Marketing Authorization Application definition

Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

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: (a) in the United States, a New Drug Application (as defined in Title 21, Section 314.50 et seq. of the U.S. Code of Federal Regulations or any successor regulations), including any amendment or supplement thereto, and (b) in any other country or regulatory jurisdiction, an application for regulatory approval required for marketing or sale of a Licensed Product in such country or regulatory jurisdiction, including any amendment or supplement thereto.

Examples of Marketing Authorization Application in a sentence

Marketing Authorization Application for proposed biosimilars of Pegfilgrastim, Trastuzumab and Insulin Glargine accepted for review by the European Medicines Agency.
Except (i) as may be required by law, (ii) unless explicitly requested or permitted in writing to do so by Gilead, or (iii) unless contemplated by the Master Agreement and the Ancillary Agreements, JT shall not communicate regarding any Product with any Regulatory Authority having jurisdiction in the Gilead Expanded Territory or file any IND or Marketing Authorization Application for Products in the Gilead Expanded Territory.
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.
The Board undertakes to notify Nestlé at least [**] month in advance of the commencement of the [**] month period prior to the estimated submission date of the Marketing Authorization Application in Europe, such estimate to be reasonable and made in good faith by the Board.
In the EU, the Marketing Authorization Application (MAA) for cabozantinib in advanced RCC has been accepted and granted accelerated assessment.

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 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 (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

Marketing Authorization Application means any registration or Marketing Authorization application, including any supplements or amendments thereto, such as foreign counterpart or comparable to a US New Drug Application pursuant to 21 CFR which a Party may file for the Product with the requisite Regulatory Authority in any jurisdiction.

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 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” means an application for Regulatory Approval in a country, territory or possession, including an NDA or BLA.