EudraVigilance Veterinary - Reporting

Overview

Requirements for reporting are set-out in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for veterinary as amended by Directive 2004/28/EC of the European Parliament and the Council of the 31 March 2004, and in Regulation 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

The Schemas for the Guidance on the Electronic Data Interchange of Safety Data for Veterinary Medicinal Products in the EU provide guidance for the operation of electronic reporting.  These schemas have been developed and agreed within the Veterinary Joint Implementation Group (JIG) at the agency (EMA) which includes regulatory authorities’ representatives as well as veterinary pharmaceutical industry representatives. Adherence to the schemas allows for electronic communication of Pharmacovigilance information with limited risks on the introduction of duplicates in the EudraVigilance Veterinary database.