Healthcare Regulatory Authority definition

Healthcare Regulatory Authority means any federal, national, foreign or multinational governmental health regulatory agency or authority with jurisdiction over (a) the development, marketing, labeling, sale, use, handling and control, safety, efficacy, reliability, manufacturing, approval, or licensing of any drug, device or over-the-counter pharmaceutical product, (b) healthcare programs under which such products are purchased, or (c) the protection of personal health information, including Notified Bodies established by European Union member states to assess whether products comply with the EU Medical Devices Directive.

Healthcare Regulatory Authority means any federal, national, foreign or multinational governmental health regulatory agency or authority with jurisdiction over (i) the research, development, marketing, labeling, sale, distribution, use, handling and control, safety, efficacy, reliability, manufacturing, approval, licensing of any drug or medical device, (ii) federal healthcare programs under which such products are purchased or (iii) the protection of personal health information. References in this Agreement to Healthcare Regulatory Authority shall be deemed to include the EMA and the FDA, the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, the U.S. Department of Health and Human Services, Office of Civil Rights, and the Federal Trade Commission and their equivalent foreign entities.

Healthcare Regulatory Authority means any federal, national, foreign or multinational governmental health regulatory agency or authority with jurisdiction over (i) the development, marketing, labeling, sale, use, handling and control, safety, efficacy, reliability, manufacturing, approval, licensing of any drug, device or over-the-counter pharmaceutical product, (ii) federal healthcare programs under which such products are purchased or (iii) the protection of personal health information. For clarity, references in this Agreement to Healthcare Regulatory Authority shall be deemed to include the EMA and the FDA, the Centers for Medicare and Medicaid Services, the United States Department of Justice, the United States Department of Health and Human Services, Office of Civil Rights, and the Federal Trade Commission and their equivalent foreign entities.

Examples of Healthcare Regulatory Authority in a sentence

• As used herein, “Healthcare Regulatory Authorizations” means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Healthcare Regulatory Authority, including all investigational new drug applications and new drug applications.

• As of the date of this Agreement, the Company has not received any written notification of any pending or, to the knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority.

• This Section 4.07 does not relate to compliance with Laws or Governmental Authorizations to the extent relating to Tax matters, which are the subject of Section 4.08, Intellectual Property matters, which are the subject of Section 4.09, or compliance with (i) the rules or regulations of the FDA or any comparable Healthcare Regulatory Authority having jurisdiction over the Asset Seller Entities or (ii) matters the subject of Food and Drug Laws and Health Care Laws, which are the subject of Section 4.12.

• MHRA (Medicine and Healthcare Regulatory Authority) – in accordance with the EU Directive, the MHRA is the Competent Authority of the UK.

• The document has been compiled principally to meet with requirements of the United Kingdom Accreditation Service (UKAS), The Blood Safety & Quality Regulations (as formally inspected by the Medicines & Healthcare Regulatory Authority (MHRA)), and Good Manufacturing (Laboratory) Practice (GMP), and, other relevant National and International Quality Standards.

More Definitions of Healthcare Regulatory Authority

Healthcare Regulatory Authority. The FDA, the DEA or any other Governmental Authority that is concerned with or regulates the development, approval, labelling, marketing, sale, use, handling and control, safety, efficacy, reliability or manufacturing of drug or biological products or is concerned with or regulates public health care programs.

Healthcare Regulatory Authority means the FDA and any other applicable Governmental Entity responsible for the oversight and approval of the research, development or commercialization of pharmaceutical or medicinal products of Greenbrook, Neuronetics and each of their respective Subsidiaries, as applicable;

Healthcare Regulatory Authority means any Governmental Authority that regulates or has jurisdiction over any Health Care Law.

Healthcare Regulatory Authority is defined in Section 2.13(a) of the Agreement.

Healthcare Regulatory Authority means any Governmental Authority that regulates or has jurisdiction over any federal, state, local, municipal or foreign Health Care Law, including but not limited to the U.S. Food and Drug Administration (“FDA”) and the U.S. Centers for Medicare & Medicaid Services, the U.S. Department of Health and Human Services, Office of Inspector General, the U.S. Federal Trade Commission, the U.S. Department of Justice with respect to enforcement of Health Care Laws, the European Medicines Agency, EU Notified Bodies and EU national authorities, Health Canada, the U.K. Medicines and Healthcare Products Regulatory Agency, the Brazilian Health Surveillance Agency and the Australian Therapeutic Goods Agency.

Healthcare Regulatory Authority means any Governmental Entity with jurisdiction over (a) the research, development, marketing, labeling, sale, distribution, use, handling and control, safety, efficacy, reliability, manufacturing, approval, licensing of any drug or medical device, (b) federal healthcare programs, (c) commercial or private insurance entities or companies or (d) the protection of personal or health information. For the avoidance of doubt the FDA, the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, the U.S. Department of Health and Human Services, Office of Civil Rights, State Departments of Insurance, and the Federal Trade Commission and their equivalent state, local and foreign entities as well as notified bodies shall each constitute a Healthcare Regulatory Authority.

Healthcare Regulatory Authority means CMS, FDA, federally recognized but privately operating accrediting organizations, or any other federal, state, local or foreign Governmental Authority, including such entities that are concerned with or regulate public health care programs.