The Agency

Article 20 requires the Agency to co-operate with the national pharmacovigilance systems, in order to receive all relevant information about suspected adverse reactions to authorised medicinal products in the EU. If necessary, the Agency's Committee for Proprietary Medicinal Products will provide opinions on the measures necessary to ensure the safe and effective use of particular medicinal products.

The EudraNet system, an electronic data-processing network, has been developed to enable the rapid transmission of data between the competent EU authorities in the event of an alert relating to faulty manufacture, serious adverse reactions and other pharmacovigilance data. Although at this stage, not all competent authorities are using EudraNet for pharmacovigilance reporting, it is envisaged that this will eventually replace paper reporting. The Agency is required to evaluate the pharmacovigilance information it receives and to make this information available through a database (Article 51c). To meet this requirement, the EudraVigilance system is currently being developed within EudraNet, following International Conference on Harmonisation (ICH) guidelines and recommendations.

The Agency is also responsible for collaboration with the World Health Organisation (WHO) on international pharmacovigilance, and to take any steps necessary to submit appropriate and adequate information promptly to the WHO regarding the measures taken in the EU which may have a bearing on public health protection in third countries (Article 25). The Pharmacovigilance Working Party of the Committee on Proprietary Medicinal Products produces guidance documents on a wide range of pharmacovigilance issues, including the principles of providing the WHO with pharmacovigilance information (see Chapter 2.6 of Volume 9 and CPMP/PhVWP/053/98 at Appendix 5).

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