Within the European Union (EU), the pharmaceutical industry is a highly regulated sector. The level of regulation reflects the potential hazards associated with the use of medicinal products. Subject to a limited number of exceptions, all medicinal products placed on the market within the EU must have a marketing authorisation. The grant of a marketing authorisation signifies that a medicinal product complies with the quality, safety and efficacy criteria set out in European medicinal product regulatory law.

Marketing authorisations for products to be placed on the EU market are granted:

* on a national basis by the competent authority of a Member State (where the product will be marketed in one Member State only); or

* through the mutual recognition procedure, where a marketing authorisation granted by the competent authority of an original Reference Member State is accepted by the competent authorities of other Member States;

* since 1 January 1995, on a EU basis by the European Commission (the Commission) under the centralised procedure, in accordance with the provisions of Regulation (EEC) No. 2309/93.

Pharmacovigilance requirements apply to all authorised medicinal products on the market in the EU and EFTA states (Iceland, Liechtenstein and Norway). Both human use and veterinary medicinal products are subject to these requirements; this chapter outlines the requirements for human use medicinal products only.

The need for pharmacovigilance arises from the fact that, despite extensive clinical trials at the

Pharmacovigilance. Edited by R.D. Mann and E.B. Andrews © 2002 John Wiley & Sons, Ltd ISBN: 0-471-49441-0

pre-licensing stage in support of a marketing authorisation application for a medicinal product, some safety hazards are only identified after wider use in the general population. The aim of establishing pharmacovigilance systems is to safeguard public health by monitoring medicinal products once authorised and by removing any from the market which are found to present an unacceptable level of risk under normal conditions of use.

The key legal requirements for pharmacovigi-lance for human use medicinal products are set out in European legislation. For medicinal products authorised under national or mutual recognition procedures, the relevant legislation is Directive 2001/83/EC of 6 November 2001 on the Community Code relating to medicinal products for human use. Directive 2001/83/EC is a codifying text, in which numerous previous Directives have been assembled into a single document. References throughout this chapter are to the codified text, as published in the Official Journal of the European Communities on 28 November 2001 and currently in force. For medicinal products authorised under the centralised procedure, the relevant legislation is Regulation (EEC) No. 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (the Agency).

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