Guidance

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Chapter: Pharmacovigilance: Legal Basis – EU

Article 106 of Directive 2001/83/EC and Arti-cle 26 of Regulation (EC) No. 726/2004


GUIDANCE

Both Article 106 of Directive 2001/83/EC and Arti-cle 26 of Regulation (EC) No. 726/2004 require the Commission, in consultation with the Agency, the Member States and interested parties, to produce guid-ance on the collection, verification and presentation of adverse reaction reports so as to facilitate the exchange of pharmacovigilance information within the EU. All such guidance must take account of inter-national harmonisation work on pharmacovigilance terminology and classification, and the Commission is required to publish a reference to an internationally agreed medical terminology.

In accordance with this requirement, the Commis-sion provides guidance on the interpretation and implementation of pharmacovigilance requirements in Volume 9 of The Rules Governing Medicinal Products in the European Union. For ease of refer-ence, it should be noted that although Volume 9 replaces all pharmacovigilance guidance published by the Commission before June 2004, there is presently a draft of Volume 9a that deals with the changes introduced by the EU Pharma Review.

The Agency is advised by a scientific committee, the Committee for Medicinal Products for Human Use (‘CHMP’). 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 Work-ing Party produces documents which supplement the guidance in Volume 9; these are identified in Part IV of Volume 9.

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