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Risk Management

A European Regulatory Perspective

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Abstract

Risk management for European regulators means the detection and assessment of risks, the development and selection of measures to reduce risk, and monitoring of the effectiveness of risk control; all aspects of pharmacovigilance intended to minimise risk to European Union citizens associated with use of medicinal substances. This incorporates earlier and better planning of pharmacovigilance through formal product risk-management plans, better use of information tools to protect public health and routine audit of effectiveness of regulatory action.

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Table I

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Notes

  1. Member States are: Belgium, France, Germany, Italy, Luxembourg, The Netherlands, Denmark, Ireland, United Kingdom, Greece, Spain, Portugal, Austria, Finland, Sweden, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovak Republic and Slovenia.

References

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  2. The Gateway to the European Union [online]. Available from URL: http://www.europa.eu.int/ [Accessed 2004 Feb]

  3. Council Regulation (EEC) No 2309/93, of 22 July 1993, laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. (Amended by Commission Regulation (EC) No 649/98 of 23 March 1998 amending the Annex to Council Regulation (EEC) No 2309/93) Official Journal of the European Communities L 214, 24/08/1993 P. 0001–0021 Finnish special edition: Chapter 13 Volume 24 P. 0158 Swedish special edition: Chapter 13 Vol. 24 P. 0158

  4. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. (Amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Amended by Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use). Official Journal of the European Communities L 311, 28/11/2001 P. 0067–0128

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  6. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official Journal of the European Communities L 136, 30.4.2004 P. 0001–0033

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Acknowledgements

The views expressed are those of the author. This review does not constitute formal regulatory guidance. Relevant formal European guidance documentation and legislation as appropriate should be consulted for detailed pharmacovigilance obligations.

No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review.

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Authors and Affiliations

  1. Pharmacoepidemiology Research Team, The Medicines and Healthcare products Regulatory Agency, Room 15-206 Market Towers, No 1 Nine Elms Lane, London, SW8 5NQ, UK

    Jane N. S. Moseley

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Moseley, J.N.S. Risk Management. Drug-Safety 27, 499–508 (2004). https://doi.org/10.2165/00002018-200427080-00003

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