How to register a medicinal product in Europe?
In Europe, no medicinal product may be placed on the market unless a Marketing Authorization (MA) has been issued by the competent authorities of that European Member State in accordance with Directive2001/83/CE by the European Medicines Agency (EMA), and Regulation (EC) No 726/2004. The authorities who can issue the MA depend upon the type of registration procedure:
- Mutual-Recognition Procedure (MRP): this procedure is based on the principle that a medicinal product has already been authorized in one EU country which will act as Referential Management Service (RMS) and it can be registered in other member states involved in the procedure which will act as CMCs.
- Decentralized Procedure (DCP): this procedure is used when a pharmaceutical company would simultaneously obtain a marketing authorization for a medicinal product in several European countries where the product has not yet been registered. The company has to choose a RMS for the procedure between the countries involved in the procedure itself.
- Centralized Procedure (CP): this procedure is a single marketing authorization application submitted to the EMA which allows the MA to become valid in all the countries in the European Union (EU) and European Economic Area (EEA). It is mandatory for certain types of medicinal products, including those derived from biotechnology, advanced therapies (such as gene and cell therapies), and orphan medicinal products intended for the treatment of rare diseases.