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 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 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.

Examples of Approval Application in a sentence

• NOTE: If your school’s name, program title, and degree type does not appear on the approved list, please have your school complete a NP Program Approval Application (http://mbon.maryland.gov/Documents/program_approval_form.pdf) to have it added to our approved list and email it to: mbon.educationprograms@maryland.gov.

• Attached.Occupational Curriculum Approval Application PART B: Supportive Documentation and Data This part of the application is designed to document the program-to-occupational demand connection, the college’s projected enrollment, proposed curricular structure, faculty requirements, and fiscal support.

• Should the Court refuse to grant the Approval Application or refuse to approve the Agreement in whole or in part, save and except with regards to paragraphs 14, 23, 38 to 41 of the Agreement, the Agreement will be null and void and will not give rise to any right or obligation in favour of or against the Parties and the Class Members.

• Gore & Associates, Inc.1505 North Fourth Street Flagstaff, AZ 86004 U.S. Date(s) of Panel Recommendation: None Premarket Approval Application (PMA) Number: P230023 Date of FDA Notice of Approval: January 12, 2024‌Breakthrough Device: Granted breakthrough device status on October 1, 2021 because of reasonable expectation that the device can provide more effective treatment of a life threatening disease, as well as due to lack of approved or cleared endovascular device alternates.

• The Approval Application will be held on a date to be scheduled by Lynx Air and confirmed by the Court upon application by Lynx Air, who shall use its best efforts to schedule the Approval Application by no later than April 10, 2024, subject to Court availability.

More Definitions of Approval 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).

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 an NDA or similar application or submission for a pharmaceutical product to a Regulatory Authority in a country or group of countries to obtain Marketing Approval for such pharmaceutical product in that country or group of countries, including any amendment thereof.