Approval Application definition

Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

Approval Application means a BLA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

Approval Application means an application by a radioactive waste facility regulated under this chapter or Title 19, Chapter 5, Water Quality Act, for a permit, license, registration, certification, or other authorization.

Examples of Approval Application in a sentence

• Development Approval Application (Permit) Recorded Convenant AffidavitI, the undersigned, serve as the owner and/or owner's representative and certify that the information contained herein to be true and accurate.

• Funds will only be reserved upon approval of the Pre- Approval Application form.Project Sponsor:Upon project approval, the Project Sponsor agrees to deliver energy and/or demand savings resulting from the installation of these measures at the project site.

• In connection with the Preliminary Approval Application, the Parties shall request that the Court schedule and conduct a hearing after dissemination of Class Notice, at which time it will consider whether the Settlement is fair, reasonable, and adequate pursuant to Rule 23 of the Federal Rules of Civil Procedure.

• I/we , the registered owner(s) of hereby authorize(Municipal address or legal description) to act as agent for the Site Plan Approval Application which relates to the above noted lands.

• The Parties agree that the terms of this Settlement shall remain confidential and not be disclosed by any Party until the Agreement is filed in connection with the Preliminary Approval Application.

More Definitions of Approval Application

Approval Application means an NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

Approval Application means any application necessary and appropriate to obtain a Regulatory Approval, together with all required documents, data and information concerning any Product which is the subject of such application.

Approval Application means, with respect to a Licensed Product in a particular jurisdiction, an application for approval, license, registration or authorization necessary for the Commercialization of such Licensed Product in such jurisdiction, including, with respect to the United States, an application for approval for such Licensed Product by the FDA, and with respect to the European Union, an application for approval for such Licensed Product by the European Commission.

Approval Application means the submission to the relevant Governmental Authority of an appropriate application seeking any approval (including Price Approval), registration, license or authorization from any Governmental Authority required for the manufacture, Development, Commercialization, distribution, sale, storage or transport of the Product in any country of the Territory, and shall include, without limitation, a marketing authorization application, supplementary application or variation thereof, NDA, or any equivalent applications in any country of the Territory.

Approval Application means an application by a radioactive waste facility regulated under Title 19, Chapter 3 or Title 19, Chapter 5, for a permit, permit modification, license, license amendment, or other authorization.

Approval Application means the submission to the relevant Governmental Authority of an appropriate application seeking any Approval.

Approval Application has the meaning set forth in Section 11.1(a)(i).