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.
^"Apply for a licence to market a medicine in the UK - GOV.UK". www.mhra.gov.uk.
^"Marketing Authorisation - European Medicines Agency".
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MarketingAuthorisationApplication (MAA) is an application submitted by a drug manufacturer seeking marketingauthorisation, that is permission to bring...
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PMID 18846056. S2CID 74421879. "Advexin: Withdrawal of the marketingauthorisationapplication". European Medicines Agency. 11 February 2009. Retrieved...
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original marketingauthorisation holder relating to (pre-) clinical testing is protected. Accordingly, in relation to marketingauthorisationapplications submitted...
1016/0016-5085(94)90538-x. PMID 7523224. "Takeda Submits MarketingAuthorisationApplication for Vedolizumab in Moderately to Severely Active Ulcerative...
of the MAH. Each company (i.e. Applicant/MarketingAuthorisation Holder or group of MarketingAuthorisation Holders using a common pharmacovigilance system)...
legally binding character of European Pharmacopoeia texts for MarketingAuthorisationApplications (MAA). All manufacturers of medicines or substances for pharmaceutical...
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marketingauthorisations are recommended for suspension and marketingauthorisationapplications which do not satisfy the criteria for authorisation as...
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risk assessment (ERA) procedure (to be supplied for the marketingauthorisationapplication) and are highlighted as potential sources of bioaccumulation...
prove its quality, safety and efficacy. This helps to obtain a MarketingAuthorisation grant. "Guideline for Drug Master Files". US Food and Drug Administration...
European Union. The Directive requires all covered AIFMs to obtain authorisation, and make various disclosures as a condition of operation. It followed...
2015. "Johnson & Johnson Announces Submission of European MarketingAuthorisationApplications for Janssen's Investigational Ebola Vaccine Regimen". Janssen...
In-PharmaTechnologist. "Questions and answers on the withdrawal of the marketingauthorisationapplication for Mersarex (iclaprim)" (PDF). EMA. 19 November 2009. "Privately...
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