Marketing Authorization Application definition

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 an application for Regulatory Approval for a Product in a country or region of the Territory.

Marketing Authorization Application or “MAA” means any new drug application, biologics license application, or other marketing authorization application, in each case, filed with the applicable Regulatory Authority in a country or other regulatory jurisdiction, which application is required to commercially market or sell a pharmaceutical or biologic product in such country or jurisdiction (and any amendments thereto). In the context of imported drugs, MAA is also known as the Import Drug License (“IDL”) application.

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.

• In the EU, the Marketing Authorization Application (MAA) for cabozantinib in advanced RCC has been accepted and granted accelerated assessment.

• 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.

More Definitions of Marketing Authorization Application

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 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 a marketing authorization application submitted to the EMA or any other applicable Governmental Entity of one of the EMA member states.

Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell any product [**] in any particular country or regulatory jurisdiction, including any (a) Biologics License Application submitted under Section 351(a) of the PHSA, (b) New Drug Application submitted under Section 505 of the FD&C Act, or (c) substantially similar application or submission filed with a Regulatory Authority in a country or group of countries within the Territory to obtain Product Approval to Commercialize such product in that country or in that group of countries.

Marketing Authorization Application or “MAA” shall mean an application for Regulatory Approval (but excluding Price Approvals) required for marketing of pharmaceutical product. Solely as used in Section 8.2, “MAA” shall mean the application for Regulatory Approval (but excluding Price Approvals) required for marketing of the first Product in the EU.

Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to market the Product (but excluding pricing approval) in any particular jurisdiction.

Marketing Authorization Application or “MAA” means an application for Regulatory Approval in the Licensed Territory, including a Biologics License Application as described in 21 C.F.R. §601.2, as amended.