EU Marketing Authorisation Application (MAA)

The marketing authorization application (MAA) is a critical regulatory document required for medicinal product approval in the EU. The MAA is a comprehensive dossier that includes information on the quality, safety, and efficacy of a medicinal product, as well as information on its manufacturing and control processes. Based on the MAA, regulatory agencies can assess the ability of prospective marketing authorization holders (MAHs) to ensure and monitor a sustainable benefit/risk ratio. The MAA must comply with EU regulations and guidelines issued by the European Medicines Agency (EMA). A medicinal product can only be placed on the European Economic Area (EEA) market after marketing authorization from the relevant authorities.