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.

  • Pharmaceutical Application of rDNA technology- Production of recombinant proteins, insulin, growth hormones, interferon, monoclonal antibodies.

  • Katherine Sanderson, 3D Printing and Its Pharmaceutical Application, INT’L FED’N PHARMACEUTICAL WHOLESALERS, June 2015, at 1.

  • Slurry Hydrogenation in a Continuous Flow Reactor for Pharmaceutical Application.

  • Principle of the Pharmaceutical Application of Antimicrobial Agents.

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

  • How will you prepare and standardize 0.1 N perchloric acid.3. Attempt any three : (5×3=15)Write short note on :1) Specific and molecular rotation and optical activity.2) Buffer solution3) Various type of conductometric titration.4) Pharmaceutical Application of redox titration.

  • We also propose that where self-funding has occurred, any resulting information on the effectiveness of the treatment would not be considered in any PHARMAC decision on a Named Patient Pharmaceutical Application.

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

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

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

  • 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.

  • 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.

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

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

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

  • Distillery manufacturing license means a license issued in accordance with

  • 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 any person, unless exempted in I(4) hereunder, whether or not the person is a private applicator with respect to some uses, who:

  • 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 to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.