[The development of regulation of pharmaceuticals turn-over in EU and the USA in 1992-2020. Report 2. Development of normative legal base of pharmaceuticals turn-over in EU in 1992-2001].

Abstract

The article continues to consider problem of regulation of pharmaceuticals turn-over in the EU and the USA in 1992-2020. The history of development of European pharmaceutical legislation in 1992-2001 is considered. This stage is characterized by passing Directives (laws of indirect action) that were obligatory for implementation through their inclusion into national normative legal bases. In 2001 the passed laws were compiled into EU Pharmaceutical Code (Directive 2001/83) that regulates main sections of pharmaceuticals turn-over from their production to pharmaceutical control. The adoption of Code laid the foundation for EU legislation in the field of medications.