Regulatory Authorisation definition

Regulatory Authorisation means any Authorisation required under any law or regulation or by or from any Regulatory Authority necessary or material to the conduct of the business of the Company and its Subsidiaries as it is being conducted from time to time and to comply with its obligations under the Finance Documents.
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Regulatory Authorisation means any consent, authorisation, licence, permit, approval or waiver from any Regulatory Authority that is necessary for the carrying on of the business of each MGA Group Company in the manner that it is contemplated by the Binder Agreements;
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Regulatory Authorisation means any authorisation issued by, or applied for to, the Relevant Regulatory Authorities of any relevant country or group of countries to manufacture, import, distribute (commercially or for clinical or other research purposes), develop, conduct studies or trials or, market and/or sell the Products (as applicable) in such country or group of countries.
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Examples of Regulatory Authorisation in a sentence

  • The guidance to be provided by the Company may include, among other things, assistance with the preparation, drafting or submission of any application for Regulatory Authorisation (such as a clinical trial application) or communication with any Regulatory Authority in connection with the Clinical Trial.

  • The Process of Regulatory Authorisation [1]Comment: Probably this sentence can be omitted if the proposed change on theprevious sentence is accepted....

  • COVID-19 Vaccines: The Factors that Enabled Unprecedented Timelines for Clinical Development and Regulatory Authorisation.

  • The point at which any member of Ascenders becomes aware of all of the Minimum Information relating to a report of an Adverse Event (as defined in 2.4) Regulatory Authorisation Authorisations granted by the relevant regulatory authorities, necessary to market the Medicinal Product in a given country/region.

  • No budget adjustments are necessary as this award was anticipated and accounted for during the budget process for fiscal year 2019.

  • The Process of Regulatory Authorisation: a Report by the CRPPH Expert Group on the Regulatory Application of Authorisation.


More Definitions of Regulatory Authorisation

Regulatory Authorisation means any consent, authorisation, licence, permit, approval or waiver from any Regulatory Authority that is necessary for the carrying on of the business of each Group Company in the manner that it is carried on at the date of this Agreement; “Regulatory Authority” means the PRA, the FCA, the BMA, Lloyd’s and such other governmental or regulatory authorities that have responsibility for regulating the Group; “Regulatory Conditions” means each of the conditions listed in paragraphs 1 and 2 of Schedule 5; “Related Person” means: (i) a person that, directly or indirectly, is Controlled by one or more Existing Shareholders (and for these purposes “Control” shall mean the possession, directly or indirectly, of the power to direct the management and policies 10
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Related to Regulatory Authorisation

  • 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;

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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.

  • Authorisations means authorisations, orders, grants, recognitions, determinations, certificates, confirmations, consents, licences, clearances, provisions and approvals, in each case, of a Third Party.

  • 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;

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

  • FDA means the United States Food and Drug Administration.

  • Authorisation means an authorisation, consent, approval, resolution, licence, exemption, filing, notarisation or registration.

  • Regulatory Agency means any federal or state agency charged with the supervision or regulation of depositary institutions or holding companies of depositary institutions, or engaged in the insurance of depositary 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 or any of its subsidiaries.

  • Cemetery authority means any person who owns or operates a cemetery specified in s. 157.065 (1).

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • 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.