Final Regulatory Approval definition

Final Regulatory Approval means in relation to any Licensed Product, the approval by the regulatory authority in a given country as may be required before such Licensed Product may be sold in such country.
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Final Regulatory Approval means Regulatory Approval that allows for the immediate marketing and sale of a Licensed Product.
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Final Regulatory Approval means all approvals and master files, establishment licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the promotion, manufacture, use, storage, transport or sale of a Collaboration Product in the Territory (including NDA Approvals and approvals of Product Labeling).
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Examples of Final Regulatory Approval in a sentence

  • For a comparison of the two approaches, see M Peguera, The DMCA Safe Harbors and Their European Counterparts: A Comparative Analysis of Some Common Problems (2009) 32 Columbia JL & A 481.

  • Within five (5) business days after Final Regulatory Approval, CPTAI and EMPCo shall dismiss with prejudice their appeal in the Settled Alaska Superior Court Case.

  • With respect to those countries outside the United States in which EpiCept has obtained Final Regulatory Approval of the LidoPAIN(R) BP Product.

  • Upon Final Regulatory Approval, the challenges to the TAPS Carriers’ intrastate rates in the Settled RCA dockets shall be dismissed with prejudice and the dockets shall be terminated and closed.

  • Within thirty (30) days of Final Regulatory Approval, each of the Remaining Carriers shall file new permanent intrastate rates that are no higher than (a) $4.885 per barrel to Valdez, (b) $4.851 to Petro Star Valdez, and(c) $3.085 to GVEA, with such rates to take effect as permanent rates on the first day of the month that occurs at least thirty (30) days after the filing of the new rates.

  • Thus, the KIPO allows divisions in charge of examination on those fields to manage specific standards under the authority of Guidelines of the KIPO.

  • Fresenius GmbH shall have the right to obtain Final Regulatory Approval in all jurisdictions within the Non-U.S. Territory in its own name and, where required by applicable law, in the name of any permitted distributor or sublicensee of Fresenius GmbH, and shall own all such Final Regulatory Approvals as are issued and all submissions as are made in connection therewith.

  • The following MDT codes should be assigned: 1) MDT 2008 Devices manufactured in clean rooms and associated controlled environments, because the manufacturing of the implant is in a controlled environment, 2) MDT 2006 Devices manufactured using chemical processing, because the main risks in manufacturing are related to the testing and mixing of the components, 3) MDT 2011 Devices which require packaging, including labelling because the implant is packed and labelled.

  • Upon Final Regulatory Approval, this Stipulation shall settle with prejudice all aspects of the challenges to the TAPS Carriers’ intrastate rates that are currently pending in the Settled RCA Dockets as well as the appeal pending before the Superior Court of the State of Alaska in Case No. 3AN-16-07498CI (the “Settled Alaska Superior Court Case”).

  • Regulatory Assets Pending Final Regulatory Approval June 30, December 31, Noncurrent Regulatory Assets If these costs are ultimately determined not to be recoverable, it could reduce future net income and cash flows and impact financial condition.


More Definitions of Final Regulatory Approval

Final Regulatory Approval means the Regulatory Approval granted by a Governmental Authority after the successful completion of a Phase III Clinical Trial.
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Related to Final Regulatory Approval

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • 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.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Pricing Approval means any approval, agreement, determination, or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

  • 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.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

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

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.