The concept of pharmacovigilance was introduced into the legislation of the EU in 1993 through a Council Directive (Council Directive 93/39/EEC amending Council Directive 75/319/EEC). EU medicines legislation has since been codified into a single Directive (2001/83/EC) in which pharmacovigilance is covered in Title IX (Articles 101 — 108). Council Directives have the objective of harmonising the national legislation of the Member States of the EU, and Member States are bound to implement these legal provisions into their national legislation. However, pharmaco-vigilance systems already existed in most Member States. These vary according to differences in historical development and the organisation of the national healthcare systems. Table 14.2 summarises the organisational features of these national systems. All are an integral part of the respective national drug regulatory agency except in Luxembourg (for which spontaneous reports are submitted to one of the French regional centres). Through the EU legislation their activities are specified with regard to medicinal products authorised for use on their territory, as follows:
* to collect information about ADRs that occur under normal conditions of use;
* to obtain information on consumption data;
* to collate information on misuse and abuse;
* to evaluate this information scientifically; and
* to ensure the adoption of appropriate regulatory decisions.
Practice has shown that pharmacovigilance needs to be conducted with a view to how the product is used in ordinary clinical practice. This includes use outside the terms of the marketing authorisation. Experience gained during the post-authorisation phase may also provide valuable input into the evaluation of medicinal products at the stage of application for marketing authorisation, if there are chemical or pharmacological similarities with authorised products.
Table 14.2. National pharmacovigilance systems in the European Union (Olsson, 1999).
Member State Year of and year of establishing the joining the national
Status of spontaneous reporting of ADR cases by health professionals
Procedure for compilation of ADR cases occurring in this Member State
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