Martens, Marc; Carbonnelle, Nicolas --- "THE EU REGULATORY FRAMEWORK FOR MEDICINAL PRODUCTS FOR HUMAN USE" [2019] ELECD 1279; in Figueroa, Pablo; Guerrero, Alejandro (eds), "EU Law of Competition and Trade in the Pharmaceutical Sector" (Edward Elgar Publishing, 2019) 503

Book Title: EU Law of Competition and Trade in the Pharmaceutical Sector

Editor(s): Figueroa, Pablo; Guerrero, Alejandro

Publisher: Edward Elgar Publishing

Section: Chapter 13

Section Title: THE EU REGULATORY FRAMEWORK FOR MEDICINAL PRODUCTS FOR HUMAN USE

Author(s): Martens, Marc; Carbonnelle, Nicolas

Number of pages: 49

Abstract/Description:

The chapter provides a general introduction to the European regulatory framework applicable to medicinal products for human use. It describes the acquis communautaire in the field of human medicines regulations, including the rules on market access procedures and requirements. The chapter features an overview of the different regulatory categories of medicinal products and the regulatory data protection regimes that are in place.