ABSTRACT
The European Community was established by the Treaty of Rome in 1957. The European Community changed its name to the European Union (EU) in 1992. Currently, there are 15 member states: Austria, Belgium, Denmark, Ireland, Finland, France, Germany, Greece, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden and the UK, sharing 11 official lan guages. Additional countries seeking to join the EU include Estonia, Hungary, Poland, Slovenia and the Czech Republic. The influences of the Treaty of Rome still guide much of the current legislation in the EU regarding the free movement of goods, persons, services and capital, the main tenance of fair competition and the co-ordination of national economic policies. In 1995, two approval procedures for medicinal products were established in the spirit of this Treaty: the Mutual Recognition and the Centralized Procedures. Developed because of the desire for rapid and consistent recognition of approvals within the EU and in order to ensure that innovative drugs of high interest become available to the whole EU simultaneously, these initiatives represent a sig nificant step towards uniform national approval timelines, which could previously vary from 1 year to over 4 years.
