Regulation (EU) 2019/6 provides for the establishment of an EU-wide pharmacovigilance system led by the European Veterinary Medicines Agency in collaboration with the Member States for all medicinal products authorised in at least one EU country.
Until then, the pharmacovigilance system in force in the European Union provided for the obligation for marketing authorisation holders to submit to the EMA and the Member States their assessment of the benefit-risk of their medicinal products via periodic safety-relatisf update reports, including notifications of all adverse reactions and an estimate of the number of animals treated over the period for calculating the incidence of the various reported adverse reactions. Those reports had to be submitted by the marketing authorisation holder, immediately upon request or in accordance with a precise timetable after placing on the market and accompanied by a scientific assessment of the benefit/risk balance of the veterinary medicinal product irrespective of the veterinary medicinal product’s age on the market.
The new regulation introduces a change in pharmacovigilance and a change of approach. The reform now implements a signal management process to ensure “active monitoring of pharmacovigilance data on veterinary medicinal products with a view to assessing and assessing whether the benefit/risk balance of these medicinal products has evolved, with a view to detecting risks to animal or public health and to the protection of the environment”.
In pharmacovigilance, a ‘signal’ means information from one or more sources suggesting a possible new causal association or a new aspect of a known causal association between a medicinal product and an adverse event.
Signal detection facilitates early detection of potential safety issues (adverse events, product interactions, etc.) and includes at least stages of detection, prioritisation, validation, signal evaluation and documentation of results.
Article 81 of the Regulation states that marketing authorisation holders may, if necessary, take into account, in the context of that signal management process, the volume of sales and other relevant pharmacovigilance data of which they are reasonably expected to be aware, in particular information from scientific journals.
The results and conclusions of this signal management process including the conclusion on the benefit-risk balance shall be recorded by the MA holder in the Union pharmacovigilance database at least once a year.
The Member States and the EMA shall define the procedures necessary to assess the results and conclusions of holders in this process and those applicable to individual adverse event reports.
Each holder shall have at least one pharmacovigilance system master file describing in detail the system put in place to meet his pharmacovigilance obligations.
The competent authorities shall ensure compliance with these obligations through controls and/or inspections.