Regulatory exclusivities for medicinal products for human use in the EU

摘要

The placing on the market of medicinal products for human use in the EU is strictly regulated and harmonized by Regulation (EC) number 726/2004 and Directive 2001/83/ EC . The main objective of this legislation is the protection of public health and therefore the key principle is that no medicinal product may be placed on the market before the quality, safety and efficacy of the product has been assessed and approved by the competent authorities in a marketing authorization procedure. A marketing authorization is granted on the basis of an application dossier containing extensive data, including clinical research data, to document and demonstrate the quality, safety and efficacy of the medicinal product under evaluation.