Regulatory Health Authority definition

Regulatory Health Authority means any applicable national (for example, FDA or Japan’s Pharmaceuticals and Medical Devices Agency), supranational (for example, the EMA), regional, state, provincial or local regulatory health authority, department, bureau, commission, council, or other government entity regulating or otherwise exercising authority with respect to the Exploitation of Program Compounds or Program Products in the Territory, including any such entity involved in the granting of Regulatory Approval for pharmaceutical products.
Sample 1Sample 2Sample 3
Regulatory Health Authority means any Governmental Authority in the Territory that is concerned with the safety, efficacy, reliability, manufacture, investigation, sale or marketing of pharmaceuticals, medical products, biologics or biopharmaceuticals, including the FDA.
Sample 1Sample 2
Regulatory Health Authority means the state and/or local enforcement authority having jurisdiction over food establishment (FE) or food service establishment (RS).
Sample 1Sample 2

Examples of Regulatory Health Authority in a sentence

  • For imported products Certificate of Registration with GMP Compliance or its equivalent or Valid Sanitary Phyto-Sanitary Certificate or Health Certificate or ISO 22000 Certificate or FSSC Certificate or HACCP Certificate or Certificate of Free Sale issued by the Regulatory/ Health Authority/ Attested by recognized Association or duly authenticated by the Philippine Consulate from the country of origin.

  • Consult with the Regulatory/ Health Authority and the Food Establish-ment’s legal counsel regarding local, state and/or federal laws regarding employee and consumer privacy and the protections required in safeguarding individual health information.

  • Consult with the Regulatory/ Health Authority, Public Relations rep- resentative and/or Legal Counsel before releasing any media statements regarding the outbreak.

  • Certificate of Analysis (E.g. physical, chemical, microbiological and nutrient analysis of the finished product) or Certificate of Free Sale issued by the Regulatory/ Health Authority/ Attested by recognized Association or duly authenticated by the Philippine Consulate from the country of origin.

  • Without limiting the foregoing, each Party shall, in a timely and responsive manner consistent with the requirements of applicable Regulatory Health Authorities, provide to the other Party, in such form and format as may be mutually agreed, (x) copies of all correspondence to or from any Regulatory Health Authority that relates to the Licensed Products, and (y) all Regulatory Documentation then in such Party’s possession or later received by it, its Affiliates or its or their Sublicensees.

  • Active employees are also offered a dental plan, vision coverage, basic life/AD&D, voluntary life, voluntary dependent life, short term disability and long term disability.Medical, Pharmacy, Wellness, & EAP:United Healthcare (UHC) provides the fully insured medical coverage for SLPS.

  • In addition, NIAID is required to provide study- specific regulatory management activities to ensure (i) compliance with the applicable regulations and (ii) integrity of study/trial data in their role as the sponsor of US Investigational New Drug Application (IND) and Investigational Device Exemption (IDE) applications as well as country-specific Regulatory Health Authority (RHA).

  • As part of the Deficit Reduction Act of 2005, Congress created a Medicaid Integrity Program (MIP)23 and increased CMS resources directed toward combating Medicaid fraud and abuse.

  • Certificate of Free Sale indicating that the product is freely sold and fit for human consumption issued by the Regulatory/ Health Authority/ Attested by recognized Association or duly authenticated by the Philippine Consulate or with affixed Apostille from the country of origin (from Manufacturer or Supplier).8.

  • Health Care Professionals (HCPs) play a vital role in the early detection, assessment and reporting of Adverse Drug Reactions (ADRs) to the Regulatory Health Authority or Pharmaceutical Manufacturer.


More Definitions of Regulatory Health Authority

Regulatory Health Authority means the FDA or any successor agency in the United States, and the equivalent regulatory authorities in other jurisdictions of the Territory, e.g., EMEA.
Sample 1
Regulatory Health Authority or “RHA” shall mean any relevant government health authority (or successor agency thereof) in any country of the Territory whose approval is necessary to market the Product in the relevant country of the Territory.
Sample 1
Regulatory Health Authority means any applicable national (for example the PMDA), supra-national, regional, state, provincial or local regulatory health authority, department, bureau, commission, council, or other government entity regulating or otherwise exercising authority with respect to the Exploitation of Licensed Compounds or Licensed Products in the Territory pursuant to the terms and conditions of the License Agreement, including any such entity involved in the granting of Regulatory Approval for pharmaceutical products.
Sample 1

Related to Regulatory Health Authority

  • Health Authority means the regional health board designated under the Health Authority Act, RSBC 1996, c.180, or the Provincial Health Services Authority, to which the Participant is designated under Section 5.4 of this Contract, unless designated otherwise by the Province;

  • 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.

  • Local Mental Health Authority means a county legislative body.

  • Regulatory Authorities means the Commissions and the Exchange;

  • FDA means the United States Food and Drug Administration.

  • 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.

  • Regulatory Authority means, with respect to any national, supra-national, regional, state or local regulatory jurisdiction, any agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such jurisdiction.

  • 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;

  • 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 the insurance department or similar insurance regulatory or administrative authority or agency of the jurisdiction in which the Company is domiciled.

  • medical authority means the medical authority as referred to in clause (p) of section 2 of the Persons with Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act, 1995 or such other medical authority as may, by notification, be specified by the Central Government for certifying “autism”, “cerebral palsy”, “multiple disabilities”, “person with disability” and “severe disability” referred to in clauses (a), (c), (h), (j) and (o) of section 2 of the National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities Act, 1999;

  • Signing Authority means an officer or agent of the organization with written authorization to commit the legal entity to a binding agreement.

  • Regulatory Laws means the HSR Act, the Xxxxxxx Antitrust Act of 1890, as amended, and the rules and regulations promulgated thereunder, the Xxxxxxx Act of 1914, as amended, and the rules and regulations promulgated thereunder, the Federal Trade Commission Act of 1914, as amended, and the rules and regulations promulgated thereunder, and any other federal, state and foreign statutes, rules, regulations, orders, decrees, administrative and judicial doctrines and other Laws that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening of competition through merger or acquisition.

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

  • Contracting Authority means any contracting authority as defined in Regulation 3 of the Public Contracts Regulations 2006.

  • Regulatory Law means the Xxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the HSR Act, the Federal Trade Commission Act, as amended, and all other federal, state and foreign, if any, statutes, rules, regulations, orders, decrees, administrative and judicial doctrines and other laws that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening of competition through merger or acquisition.

  • competent authorities means the competent authorities of the Member States as identified on the websites listed in Annex II;

  • 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;

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

  • Regulatory entity means any board, commission, agency,

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • 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.

  • Aeronautical authorities means, in the case of the People’s Republic of China, the General Administration of Civil Aviation of China, or any person or agency authorized to perform any function presently exercised by the said Administration; and in the case of the Republic of South Africa, the Minister responsible for civil aviation or any person or agency authorized to perform any particular function provided for in this Agreement.

  • Implementing Authority means the Municipal Manager or his or her nominee, acting in terms of section 100 of the Local Government: Municipal Systems Act No. 32 of 2000.

  • 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).

  • 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;