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Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X; Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5; Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828-2029-7; Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 92-828-2037-8
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.
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis
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The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
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The Energy Marketers of America is a 501(c)(6) nonprofit organization [2] that based in Washington D.C. EMA represents its members by running an annual 'Day on The Hill' event, publishing EMA Journal and operating a Political Action Committee called The EMA Small Business Committee [3] EMA holds its annual meeting each year at the National ...