Contents
2.The total number of animals displaying an adverse event during a defined period of time, multiplied by 100 and divided by an estimate of the number of animals treated during that period, shall provide the incidence of reported adverse events. To calculate the estimated number of animals treated from the information on volume of sales required under Article 58(12) of Regulation (EU) 2019/6, marketing authorisation holders shall identify and provide a factor to the Union product database for each of their veterinary medicinal products according to country, target species and pack size. According to the posology of the product, the factor will determine how many animals can be treated with one package of a given pack size, regardless of the formulation. To calculate the incidence for adverse event reports from third countries via the estimated number of animals treated, marketing authorisation holders shall provide information on volume of sales for each of their veterinary medicinal products, combined for all third countries according to target species, and in regard to the same or a comparable pack size.
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