Certificate of Pharmaceutical Product definition

Certificate of Pharmaceutical Product means a document issued by a Regulatory Authority in the Gilead Territory to certify that a Licensed Product has been granted Regulatory Approval in the country of such issuing Regulatory Authority. Certificates of Pharmaceutical Products shall include both documents referred to commonly as "certificates of pharmaceutical product," and "free sales certificates," and documents similar to either of the foregoing but referred to by other names, provided that such similar documents do not impose a substantially greater burden on the applicant than those commonly referred to as "certificates of pharmaceutical products" and "free sales certificates."
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Certificate of Pharmaceutical Product means a certificate of pharmaceutical product substantially in the form published by the World Health
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Certificate of Pharmaceutical Product means a certificate of pharmaceutical product substantially in the form published by the World Health Organisation in connection with the “WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce”;
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Examples of Certificate of Pharmaceutical Product in a sentence

  • In light of the foregoing, and upon Topotarget’s request, Spectrum agrees to reasonably cooperate with Topotarget in obtaining, and Spectrum will use Commercially Reasonable Efforts to obtain, from the FDA or other Regulatory Authority a Certificate of Pharmaceutical Product (CPP) with respect to Product manufactured by any Third Party manufacturers engaged by Spectrum to produce commercial supplies of API and/or Product.

  • From and after the Closing Date, if a legalized Certificate of Pharmaceutical Product (“CPP”) is required in connection with any Regulatory Approval for Arimidex in any country in the Seller Territory, upon Seller’s reasonable request, Buyer shall use commercially reasonable efforts to assist Sellers, at Sellers’ sole expense, in obtaining such CPP.

  • Once Gilead obtains any Certificate of Pharmaceutical Product for Licensed Products for Licensed Indications for the GSK Territory, Gilead shall forthwith provide them to GSK for provision to the relevant Regulatory Authorities in the GSK Territory.

  • Palatin shall cooperate, and take Commercially Reasonable Efforts to secure the United States Certificate of Pharmaceutical Product holder (the “U.S. CPP Holder”) to cooperate, with Fosun such that the application for Regulatory Approval shall be filed in the U.S. CPP Holder’s name as required by the Regulatory Authority in the Territory.

  • Thereafter, to the extent permitted by law, GSK shall assume all responsibility for communication with such Regulatory Authorities in relation to such Certificate of Pharmaceutical Product and any regulatory filings or rights based thereon in such countries during the Term, and for all compliance with law with respect thereto.

  • In particular, Gilead shall not be required to establish any additional manufacturing capacity in any country in order to support the availability of a Certificate of Pharmaceutical Product, [ * ] GSK shall cooperate in all such efforts at its expense.

Related to Certificate of Pharmaceutical Product

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

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Interchangeable biological product means a biological product that the U.S. Food and Drug Administration has:

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.

  • Pharmaceutical means any compound or mixture, other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease in human and animal.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Pharmaceutical care means the provision of drug therapy and

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Radiopharmaceutical service means, but is not limited to, the procurement, storage, handling preparation, labeling, quality assurance testing, dispensing, delivery, recordkeeping, and disposal of radiopharmaceuticals and other drugs.

  • Commercial Product means any such product as defined in FAR 2.101.

  • Mercury-added product means a product or product component that contains mercury or a mercury compound that was intentionally added;

  • API means American Petroleum Institute.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Drug outlet means a pharmacy, nursing home, shelter home, convalescent home, extended care facility, drug abuse treatment center, penal institution, hospital, family planning clinic, student health center, retail store, wholesaler, manufacturer, mail-order vendor or other establishment with facilities located within or out of this state that is engaged in dispensing, delivery or distribution of drugs within this state.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • 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.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.