Generic Medicine(s) definition

Generic Medicine(s) means generic medicinal product(s) as defined in Article 10(2)(b) of EC Directive 2001/83/EC in respect of which a Marketing Authorisation has been issued by the HPRA or the European Commission

Examples of Generic Medicine(s) in a sentence

  • BPPI after considering the aforesaid request of the “ APPLICANT” and has agreed to allow for establishing and operate Pradhan Mantri Bhartiya Janaushadhi Kendra atin the district of within the state of for sale of Generic Medicines.

  • He was Chairman of the Generic Medicines Industry Association (GMiA) for 5 years.

  • The Australian Generic Medicines Industry Association has found that delays in the entry of generic competition for 39 PBS listed medicines due to secondary patenting cost taxpayers$37.8 - $48.4 million over a 12 month period (Nov 2011-Nov 2012)34 35.

  • See, for example, Generic Medicines Industry Association (2013) Public Response to the Pharmaceutical Patents Review, p.

  • Two of the six members on the committee were ‘industry lobbyists from Medicines Australia and the Generic Medicines Industry Association’ and its recommendations remained private.20 At face value, having significant industry representation in a process that is closed, and has no budgetary constraints on its recommendations for the expenditure of taxpayer funds, appears to have been a recipe for waste and overcharging.

  • BPPI after considering the aforesaid request of the “ APPLICANT” and has agreed to allow for establishing and operate Pradhan Mantri Bhartiya Janaushadhi Kendraatin the district of within the state of for sale of Generic Medicines.

  • All costs, no benefits: how the US-Jordan free trade agreement affects access to medicines, Journal of Generic Medicines (2009) 6(3):206-217, Available from: http://jgm.sagepub.com/content/6/3/206.short.

  • Public Protector of the Republic of South Africa, Report on the Propriety of the Conduct of Members of the Ministry and Department of Health Relating to Statements in Connection with the Prices of Medicines and Utilisation of Generic Medicines in South Africa, Special Report No. 6 (1997).

  • Prior to joining IFPMA, Greg wad Executive Director of the Medicines Patent Pool, which he joined in 2013 and previously as Director General of the European Generic Medicines Association (1999 - 2013) in Brussels.

  • See submissions to the 2012-13 Pharmaceutical Patent Review, particularly those from Alphapharm and the Generic Medicines Industry Association (GMiA).

Related to Generic Medicine(s)

  • 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:

  • Generic String means a string consisting of a word or term that denominates or describes a general class of goods, services, groups, organizations or things, as opposed to distinguishing a specific brand of goods, services, groups, organizations or things from those of others.

  • Therapeutic school means a residential group living facility:

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

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

  • 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.

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Generic Version means, with respect to a Licensed Product, a product (including a “biogeneric,” “follow-on biologic,” “follow-on biological medicine or product,” “follow-on protein product,” “similar biological medicine or product,” or “biosimilar product”) that: (a) within the U.S., is “biosimilar” or “interchangeable,” with respect to such Licensed Product as evaluated by the FDA or otherwise determined by Applicable Law; or (b) in the ROW, is determined by the applicable Regulatory Authority or by Applicable Law to be “similar,” “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” to such Licensed Product. For clarity, a Biosimilar of a Licensed Product shall constitute a Generic Version of such Licensed Product.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Competing Products means any product or service in existence or under development that competes with any product or service of the Company Group about which the Participant obtained Confidential Information or for which the Participant provided advisory services or had sales, origination, marketing, production, distribution, research or development responsibilities in the last twenty-four (24) months of employment with the Company Group.

  • 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.

  • Red Hat Products means Software, Services, Subscriptions and other Red Hat branded offerings made available by Red Hat.

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

  • Competing Product means [***].

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

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

  • 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;

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

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

  • 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.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Therapeutic care means services provided by licensed or certified speech pathologists, Occupational Therapists and Physical Therapists.

  • 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.

  • 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.

  • 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.