Regulatory Authorisations definition

Regulatory Authorisations means all marketing authorisations, approvals, clearances and authorisations that may be required by a Regulatory Authority in any country or region within the Territory prior to Phase II Clinical Trial Commencement and/or Phase III Clinical Trial Commencement and/or commercial sale of the Licensed Product, including any necessary variations thereto, but excluding always any Price Approvals.
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Regulatory Authorisations means all authorisations, approvals, clearances, and licences of a Competent Authority (including an NDA) that may be required in any country of the Territory prior to commercial sale of the relevant Licensed Product in the Field, including any necessary variations thereto, but excluding any Price Approvals.
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Regulatory Authorisations means all marketing authorisations, approvals, clearances and authorisations that may be
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Examples of Regulatory Authorisations in a sentence

  • Based on this assessment, recommendations will be made to improve future trips and visits.

  • For properties registered under Section 34.44(2), the Creditor is not required to renew the registration when, before the expiration of one year from the date of registration or renewal, the foreclosure action is dismissed, or the property is transferred to an unaffiliated third party.

  • The term, “Clinical Trial”, includes any pre-clinical studies the Charity performs in support of that clinical trial which are either necessary (to comply with Regulatory Authorisations or applicable law) or are approved from time to time by the JPT.

  • Artificial turf shall not be visible from the street or golf course and must be submitted to the ARB for approval.

  • Regulatory Authorisations means any approval, authorisation, consent, declaration, licence, exemption, authorisation, notarisation, permit or waiver, however it is described, issued or granted by a Regulatory Authority, including any renewal or amendment and any condition imposed by a Regulatory Authority, and includes in the case of Target, the Key Permits.

  • If a firm has any doubts about the fit and proper status of any of its principals or employees, it should contact the Regulatory Authorisations Department (+44 (0) 131 347 0282) for advice.

  • Regulatory Authorisations means, depending on the nature of the Investors’ applications, any approval, permits, licences, registrations and all other authorisations necessary for the Investors’ activities within the Zone, in accordance with the laws of the Republic of Benin.

  • Please contact Regulatory Authorisations if you wish to discuss this further.


More Definitions of Regulatory Authorisations

Regulatory Authorisations means all authorisations, approvals and clearances that may be required by a Regulatory Authority in any country or region in the Territory before (as the context may require) Phase II Clinical Trial Commencement or Phase III Clinical Trial Commencement or commercial sale of the Agent Product or the Collaboration Product. Price Approvals are not Regulatory Authorisations;
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Regulatory Authorisations means all authorisations, approvals, clearances, and licences of a Competent Authority that may be required in any country of the Territory prior to commercial sale of the relevant Product in the Field, including any necessary variations thereto, but excluding any Price Approvals.9.
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Regulatory Authorisations means any and all Marketing Authorisations, licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any Health Care Laws;
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Regulatory Authorisations has the meaning given in Warranty 13.2;
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Regulatory Authorisations means any authorisations required pursuant to the Regulatory Requirements;
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Related to Regulatory Authorisations

  • Regulatory Authorities means the Commissions and the Exchange;

  • Safety Authorisation and “deemed Safety Authorisation” have the meanings given to “safety authorisation” and “deemed safety authorisation” by the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

  • Authorisations means any consent, registration, filing, notarisation, licence, approval, permit, authority or exemption from, by or with any Governmental Authority and all corporate, creditors’, shareholders’ and third-party approvals or consents;

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory agencies, departments, bureaus, commissions, councils, or other government entities (e.g., the FDA and EMA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of Products.

  • 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.

  • Product Authorizations means any and all approvals, including applicable supplements, amendments, pre- and post-approvals, clearances, licenses, notifications, registrations, certifications or authorizations of any Governmental Authority, any Standard Body necessary for the manufacture, development, distribution, use storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

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

  • statutory authority means Central or State Government, quasi-Government, administrative, judicial, public or statutory body, department, instrumentality, agency, authority, board entrusted with and carrying any statutory functions, as required from time to time in connection with performance by the Preferred Bidder of its obligations hereunder;

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

  • 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;

  • Required Governmental Approvals With respect to each Facility, all licenses, permits, accreditations, authorizations and certifications from any Governmental Authority which are material to or required for (i) the operation of such Facility and any Capital Addition thereto for its Primary Intended Use in accordance with all applicable, material Legal Requirements, including, without limitation, material state facility licenses, certificates of need, permits, provider agreements and accreditations or certifications from Medicare and/or Medicaid, and (ii) for any other use conducted on the Leased Property of such Facility and any Capital Additions thereto as may be permitted from time to time hereunder in accordance with all applicable, material Legal Requirements.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • 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 Agencies The Office of the Comptroller of the Currency; the Board of Governors of the Federal Reserve System; the Federal Deposit Insurance Corporation; the Federal Housing Finance Agency; the Securities and Exchange Commission; and the Department of Housing and Urban Development.