Marketing Authorization Application

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Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking 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 Commission. In the United States, the equivalent process is called New Drug Application.

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References[edit]

  1. ^ "Apply for a licence to market a medicine in the UK - GOV.UK". www.mhra.gov.uk.