Regulatory issues definition

Regulatory issues means issues relating to the application of any EU instrument relating to EU marketing authorisations or to medical devices, or any enactment which implements such an instrument;
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Regulatory issues. A Manager is required to categorize all new customers in one of three customer categories; eligible counterparties, professional and non-professional clients. All investors that are applying for Offer Shares in the Private Placement and which are not existing clients of a Manager will be categorized as non-professional clients unless otherwise is communicated in writing by the relevant Manager. For further information about the categorization the Applicant may contact the Manager. The Manager will treat the Application as an execution only instruction from the Applicant to apply for Offer Shares under the offer and hence the Manager will not determine whether the Application for Offer Shares is suitable or not for the Applicant6.
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Regulatory issues include, but are not limited to any of the following: (i) Employee has ever been convicted of, or pled guilty or nolo contendere to, a criminal offense of any kind other than civil or misdemeanor traffic offenses, (ii) Employee has ever been arrested, indicted or charged with a criminal offense under any federal or state law of any kind, other than a civil or misdemeanor traffic offense, (iii) Employee has ever been charged with or convicted of violation of any controlled substance laws or any federal or state cannabis laws, (iv) Employee has been named as a defendant in a civil or administrative lawsuit where the allegations would constitute a crime or would amount to fraud, deceit or misrepresentation, excepting any suit that concluded with a merit finding in Employee’s favor, (v) Employee owes any past taxes, fees or obligations to the United State government, any state or any political subdivision thereof, (vi) Employee has failed to comply with any applicable laws or regulations relating to child support, (vii) Employee has been named as a defendant in any administrative EEOC matter or named in a lawsuit alleging discrimination, harassment or hostile work environment, excepting any such matters that concluded with a merit finding in Employee’s favor, (viii) a court, governmental agency or tribunal has determined that the Employee has engaged in attempt to obtain a registration, license or approval to operate in any state by fraud, misrepresentation or the submission of false information or (ix) Employee has ever been subject to any denial, suspension or revocation of a license or registration by any federal, state or local government, or any foreign jurisdiction, including without limitation, any denial, suspension, revocation or refusal to renew certification for Medicare or Medicaid.
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Examples of Regulatory issues in a sentence

  • The section also shows to whom these powers have been delegated (if at all) – whether to a Committee or to an officer.3.3 Section 2 sets out those powers and duties which the Act excludes from Cabinet decision making – such as Planning, Licensing and Licensing Regulatory issues.

  • The Company participates in putting forward its views on various Regulatory issues at the appropriate forums.Principle 8: Businesses should support inclusive growth and equitable development (P8)1.

  • Regulatory issues and updates are communicated to staff through memoranda, meetings and education sessions.

  • Regulatory issues and updates are communicated to staff through memoranda, meetings and educations sessions.

  • After the 2005 hurricanes NRCS, utilizing their Emergency Watershed Protection authority, also worked closely with USACE regarding Regulatory issues relating to the restoration of scenic stream channels.

  • The literature supporting 68Ga Dotatate in neuroendocrine tumours is large and robust.∆ The European Neuroendocrine Tumour Society (ENETS) Consensus Guidelines, [8] UK and Ireland Neuroendocrine Tumour Society (UKINETS) Guidelines [9] and the Clinical Oncology Society of Australia (COSA) NETS guidelines [6] each endorse the use of 68Ga Dotatate PET/CT in patients with NETs.∆ Regulatory issues present one of the main obstacles to more widespread adoption of 68Ga Dotatate as a diagnostic agent in Australia.

  • Regulatory issues are usually found to have roles in the development of such financial difficulties.

  • Regulatory issues are important limiting factors facing the deployment of UAV-based communication systems.

  • The City of Durham recognizes that there are legal/ Regulatory issues associated with the comprehensive Carbon Neutrality and Renewable Energy Action Plan.

  • That is, the host market can always be expected to have the primary interest in regulatory issues germane to the orderly and fair operation of its securities markets.97 Regulatory issues related to manipulation of stock prices, a host of market micro- structure issues related to trading in securities, and the financial, professional and ethical qualifications of market participants are just a few of the regulatory issues that are inherently within the prerogatives of the regulators of the host market.


More Definitions of Regulatory issues

Regulatory issues. The ongoing operations of the separate companies means that the DLC must satisfy the accounting and regulatory frameworks of two countries. This is likely to be costly, and possibly constrain the ability of management to maximise the joint value of the two companies.
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Regulatory issues means the adoption, implementation, or enforcement of regulations, including but not limited to advocating for or against the adoption, implementation, or enforcement of regulations.
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Regulatory issues. In accordance with MiFID II Regulation of 4 December 2017 no. 1913 and the Norwegian Regulation on supplementary rules to the Norwegian MiFID II and MiFIR Regulations of 20 December 2017 no. 2300 corresponding to Directive 2014/65/EU (the Markets in Financial Instruments Directive) (together referred to as the "MiFID II Regulations"), a Manager must categorize all new customers in one of three customer categories. All investors that are applying for Offer Shares in the Private Placement and which are not existing clients of a Manager will be categorized as Non-professional clients unless otherwise is communicated in writing by the relevant Manager. For further information about the categorization the Applicant may contact the Manager. The Manager will treat the Application as an execution only instruction from the Applicant to apply for Offer Shares under the offer and hence the Manager will not determine whether the Application for Offer Shares is suitable or not for the Applicant as otherwise provided for in the Norwegian MiFID II Regulations. M anagers’ consideration: Each of the Managers will receive a consideration from the Company and will in conducting their work have to take into consideration the requirements of the Company and the interests of the investors subscribing under the Private Placement and the rules regarding inducements pursuant to the requirements of the Norwegian MiFID II Regulations (implementing the European Directive for Markets in Financial Instruments (MiFID II).
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Related to Regulatory issues

  • Regulatory Bodies 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, investigate, or influence the matters dealt with in the Contract or any other affairs of the Authority and “Regulatory Body” shall be construed accordingly.

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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 Authority means any federal, national, multinational, state, county, city, provincial, or local regulatory agency, department, bureau or other governmental entity with authority over the marketing, commercialization, manufacture or sale of a pharmaceutical product in the Territory, including the FDA in the United States and the EMA in the EU.

  • 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 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.

  • 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.

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

  • 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 Order means an order issued by a permitting authority that requires compliance with:

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

  • 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.

  • 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.

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

  • Regulatory entity means any board, commission, agency,

  • Regulator means, with respect to any person, any Government Authority charged with regulating, supervising or examining such person and its Affiliates.

  • Regulatory Costs means, collectively, all future, supplemental, emergency or other changes in Reserve Percentages, assessment rates imposed by the FDIC, or similar requirements or costs imposed by any domestic or foreign governmental authority and related in any manner to the LIBO Rate, provided said amounts are actually paid by (or on behalf of) Lender.

  • 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.

  • 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.

  • 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.

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • Explanatory Indicator means a measure that is connected to and helps to explain performance in a Performance Indicator or a Monitoring Indicator. An Explanatory Indicator may or may not be a measure of the HSP’s performance. No Performance Target is set for an Explanatory Indicator;

  • 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 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.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Regulators means the SFC, the relevant Exchange, the relevant clearing house and any other regulators whether in Hong Kong or elsewhere