Review 2001: The Future of European Pharmaceutical Legislation

Abstract

Following six years of use of the European procedures, Review 2001 sets out to propose changes to these systems. The preliminary remarks were recently published. They introduce changes that were agreed upon by the European Commission in July 2001, subject to further linguistic and legal verifications. These are currently working documents, not the final legislative proposals to be presented by the European Commission to the European Parliament and the council for adoption. These proposals are likely to be adopted by 2004.

This article focuses on the changes proposed for human medicinal products, with only a few remarks on veterinary medicinal products, and on certain key changes. These include changes to the Centralised Procedure, the removal of the need for renewal applications, the requirement for products to be placed on the market within two years of marketing authorization, the updated structure of the European Agency for the Evaluation of Medicinal Products, compassionate use for medicinal products, and the proposed Decentralised Procedure.