Pharmaceutical Legislation 2001 Review

A major review of European pharmaceutical legislation was carried out on behalf of the Commission by independent consultants and published in October 2000. Following this, the Commission announced proposals for legislative reform in July 2001. The Commission identified seven main goals, including guaranteeing tighter surveillance of the market, in particular by strengthening pharmacovigilance procedures.

The proposed changes to existing regulatory requirements include an obligation to prepare and review periodic safety update reports more frequently than at present. After the initial two-year period, post-authorisation reports will be submitted on an annual basis for the following two (rather than three) years and at three (rather than five) yearly intervals from then on. Marketing authorisation holders will be required to use the medical terminology accepted at international level for the transmission of adverse reaction reports (as set out in Volume 9).

There will be new obligations for the Agency; it will be required to ensure the dissemination of information on adverse reactions to centrally authorised products by means of a database permanently accessible to all Member States and to distribute pharmacovigilance information to the general public. The role of the Committee for Proprietary Medicinal Products will be replaced with a newly established Committee for Human Medicinal Products, with responsibilities that specifically include pharmacovigilance. Following receipt of pharmacovigilance information concerning centrally authorised products, the Committee for Human Medicinal Products will be able to formulate opinions on the measures necessary, which may include amendments to the marketing authorisation.

The proposed amendments have been drafted as a recasting of Regulation (EEC) No. 2309/93 and as amendments to the codifying Directives 2001/83/EC (and 2001/82/EC for veterinary medicinal products). The draft legislation was sent to the European Parliament and Council on 26 November 2001. However, the amendments are unlikely to be adopted before 2003, with implementation in early 2004.

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