Regulatory Scheme definition

Regulatory Scheme means the United States Public Health Service Act and the regulations, interpretations and guidelines promulgated thereunder by the FDA or the regulatory scheme applicable to the Collaboration Products in any country other than the United States, as such statutes, regulations, interpretations and guidelines or regulatory schemes may be amended from time to time.
Sample 1Sample 2Sample 3
Regulatory Scheme means the U.S. Food, Drug and Cosmetics Act and the regulations, interpretations and guidelines promulgated thereunder by the FDA or the regulatory scheme applicable to Aldurazyme in any country other than the United States, as such statutes, regulations, interpretations and guidelines or regulatory schemes may be amended from time to time.
Sample 1Sample 2Sample 3
Regulatory Scheme means the United States Public Health Service Act, the United States Food, Drug and Cosmetics Act, and the regulations, interpretations and guidelines promulgated thereunder by the FDA or the regulatory scheme applicable to the Collaboration Products in any country other than the United States, as such statutes, regulations, interpretations and guidelines or regulatory schemes may be amended from time to time.
Sample 1Sample 2Sample 3

Examples of Regulatory Scheme in a sentence

  • In Defense of a Private Regulatory Scheme for Policing Cloud Computing.

  • The following are the highlights of the ASEAN Harmonized Cosmetic Regulatory Scheme Common Technical Documents.

  • Those basic market principles all but compel the conclusion that syndicated term loans are not securities.D. The Regulatory Scheme Reflects The Understanding That Syndicated Term Loans Are Not SecuritiesThe current regulatory regime also reflects the understanding that syndicated term loans are not securities.

  • As a result of this collaboration, the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) was signed on 2 September 2003.

  • The ASEAN Harmonized Cosmetic Regulatory Scheme is the agreed one standard scheme for regulating cosmetic products among the ASEAN countries.

  • All cosmetic products manufactured in or imported from non-ASEAN Member countries or ASEAN Member Countries have to comply with the ASEAN Harmonized Cosmetic Regulatory Scheme and its technical documents.

  • Greenberg, Dietary Supplements Caught in Murky Regulatory Scheme, Chicago Daily Law Bulletin, vol.

  • New York State’s Regulatory Scheme for the Employment of School Bus Drivers New York State laws and regulations promulgated under them provide a comprehensive system regulating the employment of bus drivers and, in particular, school bus drivers.

  • REDOIL Petitioners Mischaracterize the Title V Regulatory Scheme REDOIL Petitioners’ notion that “applicable increment requirements” in section 504(e) mean “applicable to the area” rather than “applicable to the source” is not supported by the Title V regulatory model as a whole.

  • The Independent Monitor for the Press CIC Regulatory Scheme This scheme describes how IMPRESS will exercise the regulatory functions and powers conferred on it under the Articles.


More Definitions of Regulatory Scheme

Regulatory Scheme means the scheme established by the Company
Sample 1Sample 2Sample 3
Regulatory Scheme means any regulatory scheme promulgated by a Regulatory Authority applicable to the Products in any country in the Territory, as such statutes, regulations, interpretations and guidelines or regulatory schemes that may be amended from time to time, including, without limitation, the statutes, regulations, interpretations, and guidelines administered by the FDA.
Sample 1Sample 2
Regulatory Scheme means the United States Federal Food, Drug and Cosmetic Act and the regulations, interpretations and guidelines promulgated under that Act by the FDA or the corresponding regulatory scheme applicable to the Collaboration Product in any country other than the United States, as such statutes, regulations, interpretations and guidelines or corresponding regulatory schemes may be amended from time to time.
Sample 1

Related to Regulatory Scheme

  • Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • Regulatory Authority means, with respect to any national, supra-national, regional, state or local regulatory jurisdiction, any agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such jurisdiction.

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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 set out in Schedule C hereto;

  • Bank Regulator means any federal or state banking regulator, including but not limited to the FDIC, the NJDOBI, and the FRB, which regulates Somerset Bank or Regal Bank, or any of their respective holding companies or subsidiaries, as the case may be.

  • 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.

  • 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.

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • 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.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • 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.

  • Regulatory Rules means all corporate and securities laws, regulations, rules, policies, notices, instruments and other orders of any kind whatsoever which may, from time to time, apply to the implementation, operation or amendment of this Plan or the Options granted from time to time hereunder including, without limitation, those of the applicable Regulatory Authorities.

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • EMA means the European Medicines Agency or any successor agency thereto.

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

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Signing Authority means an officer or agent of the organization with written authorization to commit the legal entity to a binding agreement.

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to 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).

  • MHLW means the Ministry of Health, Labour and Welfare of Japan, or the successor thereto.

  • 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;