pharmaceutical dossier means a set of documents as specified in Schedule-I;
Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).
Pharmaceutical means any compound or mixture, other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease in human and animal.
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.
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.
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”).
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.
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.
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;
Therapeutic school means a residential group living facility:
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.
MFDA means the Mutual Fund Dealers Association of Canada;
Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.
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:
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.
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 paraphernalia means all equipment, products, and materials of any kind, which are used for injecting, ingesting, inhaling or otherwise introducing a drug into the human body. This includes, but is not limited to, all equipment, products and materials prohibited or controlled by State or Federal laws.
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.
Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.
Drug means (i) articles or substances recognized in the official United States Pharmacopoeia
FDA means the United States Food and Drug Administration.
Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.
Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products
Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):
Product means any deliverable under the Contract, which may include commodities, services, technology or software.
ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.