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EEA - An Overview of Requirements Impacting Industry

Pharmacovigilance requirements in the EU are laid down in a variety of different documents, applicable according to the status and route of authorisation (such as pre- or post-approval, centrally or nationally approved). As it can be difficult for experienced personnel in this field, yet alone a newcomer, to digest these overlapping and detailed requirements, this article provides an overview of the reporting requirements applicable to the Marketing Authorisation Holder (MAH); gives sources for further information; and reviews possible changes arising as part of the current legislative review and as the EU moves towards enlargement.

The Basic Framework

Pharmacovigilance requirements in the EU are laid down in EU Regulations (540/95 (1) and 2309/93 (2), EU Directives 65/65 (3), 75/319 (4), 2000/38 (5) and 2001/83 (6)) and EU Guidelines (for example Notice to Marketing Authorisation Holders: Volume 9 - Pharmacovigilance Guidelines (7). There are also several policy papers relating to more specific functions, for example the concept paper on monitoring compliance (CPMP (Committee for Proprietary Medicinal Products) /PhVWP (Pharmacovigilance Working Party)/1618/01 (8)) and the EMEA (European Medicines Evaluation Agency) policy paper on electronic transmission (EMEA/H/5255/01 (9)). In addition, the EU Clinical Trials Directive (2001/20/EC (10)) lays down the basis for reporting from the clinical study environment, with relevant guidances currently being finalised.


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By Margaret Walters, Director of Pharmacovigilance at Merck Sharp & Dohme

Margaret Walters is currently Director of the European Office of Pharmacovigilance for Merck Sharp & Dohme Ltd. She has more than 16 years' experience in many areas of pharmacovigilance along with a further 10 years in basic research at Wellcome. Margaret is a member of the EFPIA Pharmacovigilance Ad Hoc group, co-chairs the PhRMA (EU) Pharmacovigilance team, is active in the EMEA/EFPIA Joint Working Party on Electronic Submissions and was part of the original (pre-ICH) MCA MedDRA Working Party.

She is also the author of several papers and her academic links include acting as External Adviser to the Postgraduate Diploma in Pharmacovigilance at the University of Hertfordshire.

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Margaret Walters
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