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.
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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.
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Regulatory Scheme means the scheme established by the Company
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Examples of Regulatory Scheme in a sentence

  • Flashing Road Traffic Signals shall be aligned to provide the drivers of road vehicles with the maximum possible warning of the stop indication commensurate with the road speed limit approaching and over the level crossing.

  • 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.

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

  • 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.

  • 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.

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

  • Free, prior and informed consent (or consultation) “requires actors to solicit and obtain the consent of indigenous communities prior to undertaking projects that may impact their territories or resources.” Julian Aguon & Julie Hunter, Second Wave Due Diligence: The Case for Incorporating Free, Prior, and Informed Consent into the Deep Sea Mining Regulatory Scheme, 38 STAN.

  • Except to the extent prohibited by the Regulatory Scheme, the Parties agree to assign to Kallikrein LLC on the LLC Formation Date any "Orphan Drug" designations for any Collaboration Product which Dyax or Genzyme may receive during the term of this Agreement.

  • If requested by any such entity, the Company may permit participation in the Regulatory Scheme for the purpose of using the Arbitration Service only.


More Definitions of Regulatory Scheme

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.
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Regulatory Scheme means the United States Food, Drug and Cosmetic Act and 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, including, without limitation, the statutes, regulations, interpretations, and guidelines administered by the FDA and the EMEA.
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Related to Regulatory Scheme

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining 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.

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory.

  • 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 as 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 and any successor agency thereto.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • 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 means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

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

  • 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 Japanese Ministry of Health, Labour and Welfare, and any successor agency 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;