Commission Implementing Regulation (EU) 2021/1281 laying down rules for the application of Regulation (EU) 2019/6 as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products.

This Regulation lays down the requirements for the marketing authorisation holder’s pharmacovigilance system established and maintained in accordance with Article 77(1) of Regulation (EU) 2019/6, including the establishment and implementation of an adequate and effective quality management system for the performance of their pharmacovigilance activities; setting up and maintaining a document management system to keep all documents related to pharmacovigilance activities; training all personnel involved in the performance of pharmacovigilance activities; performing audits of the pharmacovigilance system at regular risk-based intervals to ensure that it complies with the requirements set out in this Regulation; and managing corrective and preventive actions, to mitigate any deviations detected in audits, daily operational work and findings from inspections. This Regulation provides for the establishment of a record management system for receiving, recording, collating and assessing information on adverse events and for recording safety information. Furthermore, marketing authorisation holders shall record adverse events in the Union Pharmacovigilance database. Marketing authorisation holders shall ensure that the pharmacovigilance system includes a risk management system to take appropriate action to minimise identified risks, when necessary. The content and structure of the pharmacovigilance system master file are set out in Article 22. Marketing authorisation holders shall be prepared for inspections of their pharmacovigilance system and the corresponding pharmacovigilance system master file.