Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
MAA is part of the official procedure before the Medicines and Healthcare products Regulatory Agency in the United Kingdom[1] and the Committee for Medicinal Products for Human Use of the European Medicines Agency, a specialised agency of the European Commission. A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein.[2] In the United States, the equivalent process is called New Drug Application.
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This page was last edited on 8 July 2023, at 19:03