Marketing Authorization Application definition

Examples of Marketing Authorization Application in a sentence

  • We submitted our Marketing Authorization Application (“MAA”) to the EMA on November 23, 2020, which was accepted for review on December 22, 2020, and the Biologics License Application (“BLA”) to the FDA on November 30, 2020, which was accepted for review on January 29, 2021.


More Definitions of Marketing Authorization Application

Marketing Authorization Application means an application for Regulatory Approval for a Product in a country or region of the Territory.
Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.
Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.
Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession other than the U.S.
Marketing Authorization Application or “MAA” means an application for authorization to market and/or sell a drug product submitted to a Regulatory Authority in any country or jurisdiction other than the U.S., and amendments and supplements thereto, including, with respect to the European Union, a marketing authorization application filed with the EMA pursuant to the Centralized Approval Procedure or with the applicable Regulatory Authority of a country in the European Economic Area with respect to the decentralized procedure, mutual recognition or any national approval procedure.
Marketing Authorization Application or “MAA” means a Marketing Authorization Application, Biologics License Application or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, to obtain marketing approval for a pharmaceutical or diagnostic product, in a country or in a group of countries.