Pharmaceutical Application definition

Pharmaceutical Application means applications where devices, kits, or medications incorporating leucoanthocyanidins, anthocyanidins and anthocyanins are used (a) in the diagnosis, cure, mitigation, treatment, or prevention of disease (b) in or as articles (other than food) intended to affect the structure or any function of the body of man or other animals
Pharmaceutical Application means any product that (i) requires and is indicated for the treatment of a specific medical condition by a regulatory agency and (ii) is administered under the supervision of a clinician. For greater clarity, nutritional or dietary supplements, even if they are consumed as a medicinal product, shall not be considered a Pharmaceutical Application, whereas prescription products and the products classified as Medical Foods by US FDA regulations (and equivalent regulations in foreign territories with comparable guidelines) are Pharmaceutical Applications. In the event that the US FDA (and equivalent agencies in foreign territories) changes or alters its regulations and reclassifies the use of nutritional, dietary or any existing Products of Licensee and/or its Affiliates that are derived from APP into the Pharmaceutical Applications category, Licensee shall retain the right to such Products (which will continue to be Products for purposes of the Agreement), provided however that such Products are actively marketed or sold at the time of the reclassification, and that Licensee is required to meet such new regulations in a timely manner.

Examples of Pharmaceutical Application in a sentence

  • He is an author and has two patents pending in Dental Technological Devices and one with a Pharmaceutical Application.

  • For greater clarity, nutritional or dietary supplements, even if they are consumed as a medicinal product, shall not be considered a Pharmaceutical Application, whereas prescription products and the products classified as Medical Foods by US FDA regulations (and equivalent regulations in foreign territories with comparable guidelines) are Pharmaceutical Applications.

  • Partition, Adsorption, Ion exchange, Size exclusion and Thin layer, HPTLC and its Pharmaceutical Application.

  • The FDA’s PAT team worked with ASTM International to establish the Technical Committee E55 on Pharmaceutical Application of Process Analytical Technology.

  • Chinyere, Physicochemical and morphological properties of Irish and Corn starch modified with Gum Arabic for improved food and Pharmaceutical Application (Masters theses, University of Jos), 2015.

  • Principle of the Pharmaceutical Application of Antimicrobial Agents.

  • Subject to the terms of this Agreement, Foundation grants to Licensee a non-exclusive license under the Patent Rights and Know-How and Material Rights to make, have made, use, sell and offer for sale Licensed Products and Licensed Services in the Field for Pharmaceutical Application and Territory and during the Term.

  • If the parties fail to reach an agreement with respect to any such Pharmaceutical Applications, CLINTEC may solicit other offers and engage in negotiations with third parties with respect to that specific Pharmaceutical Application.

Related to Pharmaceutical Application

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

  • Practical application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or government regulations, available to the public on reasonable terms.

  • Pharmaceutical care means the provision of drug therapy and

  • 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.

  • 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.

  • 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”).

  • 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;

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • 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.

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

  • 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.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • 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.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

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

  • 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.

  • Commercial applicator means a person who, by contract or for hire, engages in the

  • 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.

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

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • 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.”

  • Therapeutic school means a residential group living facility: