Both Article 106 of Directive 2001/83/EC and Article 24 of Regulation (EEC) No. 2309/93 require the Commission, in consultation with the Agency, the Member States and interested parties, to produce guidance on the collection, verification and presentation of adverse reaction reports, so as to facilitate the exchange of pharmacovigilance information within the EU. All Commission guidance must take account of international harmonisation work on pharmacovigilance terminology and classification.
In accordance with this requirement, the Commission provides guidance on the interpretation and implementation of pharmacovigilance requirements in Volume 9 of The Rules Governing Medicinal Products in the European Union (Volume 9 (see Appendix 4)). For ease of reference, it should be noted that although Volume 9 was recently updated and replaces all pharmacovigilance guidance published by the Commission prior to 30 September 2001, it has yet to be revised to take account of the codification in Directive 2001/83/EC (and Directive 2001/82/EC which relates to veterinary medicinal products).
The Agency is advised by a scientific committee, the Committee for Proprietary Medicinal Products. A sub-division of this committee is the Pharmacovigilance Working Party, which has a mandate to provide a forum for discussion, consensus development and co-ordination of pharmacovigilance issues at EU level with which Member States are required to co-operate. The Pharmacovigilance Working Party produces documents which supplement the guidance in Volume 9; these are identified in Part IV of Volume 9.
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