ABSTRACT
I. INTRODUCTION 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 prod ucts: the centralized, decentralized, and national procedures. These new pro cedures will change the process of obtaining marketing authorizations in Eur ope 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.
