Ecolex Logo
The gateway to
environmental law
Search results » Legislation

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.

Country/Territory
European Union
Document type
Regulation
Date
2021
Source
FAO, FAOLEX
Original source
Official Journal of the European Union L 279, 3 August 2021, pp. 15-29.
Subject
Livestock, Fisheries
Keyword
Authorization/permit Business/industry/corporations Capacity building Certification Data collection/reporting Inspection Risk assessment/management Drugs Fish disease Animal health
Geographical area
European Union Countries
Entry into force notes
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union and shall apply from 28 January 2022.
Abstract

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.

Full text
English
Website
eur-lex.europa.eu

References - Legislation

Implements

Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC.

Legislation | European Union | 2018 (2022)

Keyword: Aquaculture, Aquatic animals, Fish disease, Drugs, Animal health, Basic legislation, Internal trade, International trade, Authorization/permit, Access-to-information, Inspection, Offences/penalties, Business/industry/corporations

Source: FAO, FAOLEX

Implemented by

Loi sur les médicaments vétérinaires.

Legislation | Belgium | 2022

Keyword: Animal health, Authorization/permit, Basic legislation, Pests/diseases, Inspection, Institution, Public health, Risk assessment/management, Drugs

Source: FAO, FAOLEX