The European Union (EU) unifies 28 Member States as well as countries in the European Economic Area (EEA), providing a single market for the pharmaceutical industry. The EU’s directives and regulations outline the requirements for the development, manufacture and marketing of medicinal products for human and veterinary use. These requirements are distinct from those for development and authorisation of medical devices and in vitro diagnostics in the EU. High standards of quality, safety and efficacy have to be met in order for a product to be granted a Marketing Authorisation (MA). The European Medicines Agency (EMA) is a decentralised organisation responsible for the scientific evaluation of EU Marketing Authorisation Applications for human and veterinary medicines through the Centralised Procedure. Within individual Member States, designated Competent Authorities assess marketing applications and monitor compliance for medicinal products submitted under the Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and National Procedure (NP).
This course provides an overview of the regulations and legislative framework, as well as the EMA entities responsible for medicinal product reviews. The different application and registration procedures are described, followed by an explanation of the regulatory requirements for a product’s lifecycle, including marketing and postmarketing requirements, and prescription to over-the-counter (OTC) switches. The enforcement of regulations through inspections and other compliance activities is also addressed.