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The Single European Act was adopted in 1987 to create a European Market without internal frontiers to promote the free movement of goods, services, capital, and people. The new legislation for Marketing Authorizations in the European Union was created to further these goals of the single market. The legislation has created a European Agency for the Evaluation of Medicinal Products (EMEA) and there will be three procedures for registration of products: the centralized, decentralized, and national procedures. These new procedures will change the process of obtaining marketing authorizations in Europe in a dramatic way and will have a significant impact on the Regulatory Affairs strategy and functions within the pharmaceutical industry and national Regulatory Agencies. |
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The two previous European approval systems, the concertation procedure [1] and the multistate procedure [2,3], have provided experience on which to build the new procedures. A critical difference between these and the new procedures, however, is that decisions from these two procedures were not binding on national Member States resulting in differing decisions, whereas in the new systems the decisions are binding. Thus, as we move through the transition and national procedures have a more limited role, we will have evolved into a truly European approval process. This chapter will explain the role of some of the main bodies involved in the new system, the procedures themselves, and the impact this will have on regulatory strategies in development of new products. |
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II. The Legislation and Implementation Dates |
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The legislation underpinning the future marketing authorization systems in the European Community takes the shape of a Regulation and three Directives for human and veterinary medicinal products. Regulation 2309/93 of 22.7.93 [4] sets out arrangements for a European Agency for the Evaluation of Medicinal Products (EMEA) and for the new centralized procedure that will lead to a community authorization valid in all 12 Member States. Directive 93/39/EEC of 14.6.93 [5] amends earlier Directives 65/65 [6], 75/318 [7], and 75/319 [8] and sets out the decentralized procedure for human medicinal products that, based on the principle of mutual recognition, will allow extension of approval in one Member States to others. This procedure is also called the mutual recognition procedure. The second Directive 93/41/EEC of 14.6.93 [9] repeals the original Directive 87/22/EEC [1], which set up the concertation procedure. A third Directive 93/40/EEC [10] sets out the decentralized procedure for vet- |
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