The national pharmacovigilance systems of the Member States together form the pharmacovigilance system in the EU, co-operating in a network structure under the co-ordination of the EMEA and in liaison with the European Commission. Also included are Norway, Iceland and Liechtenstein, which are not members of the EU but are part of the European Economic Area (EEA) (EEA Joint Committee, 1999). Within this network structure all parties have their roles and responsibilities for the surveillance of medicinal products. These roles and responsibilities vary depending on the route of marketing authorisation of the product in the EU and are defined in Directive 2001/83/EC and Council Regulation (EEC) No. 2309/93. These are described in guidance documents which were developed during the 1990s for competent authorities and marketing authorisation holders in consultation with Member States and interested parties (Table 14.3). These guidelines are in accordance with recommendations

Table 14.3. Guidance documents developed by the regulatory pharmacovigilance system of the European Union at Community level (European Commission, 2001).

• Procedure for Competent Authorities on the Undertaking of Pharmacovigilance Activities m Rapid Alert System (RAS) and Non-Urgent Information

System (NUIS) in Human Pharmacovigilance m Conduct of Pharmacovigilance for Centrally

Authorised Products m Crisis Management Plan regarding Centrally

Authorised Products for Human Use m Conduct of Pharmacovigilance for Medicinal Products Authorised Through the Mutual Recognition Procedure m Standard Operating Procedure (SOP) on Referrals in accordance with the Provisions of Council Directive 75/319/EEC in the case of Safety Concerns related to Medicinal Products Marketed in the European Union m Principles of Providing the World Health Organisation with Pharmacovigilance Information m Notice to Marketing Authorisation Holders m Note for Guidance on Electronic Exchange of Pharmacovigilance Information for Human and Veterinary Medicinal Products in the European Union

Explanatory note: This constitutes an updated list as of time of going to press. These guidance documents are subject to continuous review and revised documents are announced for publication by the European Commission.

agreed at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). They have been revised in the light of experience and are available in a compiled format (European Commission, 2001).

The EMEA is a Community Agency, i.e. a public authority of the EU set up by a Community act of secondary legislation (Council Regulation (EEC) No. 2309/93) with its own legal personality (Bodies of the European Union, 2000). The objective of the EMEA is the protection and promotion of human and animal health in the EU by fulfilling, inter alia, the following tasks with respect to human medicines:

* the co-ordination of the scientific evaluation of the safety, quality and efficacy of medicinal products that have been applied for a central marketing authorisation with the aim of facilitating the access to effective and safe innovative medicinal products throughout the EU; and

* the co-ordination of post-authorisation safety of medicinal products through the pharmaco-vigilance network.

The EMEA pools scientific expertise from the Member States for the evaluation of medicinal products, and to provide advice on drug research and development programmes (European Agency for the Evaluation of Medicinal Products, 2001). More specific to pharmacovigilance, the tasks of the EMEA include the following:

* co-ordination of the supervision (including pharmacovigilance activities) of medicinal products authorised in the EU;

* provision of access to information on ADRs reported for medicinal products marketed in the EU by means of a data-processing network which can be accessed by all Member States, the EMEA and the Commission (a project known as EudraVigilance);

* maintenance of and variations to the terms of the marketing authorisation for centrally authorised products;

* management of referral procedures for nationally authorised products leading to Commission

Decisions binding in all Member States when there is a safety concern which impacts on public health in the Community; and * provision of recommendations on measures necessary to ensure safe and effective use of these products.

Much of the work of the EMEA is done within its scientific committees. For medicines used in humans this is the CPMP. This committee is supported by several expert working parties, one of which is the PhVWP. The PhVWP currently meets eight times per year at the EMEA and provides a forum for scientific discussion of product and product-class-related safety issues leading to recommendations on harmonised and synchronised action. These are ultimately implemented either by the European Commission following a CPMP Opinion for centrally authorised products, or by national competent authorities. The PhVWP also takes the lead in the development of pharmacovigilance guidelines.

In order to facilitate, in addition, a continuous exchange of information between regulators in the EEA, in particular with regard to changes in the benefit-risk balance possibly requiring major regulatory action, but also for signal evaluation, the so-called Rapid Alert-NonUrgent Information System has been established. Records of this information flow are maintained centrally by the EMEA and followed up by the PhVWP at each of their meetings. The principles and procedures of this system are presented in a Note for Guidance (European Commission, 2001, Part I, Chapter 2.1). Guidance for the electronic submission of case reports on ADRs in relation to medicinal products authorised in the EU is provided (European Commission, 2001, Part III).

Pharmaceutical companies holding marketing authorisations in the EU have various obligations in the area of pharmacovigilance which are laid down in Title IX of Directive 2001/83/EC and Council Regulation (EEC) No. 2309/93 and elaborated further in guidelines (European Commission, 2001). In particular, marketing authorisation holders must employ a qualified person who is responsible for:

* establishing and maintaining a system that collects and collates all suspected adverse reactions;

* the preparation of periodic safety update reports; and

* responding to requests for additional information from competent authorities.

In addition, marketing authorisation holders are obliged to report serious suspected adverse reactions in accordance with the legislation and guidance cited above to competent authorities within 15 days ("expedited reports'').

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