)

Until the application of Regulation (EU) 2019/6, starting on 28 January 2022, the marketing authorisation holder for a veterinary medicinal product was obliged to submit periodic safety update reports (PSUR) to the national competent authority. On the basis of these data, a scientific assessment of the benefit- risk balance of the use of the veterinary medicinal product concerned was carried out by the BVL and documented in an assessment report.

Regular reports on the safety of veterinary medicinal products (Periodic Safety Update Report - PSUR)

With the application of Regulation (EU) 2019/6 from 28 January 2022, the obligation for marketing authorisation holders of veterinary medicinal products to submit PSURs has ceased.

Before 28 January 2022, based on the data collected in the PSURs (adverse events of a veterinary medicinal product occurring worldwide in relation to the sales volume or the estimated number of animals treated, respectively, but also new findings from studies or literature), a scientific assessment of the benefit-risk balance of the use of the veterinary medicinal product concerned was carried out and documented in an assessment report by the BVL. This process is replaced by the signal management process.

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