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 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.

Examples of Approval Application in a sentence

• The submission must be prepared by a Registered Surveyor, must be in accordance with the City of Sydney's Public Domain Manual and must be submitted with a completed Alignment Levels checklist (available in the Public Domain Manual) and Footpath Levels and Gradients Approval Application form (available on the City’s website).

• 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.

• The bank shall examine the documents (other than the Supplier’s Certificate and the Commodity Approval Application) to be submitted to USAID in accordance with good commercial practice to de- termine whether such documents com- ply with the requirements of para- graphs (b) (1) through (7) of this section in the following particulars, and no other.

• One signed original of the Commodity Approval Application executed by the commodity supplier and countersigned by USAID.

More Definitions of Approval Application

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.

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 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.

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