Pharmaceutical Regulatory Authority definition

Pharmaceutical Regulatory Authority means, with respect to any regulatory jurisdiction, any national, federal, supranational, regional, state, provincial or local governmental or regulatory authority, agency, department, bureau, commission, council or other Governmental Entity, including the FDA and EMA, regulating or otherwise exercising authority with respect to pharmaceutical products in such regulatory jurisdiction;
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Examples of Pharmaceutical Regulatory Authority in a sentence

  • Except as otherwise contemplated by this Section 7.8 or Section 9.3(b), Acorda will have the sole responsibility and authority for filing all documents with all Pharmaceutical Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Pharmaceutical Regulatory Authority approval for the incorporation into Marketed Product to be marketed, distributed and sold in the Territory of Supplied Product to be Manufactured hereunder.

  • Notwithstanding the other provisions of this Section 7.8, Manufacturer will be responsible for obtaining and maintaining, at all times during the Term, all approvals, permits, licenses, registrations, DUNS number, authorizations, or qualifications required from any Authority (including any Pharmaceutical Regulatory Authority) required in order for it to operate in all respects the Manufacturing Site in order to conduct the Manufacturing Services as contemplated herein.

  • Manufacturer shall reasonably assist Acorda to obtain and maintain (i) Marketing Authorizations for the marketing, distribution, and sale of Marketed Product throughout the Territory and (ii) Pharmaceutical Regulatory Authority approval for the incorporation into Marketed Product for marketing, distribution, and sale of Marketed Product in the Territory of Supplied Product to be Manufactured hereunder.

Related to Pharmaceutical Regulatory Authority

  • 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;

  • Regulatory Authority means any applicable supranational, national, regional, state or local regulatory agency, department, bureau, commission, counsel, or other government entity involved in granting of Regulatory Approval for a Licensed Product in a regulatory jurisdiction within the Territory, including the FDA and the EMEA.

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

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

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;

  • Regulatory Authorities means the Commissions and the Exchange;

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • securities regulatory authority or “SRA” means a body created by statute in any Canadian or foreign jurisdiction to administer securities law, regulation and policy (e.g. securities commission), but does not include an exchange or other self regulatory entity;

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • MHLW means the Japanese Ministry of Health, Labor and Welfare, or a successor agency thereto.

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

  • New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

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

  • Regulatory Agency means any federal or state agency charged with the supervision or regulation of depository institutions or holding companies of depository institutions, or engaged in the insurance of depository institution deposits, or any court, administrative agency or commission or other authority, body or agency having supervisory or regulatory authority with respect to the Company, the Bank or any of their Subsidiaries.

  • Applicable Insurance Regulatory Authority means the insurance department or similar insurance regulatory or administrative authority or agency of the jurisdiction in which the Company is domiciled.