Concept paper on pharmacovigilance implementing measures released for consultation

The European Commission is seeking views from the public on a concept paper on implementing measures for the performances of activities related to the safety monitoring of medicines.

The European Commission is seeking views from the public on a concept paper on implementing measures for the performances of activities related to the safety monitoring of medicines.

The paper is open for consultations until November 7 2011 and provides technical details that the European Medicines Agency, medicines regulatory authorities in the European Union, member states and marketing authorization holders will need to apply when implementing the new phamacovigilance legislation.

The Agency and representatives from member states provided technical expertise to help with the preparation of this document. The document is available on the European Commissions pages. 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.