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.

  • Principle of the Pharmaceutical Application of Antimicrobial Agents.

  • 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.

  • Chapter 10 - Turmeric: A Review of Its Chemical Composition, Quality Control, Bioactivity, and Pharmaceutical Application.

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

  • 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.

  • 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.

  • 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.

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

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

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 these 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 a drug intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or animals.

  • Biologics License Application or “BLA” means a Biologics License Application (as more fully described in U.S. 21 C.F.R. Part 601.20 or its successor regulation) and all amendments and supplements thereto submitted to the FDA, or any equivalent filing, including an MAA, in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, or any similar application or submission for Regulatory Approval filed with a Regulatory Authority to obtain marketing approval for a biologic product in a country or in a group of countries.

  • 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”), cobicistat (“COBI”), and bictegravir (“BIC”).

  • 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 BLA, sBLA, NDA, sNDA in the United States or any equivalent thereof in any other country or jurisdiction in the world. As used herein: “BLA” means a Biologics License Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 600 et seq., for FDA approval of a Licensed Product and “sBLA” means a supplemental BLA; and “NDA” means a New Drug Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., for FDA approval of a Licensed Product and “sNDA” means a supplemental NDA.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing any usable marihuana that is intended for human consumption in a manner other than smoke inhalation. Marihuana-infused product shall not be considered a food for purposes of the food law, 2000 PA 92, MCL 289.1101 to 289.8111.

  • Commercial Product as used in this Article, means a product in regular production that is sold in substantial quantities to the general public and/or industry at established catalog or market prices. It also means a product which, in the opinion of the Contractor, differs only insignificantly from the Subcontractor’s commercial product.

  • 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 means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Product, including activities related to marketing, promoting, distributing, and importing such Product, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning.

  • Commercial applicator means a person, corporation, or employee of a person or corporation who enters into a contract or an agreement for the sake of monetary payment and agrees to perform a service by applying a pesticide but does not include a farmer trading work with another, a person employed by a farmer not solely as a pesticide applicator who applies pesticide as an incidental part of the person’s general duties, or a person who applies pesticide as an incidental part of a custom farming operation.

  • 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 product or part thereof which:

  • 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: