The Centralised Procedure is a European licensing procedure which leads to a centrally authorised product with a single marketing authorisation. The evaluation process is coordinated by the European Medicines Agency (EMA) using experts from the Member States. The marketing authorisation is issued by the European Commission upon request by the European Medicines Agency (EMA) and following an opinion from the Committee on Human Medicines (CHMP).
The centralised procedure is mandatory for certain products and optional for others. Certain medicinal products are not eligible for the centralised procedure. The procedure is mandatory for biotechnology products, high-technology products, orphan medicines and products containing new substances for indications such as acquired immunodeficiency syndrome, cancer, neurodegenerative disorders, diabetes, autoimmune diseases and immunodeficiency and viral infections.
More information about EMA and the centralised procedure is available at: www.ema.europa.eu