Regulatory work definition

Regulatory work which means
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Regulatory work shall have the meaning set forth in Section 4.1.
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Regulatory work means any work related to obtaining or maintaining Regulatory Approval, including post Regulatory Approval work, in any country of the Territory for the sale of a Product.
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Examples of Regulatory work in a sentence

  • Regulatory work on standards, quality, borders and trade facilitation, as well as investments in economic corridors are being supported by the ADB, Eurasian Economic Commission, China, and Kazakhstan.

  • Regulatory work is progressing towards establishing the Myanmar Communications Regulatory Commission, and corporatization of the Myanmar Post and Telecommunications (MPT).

  • Personnel undertaking CFP Regulatory work must be authorised to do so.

  • Before joining the firm, he worked with PriceWaterhousecoopers (Pwc) and Ernst & Young (E&Y) for about five years, where he handled Tax and Regulatory work for various international and offshore clients.In B&B, his primary responsibilities with respect to clients have been assessing inherent business risks and performing risk assessments at the audit entity and process levels.

  • Regulatory work, would include approving permits, and the technician’s work would be subject to the supervision and approval of his or her supervising CEHP.69 68 Section 20.03(8), F.S., defines “department” as the principal administrative unit within the executive branch of state government.69 Department of Health, 2024 Agency Legislative Bill Analysis, SB 1582 (Sept.

  • Regulatory work and legislation to decrease or eliminate exposure of potent contact allergens are important, since environmental exposure is of major importance for the development of sensitization.

  • Regulatory work in the area of S&T remains in the responsibility of thematic ministries.An important coordinative role in the area of S&T and innovation policy-making belongs to the Ministry of Education and Science of the RF (Minobrnauki or MES Russia).

  • Regulatory work, paper copies of data, electronic copies of data.

  • Regulatory work requires skills sufficient to identify, interpret, and evaluate complex regulatory factors and related natural, cultural and social conditions and to prepare or evaluate the adequacy of environmental documentation or similar analyses, such as those conducted under the National Environmental Policy Act, Section 404(b)(1) Guidelines, Endangered Species Act, and National Historic Preservation Act.

  • Regulatory work involves a wide variety of responsibilities related to the enactment, implementation, and enforcement of regulations.

Related to Regulatory work

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • 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.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • 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;

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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 entity means any board, commission, agency,

  • Project Work means the work required to complete the Project.

  • 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;

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • 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 any pricing or reimbursement approvals, as applicable, 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.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Regulatory Information Service means a regulatory information service as defined in the Takeover Rules.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Regulatory Problem means any set of facts or circumstance wherein it has been asserted by any governmental regulatory agency (or a Regulated Stockholder reasonably believes that there is a risk of such assertion) that such Regulated Stockholder is not entitled to acquire, own, hold or control, or exercise any significant right (including the right to vote) with respect to, any Equity Securities of the Company or any subsidiary of the Company.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.