[The development of regulation of pharmaceuticals turn-over in EU and the USA in 1992-2020. Report 3. The making of the EU legislation of pharmaceuticals turn-over in 2001-2020].

Abstract

This article proceeds the topic of the article "The development of regulation of the circulation of medicines in the EU and the USA in 1992-2020." The history of development of European pharmaceutical legislation in 2001-2020 is considered. The acts of indirect action adopted by EU Parliament at first stage of development of legislation concerning medications failed to fully harmonize normative base of the EU Member States in pharmaceutical market. Since 2000, the EU Parliament and the EU Council adopt laws of direct action - the Regulations. Alongside with the pharmaceutical Code, the Regulations for single segments of pharmaceutical market constituted set of laws related to turn-over of medications. The legislators, at developing EU laws, took into account the US regulatory standards. Despite differences in history, legislative traditions and structure, regulatory systems of the USA and the EU concerning medications turn-over were basically harmonized.