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.
Marketing Authorization Application means an application for Regulatory Approval for a Product in a country or region of the Territory.
Marketing Authorization Application means an application to the appropriate Regulatory Authority for Marketing Approval (but excluding pricing approval) in the Field in any particular jurisdiction (including, without limitation, a New Drug Application in the U.S.) and all amendments and supplements thereto.
Examples of Marketing Authorization Application in a sentence
PACKAGE 3 Package 3 shall include: Marketing Authorization Application dossier Sections II-V (named as per ICH guidelines) – including summaries and quality, non-clinical and clinical information data packages as required by the National Regulatory Authority where the dossier was submitted.
More Definitions of Marketing Authorization Application
Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to market a Product (but excluding Pricing Approval) in any particular jurisdiction, including an NDA in the U.S.
Marketing Authorization Application or “MAA” shall mean an application for Regulatory Approval (but excluding Price Approvals), including without limitation an NDA filed in the United States. For clarity, Marketing Authorization Applications shall exclude INDs.
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” shall mean an application for Regulatory Approval in the European Union to market a product in any country, whether filed with the EMA under the centralized EMA filing procedure or a Regulatory Authority in any country in the European Union.
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 means a marketing authorization application submitted to the EMA or any other applicable Governmental Entity of one of the EMA member states.