The document provides details on:
- pharmacovigilance system master files;
- the quality system for the performance of pharmacovigilance activities;
- the use of internationally agreed terminology, formats and standards;
- monitoring data in the EudraVigilance database;
- the electronic transmission of suspected adverse reactions;
- electronic periodic safety update reports and risk-management plans;
- post-authorisation safety studies.
The Agency and representatives from Member States provided technical expertise to help with the preparation of this document.
The concept paper is available to download from the European Commission's pages on pharmacovigilance. All comments on the paper should be sent directly to the Commission.
This consultation process is a key step in the implementation of the pharmacovigilance legislation. The Agency is working closely with the European Commission, as well as national medicines regulatory authorities, patients, healthcare professionals and pharmaceutical companies, to ensure the effective implementation of the new legislation.
The launch of this consultation is in line with the target in the implementation plan for the new legislation.