Pharmaceutical Regulatory Authority definition

Pharmaceutical Regulatory Authority means, with respect to any regulatory jurisdiction, any national, federal, supranational, regional, state, provincial or local governmental or regulatory authority, agency, department, bureau, commission, council or other Governmental Entity, including the FDA and EMA, regulating or otherwise exercising authority with respect to pharmaceutical products in such regulatory jurisdiction;
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Examples of Pharmaceutical Regulatory Authority in a sentence

  • Continuation and re-naming of Pharmaceutical Regulatory Authority 4.

  • For example, Biocon production facility in Malaysia was commissioned in 2010 and was certified by Malaysia’s National Pharmaceutical Regulatory Authority (NPRA) in 2015.

  • Except as otherwise contemplated by this Section 7.8 or Section 9.3(b), Acorda will have the sole responsibility and authority for filing all documents with all Pharmaceutical Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Pharmaceutical Regulatory Authority approval for the incorporation into Marketed Product to be marketed, distributed and sold in the Territory of Supplied Product to be Manufactured hereunder.

  • PEPFAR/DRC, through USAID has been appointed recently as lead of the health donors supply chain group and as such, co-lead the National Medicines Commission with the National Pharmaceutical Regulatory Authority.

  • Notwithstanding the other provisions of this Section 7.8, Manufacturer will be responsible for obtaining and maintaining, at all times during the Term, all approvals, permits, licenses, registrations, DUNS number, authorizations, or qualifications required from any Authority (including any Pharmaceutical Regulatory Authority) required in order for it to operate in all respects the Manufacturing Site in order to conduct the Manufacturing Services as contemplated herein.

  • Key Regulatory AgenciesThe key regulatory agencies which play a role in digital healthcare and digital medicine include the Ministry of Health, the Medical Device Authority, the Medicine Advertisements Board of Malay- sia and the National Pharmaceutical Regulatory Authority of Malaysia.

  • Submission, payment of fees and processing of applications Submission of application All application accompanied by prescribed fees shall be addressed and submitted in person or by courier to: The Director General, Pharmaceutical Regulatory Authority, Plot No. 6903, Tuleteka Road, Rhodespark, P.O Box 31890, Lusaka, Zambia When an application has been received, an acknowledgement will be issued together with reference number for each product.

  • The facility is Asia’s largest integrated insulins manufacturing facility with approvals from several global agencies including National Pharmaceutical Regulatory Authority (‘NPRA’), Malaysia, cGMP certification from HPRA (‘EMA’) and cGMP certification from the U.S. Food and Drug Administration (‘USFDA’).

  • Overall, the import market was perceived as difficult to enter, mainly due to the high transaction costs involved, including the fees charged by the Pharmaceutical Regulatory Authority to register products.

  • Key areas of DSBLwork are, coordinating activities related to procurement and supply chain operations and their management for essential medicines and medical supplies, working closely with various programs and government institutions such as Medical Stores Limited and the Pharmaceutical Regulatory Authority.

Related to Pharmaceutical Regulatory Authority

  • 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.

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

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

  • 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.

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

  • Regulatory Authorities means the Commissions and the Exchange;

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • 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;

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • 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;

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Pharmaceutical care means the provision of drug therapy and

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • 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.

  • 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.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Drug means (i) articles or substances recognized in the official United States Pharmacopoeia