Pharmaceutical Regulatory Affairs: Open Access

The centralized registration procedure allows medicinal products to be prescribed and sold in all 27 Member States of the European Community. The aim of this article is to shed light on the complex rules governing the grant of marketing authorization at the European Commission level.

The ‘Decision Making Process’ surrounding the Commission is not well understood because during the review of a new marketing authorization application the focus is on the scientific evaluation carried out by the European Medicines Agency (EMA). However, after receipt of a positive opinion by the EMA the subsequent approval process is not purely an administrative act. Knowledge of the scope, sequence of procedural steps and associated timelines at the Commission is key for accurate project planning which in turn is a prerequisite for timely product launch.