Product Dossier definition

Product Dossier means the collection of the various documents and data (including Regulatory Data and Regulatory Documentation) concerning the research, development safety and efficacy of the Licensed Product.
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Product Dossier means such package of technical and clinical information concerning the Product as is necessary for, or useful in connection with, obtaining and maintaining Regulatory Approval for the Product in the Territory and includes, without limitation, the package insert, data in support of registered indications, bioequivalency data and information, clinical data, pharmaco toxicological data, analytical methods, stability and pharmaceutical data concerning the Product in the possession or control of PERNIX.
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Product Dossier means Customer’s product dossier for the Products.
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Examples of Product Dossier in a sentence

  • Therefore, the proposed actions should focus on late preclinical (e.g. validation in animal models, toxicology, Good Manufacturing Practices (GMP) production, preparation of Investigational Medicinal Product Dossier) and early clinical (up to phase 1) development of already existing lead drug and vaccine candidates.

  • Please refer to the SmPC and Investigational Medicinal Product Dossier (IMPD) for more details about the active and placebo IMPs. Ratiopharm Spironolactone does not have any special storage conditions (Please see Appendix 1: 6.4 Special Precautions For Storage).

  • WHO Guidance on Variations To A Prequalified Product Dossier, 20075.

  • A separate Investigational Medicinal Product Dossier (IMPD) will provide the detail of this process.

  • There are specific considerations in case of substantial modifications to the Investigational Medicinal Product Dossier (IMPD).

  • Further information on REALIST ORBCEL-C and Plasma-Lyte 148 (placebo control) can be obtained from the Investigational Medicinal Product Dossier (IMPD).

  • Please refer to the Summary of Product Characteristics and Investigational Medicinal Product Dossier (IMPD) for more details about the active and placebo IMPs.

  • Concawe Product Dossier Nn. 01/54.· * Data compared to the previous version altered.

  • In case the Timber Product Dossier is not compliant with VNTLAS requirements, the Licensing Authority shall reject the FLEGT licence application for the shipment and shall take action in line with applicable legislation in case of any detected violations.

  • In case of (a) any violation or fraudulent information related to the Timber Product Dossier for FLEGT licensing, or (b) counterfeiting, altering or modifying information in the licence, or infringement of the licensing regulations, administrative or legal measures shall apply according to the level of violation, in line with Vietnamese law and regulations.

Related to Product Dossier

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • 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;

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

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority‑approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • Licensed Product means any product or part thereof which:

  • Collaboration Product means any product that contains one or more Discovered RNAi Compound(s) as active ingredient(s).

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Product Documentation means the specific materials listed under “Product Documentation” at xxx.xxxxxx.xxx/xxxxx, as updated by Vocera from time to time.

  • DMF means a Drug Master File for Captisol, as filed as of the Effective Date, or as hereafter updated from time to time during the Term, by CyDex with the FDA.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • 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.

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

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • 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.”

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

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

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

  • Territory means worldwide.

  • Licensed Territory means worldwide.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Drug means (1) a controlled substance recognized as a drug in the official United States pharmacopoeia/national formulary or the official homeopathic pharmacopoeia of the United States, or any supplement to them; (2) controlled substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in individuals or animals; (3) controlled substances (other than food) intended to affect the structure or any function of the body of individuals or animals; and (4) controlled substances intended for use as a component of any article specified in (1), (2), or (3) of this subsection. The term does not include devices or their components, parts, or accessories.

  • 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.

  • BLA means basic liquidity adjustment which is 0% or 25% as determined by Fitch in accordance with the Fitch Criteria;

  • customs territory means the territory of the country of each Contracting Party in which the Customs laws of that country are in force;