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...
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of the MAH. Each company (i.e. Applicant/MarketingAuthorisation Holder or group of MarketingAuthorisation Holders using a common pharmacovigilance system)...
now (2024.01.19) "EMA starts review of conditional marketing authorisationapplication for Skycovion COVID-19 vaccine". European Medicines Agency (EMA)...
legally binding character of European Pharmacopoeia texts for MarketingAuthorisationApplications (MAA). All manufacturers of medicines or substances for pharmaceutical...
this legislation, all applications for marketingauthorisation of new medicinal products, or variations to existing authorisations, have to either include...
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...
were marketed prior to the date(s) of the MarketingAuthorisation(s) (MA(s)) specified in the SPC application. This is because the ECJ's rulings in C-195/09...
19 June 2007 Guideline on Excipients in the Dossier for Application for MarketingAuthorisation of a Medicinal Product Directive 94/36/EC - European Commission...
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