Application for Regulatory Approval definition

Application for Regulatory Approval means each application in a form accepted for filing by a Regulatory Authority to obtain Regulatory Approval in the Territory.
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Application for Regulatory Approval means an application made to a Regulatory Authority in any country for permission to Market a pharmaceutical product in that country.
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Application for Regulatory Approval means an application made to a Regulatory Authority in any country for permission to Market a pharmaceutical product in that country, and includes a New Drug Application (an “NDA”) and an Abbreviated New Drug Application (an “ANDA”).
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Examples of Application for Regulatory Approval in a sentence

  • With respect to any NDA, supplemental NDA, or other Application for Regulatory Approval, the CDRC (and, with respect to the Chemistry, Manufacturing and Controls ("CMC") section of the NDA, and comparable sections in other Applications for Regulatory Approval in the Co- Promotion Countries, the MSC) will agree upon a separate review schedule in order to take into account the volume and scope of such submissions.


More Definitions of Application for Regulatory Approval

Application for Regulatory Approval means the foreign equivalent to an NDA in Countries of the Territory other than the United States.
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Application for Regulatory Approval means a submission made to the FDA (whether such application be in the form of an NDA, ANDA, sNDA or other similar application) or the appropriate regulatory body equivalent to the FDA in a country other than the United States in the Territory, seeking approval to market and sell a Finished Product in either the United States or such other country, respectively. "Applicable Percentages" shall have the meanings variously ascribed thereto in Sections 4.1, 4.2, and 4.3. "Approval Date" shall mean the date on which the FDA or the appropriate regulatory body equivalent to the FDA in a country in the Territory other than the United
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Application for Regulatory Approval means an application made to a Regulatory Authority for permission to Market and/or Manufacture the Product in any country in which that Regulatory Authority has jurisdiction.
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Application for Regulatory Approval means an application made to a Regulatory Authority in any country for permission to Market Licensed Product in that country, and includes without limitation a New Drug Application (an "NDA") and an Abbreviated New Drug Application (an "ANDA") submitted to the FDA or an equivalent application submitted to an equivalent Regulatory Authority in the Territory.
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Application for Regulatory Approval means any application required for the purpose of marketing or selling or using a therapeutic or prophylactic product to be filed with a governmental agency in any jurisdiction, including a New Drug Application (“NDA”) filed with the FDA or Product License Application or Marketing Authorization in the European Union.
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Application for Regulatory Approval shall have the meaning given it in the Development Agreement. "Business Day" means any day except a Saturday, Sunday or other day on which commercial banks in the City of Chicago are authorized by law to close. "Change in Control" shall mean a merger of NaPro with or into, or the sale of all or substantially all of the assets of NaPro to, any company the equity market capitalization of which is at least fifteen billion dollars ($15,000,000,000) and that is engaged primarily in the manufacture, distribution or sale of pharmaceutical or health care products. "Common Stock" shall have the meaning set forth in the Recitals to this Agreement. "Control" and the correlative terms "Controlling" and "Controlled" shall mean the power, whether or not exercised, directly or indirectly to direct the management and policies of a Person whether by contract, through the ownership of voting securities or otherwise. "Development Agreement" shall have the meaning set forth in the Recitals to this Agreement. EXECUTION COPY
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Related to Application for Regulatory Approval

  • Regulatory Approval means any and all approvals (including any applicable Pricing Approvals), licenses, registrations, or authorizations of any government agency or authority that are necessary for the marketing and sale of a Licensed Product in the relevant country or group of countries in the Territory.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.