International Regulatory Agency definition

International Regulatory Agency means any national, provincial, state or local governmental agency or other organization outside of the United States which performs functions similar to the FDA.
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Examples of International Regulatory Agency in a sentence

  • One year later, Eatwell and Taylor (2000) proposed the creation of a International Regulatory Agency, to serve as financial sector rule-setter and supervisor at a global level.

  • In your reply brief, you may not include new arguments in support of your motion.

  • In the case of a Territory with more than one country, the Approval Date shall be the date when approval has been granted by the FDA or the International Regulatory Agency, as the case may be, in at least one-half of the countries in such Territory, including the largest country in such Territory.

  • Any death, serious injury, potential for occurrence of the same, or change in the frequency or occurrence of field experiences with respect to a Product which is required to be reported by a party to the FDA or any International Regulatory Agency shall be reported to the other party as promptly as possible to enable the other party to comply with applicable regulations in a timely manner.

  • Any death, serious injury, potential for occurrence of the same, or change in the frequency or occurrence of field experiences with respect to an R Stent which is required to be reported by a party to the FDA or any International Regulatory Agency shall be reported to the other party as promptly as possible to enable the other party to comply with applicable regulations in a timely manner.

  • USSC shall institute and fund any recall, field corrective action, or the like in any other circumstances relating to a Product defect or failure which requires such action as determined by the FDA, any International Regulatory Agency, USSC, or as otherwise may be required pursuant to applicable laws, rules or regulations if it relates to a defect or failure of a caused by designs produced by USSC.

  • Except as provided for in Section 5.3, OrbusMT shall institute and fund any recall, corrective action, or the like in circumstances relating to a R Stent defect or failure which requires such action as determined by the FDA, any International Regulatory Agency, OrbusMT, or as otherwise may be required pursuant to applicable laws, rules or regulations.

  • SPNC will provide USSC notice of such proposed changes as far in advance as possible in order for USSC to consider such proposed changes and to seek, if appropriate, approvals by the FDA and any International Regulatory Agency (defined below).

  • As an example, the indiscriminate inflow of external resources into a country, in a short period of time, through the relaxation of rules of the digital economy, by decision of the International Regulatory Agency, may stem from geopolitical interference from other countries.

  • Spectranetics shall institute and fund any recall, corrective action, or the like in circumstances relating to an R Stent defect or failure which requires such action as determined by the FDA, any International Regulatory Agency, OrbusMT, Spectranetics or as otherwise may be required pursuant to applicable laws, rules or regulations if 15 * * * This portion has been omitted pursuant to a request for confidential treatment and filed separately with the Commission.

Related to International Regulatory Agency

  • 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.

  • 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.

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

  • 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.

  • 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.

  • Applicable Insurance Regulatory Authority means, when used with respect to any Insurance Subsidiary, the insurance department or similar administrative authority or agency located in (x) the state or other jurisdiction in which such Insurance Subsidiary is domiciled or (y) to the extent asserting regulatory jurisdiction over such Insurance Subsidiary, the insurance department, authority or agency in each state or other jurisdiction in which such Insurance Subsidiary is licensed, and shall include any Federal insurance regulatory department, authority or agency that may be created in the future and that asserts regulatory jurisdiction over such Insurance Subsidiary.

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

  • Public safety agency means a functional division of a public agency, county, or the state that provides fire fighting, law enforcement, ambulance, medical, or other emergency services.

  • international application means an application filed under this Treaty;

  • International Registry means the international registry established pursuant to the Cape Town Treaty.

  • 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.

  • International air transportation means transportation by air between a place in the United States and a place outside the United States or between two places both of which are outside the United States.

  • Health Agency means the California Department of Health Services, or the local health officer with respect to a small water system.

  • 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;

  • Home health agency means a person certified by medicare whose business is to provide to individuals in their places of residence other than in a hospital, nursing home, or county medical care facility 1 or more of the following services: nursing services, therapeutic services, social work services, homemaker services, home health aide services, or other related services.

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

  • international flight means all flights other than Domestic Flights.

  • International Student means a student holding a student visa for the purpose of obtaining an education in Australia and includes a student on a study abroad or international exchange program;

  • statutory authority This agreement implements Iowa Code § 280.25 and is consistent with 34 C.F.R. 99.38 (2012).

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • international registration means the registration of a mark effected under the Agreement or the Protocol or both, as the case may be;

  • International registration plan means a reciprocal agreement of member jurisdictions that is endorsed by the American association of motor vehicle administrators, and that promotes and encourages the fullest possible use of the highway system by authorizing apportioned registration of fleets of vehicles and recognizing registration of vehicles apportioned in member jurisdictions.

  • Council Regulation means Council Regulation (EC) No. 2100/94 of 27th July 1994 on Community plant variety rights;

  • Insurance Regulator means, with respect to any jurisdiction, the Governmental Authority charged with the supervision of insurance companies in such jurisdiction.

  • Public agency means the state or any local subdivision thereof, or any state or local department, agency, board or commission.