Regulatory Authorisation definition

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;
Sample 1Sample 2
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.
Sample 1
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
Sample 1

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.

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

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

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

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


More Definitions of Regulatory Authorisation

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.
Sample 1

Related to Regulatory Authorisation

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • 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 Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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.

  • 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;

  • 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.

  • 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;

  • 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;

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

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

  • 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;

  • 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.

  • 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).

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

  • Necessary Authorizations means all approvals and licenses from, and all filings and registrations with, any governmental or other regulatory authority, including, without limiting the foregoing, the Licenses and all approvals, licenses, filings and registrations under the Communications Act, necessary in order to enable the Borrower and its Subsidiaries to own, construct, maintain, and operate communications tower facilities and to invest in other Persons who own, construct, maintain, manage and operate communications tower facilities.

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

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

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • 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.

  • 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 for Regulatory Approval in a country, territory or possession.

  • 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.

  • Relevant Electric Retail Regulatory Authority means an entity that has jurisdiction over and establishes prices and policies for competition for providers of retail electric service to end- customers, such as the city council for a municipal utility, the governing board of a cooperative utility, the state public utility commission or any other such 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.