Finished Pharmaceutical Product definition

Finished Pharmaceutical Product means a medicine presented in its finished dosage form that has undergone all stages of production, including packaging in its final container and labeling. Good Manufacturing Practices (GMP) means the practices, which ensure that Finished Pharmaceutical Products are consistently produced and controlled according to quality standards appropriate to their intended use, and as required by applicable marketing authorizations. Health Products includes (i) Finished Pharmaceutical Products;(ii) durable health products (including but not limited to bednets, laboratory equipment, radiology equipment and supportive products); and (iii) consumable/single-use health products (including but not limited to condoms, rapid and non-rapid diagnostic tests, insecticides, aerial sprays against mosquitoes, breast milk substitute and injection syringes). International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) is an initiative involving regulatory bodies and pharmaceutical industry experts that was established to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration. ICH member countries are specified on its website: xxxx://xxx.xxx.xxx .
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Finished Pharmaceutical Product means any chemical substance or product meant for the consumption of the end user;
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Finished Pharmaceutical Product means a product that has undergone all the stages of production, including packaging in its final container and labelling;
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Examples of Finished Pharmaceutical Product in a sentence

  • This includes, but is not limited to, the following: • Finished Pharmaceutical Product (FPP) formulation; • Method and site of manufacture; • Source and specifications of active and excipient starting ingredients; • FPP specifications; • Materials and specifications of the packing (primary, secondary, pack size, label and package insert); • Shelf life and storage condition; • Product information.

  • This includes, but is not limited to, the following:  Finished Pharmaceutical Product (FPP) formulation;  Method and site of manufacture;  Source and specifications of active and excipient starting ingredients;  FPP specifications;  Materials and specifications of the packing (primary, secondary, pack size, label and package insert);  Shelf life and storage condition;  Product information.

  • This includes, but is not limited to, the following:  Finished Pharmaceutical Product (FPP) formulation;  Method and site of manufacture;  Source and specifications of active and excipient starting ingredients;  FPP specifications;  Materials and specifications of the packaging (primary, secondary, pack size, label and package insert);  Shelf life and storage condition;  Product information.

  • A Finished Pharmaceutical Product will be eligible for review by the Expert Review Panel if it has not yet been prequalified by the WHO Prequalification Programme or authorized for use by a Stringent Drug Regulatory Authority, but meets the following criteria: i.


More Definitions of Finished Pharmaceutical Product

Finished Pharmaceutical Product means a formulated and finished pharamaceutical product containing Lenacapacvir as the sole active ingredient as: (a) an injectable drug product containing 309 mg/mL Lenacapavir injection in a vial that is copackaged with device components required for dose administration in a vial kit configuration or (b) an oral tablet drug product containing 300mg of Lenacapavir.
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Finished Pharmaceutical Product means any chemical sub- stance or product meant for the comsumption of the end user;
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Related to Finished Pharmaceutical Product

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

  • 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.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical or biological ingredient as further set forth in the applicable Product Manufacturing Plan.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • 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;

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate):

  • 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.

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

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • API means American Petroleum Institute.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Interchangeable biological product means a biological product that the federal Food and Drug Administration has:

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

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

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Products means information resources technologies that are, or are related to, EIR.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • processed products means goods placed under a processing procedure which have undergone processing operations;