Chapter 3, Article 14 · Commission Implementing Regulation (EU) 2021/1281

Contents

Article 14Provision of additional data#

1.To enable comprehensive analysis of adverse event reports from third countries, marketing authorisation holders shall record in the Union product database the corresponding product names and authorisation numbers for the same product or, if the same product is not authorised in the Union, for a similar product authorised in the Union, as defined in the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) Guideline 24^note. Marketing authorisation holders shall update the information when necessary.

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.

3.The Agency shall publish guidance on the mathematical formula to calculate the factor. Marketing authorisation holders shall record their assumptions on distribution of sales per target species and treatment regimen per target species that they use for the calculation of the factor in the pharmacovigilance system master file. Marketing authorisation holders shall update the factor when necessary.

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Defined terms · 3

Show every defined term

performance indicator
means an item of information collected at regular intervals to monitor the performance of a system;
quality management system
means a formalised system that provides for comprehensive processes, procedures, and responsibilities for achieving quality policies and objectives to coordinate and direct an organisation’s activities and improve its effectiveness and efficiency in this regard on a continuous basis;
signal
means information that arises from one or multiple sources, including observations and experiments, which suggests a potentially new causal association, or a new aspect of a known causal association between an intervention and an adverse event or a set of related adverse events, that is judged likely to justify further investigation of possible causality.