Regulatory Application definition

Regulatory Application means any regulatory application or any other application for marketing approval for a Product, which Newco will file in any country of the Territory, including any supplements or amendments thereto.

Regulatory Application means a regulatory application or other application (including any supplements or amendments thereto) required to be filed or filed with a Regulatory Authority in a country in connection with the Commercialization of a pharmaceutical product in such country.

Regulatory Application means the applications submitted by Noven to the FDA seeking approval for the development, manufacture, testing, storage, transport, marketing, advertisement, promotion, sale, use, distribution or other disposal of the Product in all or any portion of the Territory, including the Product ANDA.

Examples of Regulatory Application in a sentence

• PREVIOUS HOME ADDRESS INFORMATION City of Glendale Special Regulatory Application Page 1 SECTION IV.

• LICENSE AND PERMIT INFORMATION Please list licenses/permits issued to you relating to a Special Regulatory or an Adult Business License:License:Jurisdiction:Date:License:Jurisdiction:Date: City of Glendale Special Regulatory Application Page 2 5850 W.

• See U.S. EPA, (1991), Guideline for Regulatory Application of the Urban Airshed Model, EPA–450/4–91–013, (July 1991).

• The Sponsor of the Regulatory Application to FDA (as the terms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20) has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory Application.

• U.S. EPA, (1991), Guideline for Regulatory Application of the Urban Airshed Model, EPA–450/4–91–013, (July 1991).

More Definitions of Regulatory Application

Regulatory Application means any application necessary and appropriate to obtain a Regulatory Approval, including, without limitation, all required documents, data and information concerning, filed or required to be filed, or otherwise submitted by either Party to a Governmental Authority in connection with obtaining such Regulatory Approval.

Regulatory Application has the meaning provided in Section 5.1(c).

Regulatory Application means any application or filing for a Regulatory Approval, including without limitation any Investigational New Drug (IND) application, Biologic License Application (BLA), or New Drug Application (NDA).

Regulatory Application means any application required to be filed with the applicable government regulatory authority or agency of a country to test, use, market, or distribute the Product or any Improved Product or New Product for human or veterinary use, and any amendment to any of the foregoing.

Regulatory Application means any regulatory application or any other application for Regulatory Approval, which Zogenix will file in the Territory, including any supplements or amendments thereto.

Regulatory Application means any regulatory application or any other application for marketing approval for the Licensed Product, which Licensee will file in the Territory, including any supplements or amendments thereto which Licensee may file.

Regulatory Application means investigational new drug application (IND), investigational device exemption (IDE), new drug application (NDA), biologics license application (BLA), premarket approval application (PMA), or 510(k) pre-market notification filing, 510(k), or another regulatory filing submitted to the US Food and Drug Administration (FDA) related to a product or an analogous foreign filing. The related terms, “sponsor” and “applicant,” are used herein consistent with the definitions and/or usage found in 21 CFR §§3.2(c), 312.3, 600.3(t), 812.3(n), 812 Subpart C, and 814.20.