Chapter 3 - Marketing authorization and licensing of medicinal products in EU: Regulatory aspects

Abstract

In this chapter the concept, requirements and process for licensing and marketing authorisation of medicinal products containing chemical entity of the drug substance in the European Union (EU), are presented. The governing bodies and their role, the legal framework, rules and guidelines are explained. Further, the role and responsibility of the marketing authorisation holder to ensure compliance with the rules in effect at the time of submission and throughout the life cycle of the product whilst it is licensed are presented. Procedures followed, and compliance with the requirements dictating the strategy of marketing of the medicinal product in the EU and level of penetration envisaged is discussed. Further rules for variation and extension of the license of medicinal products are highlighted.