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 a set of documents – organized according to the guidelines by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or other applicable formats, – related to a health product submitted for assessment to either a regulatory authority for marketing authorization or to the World Health Organization for prequalification or emergency use listing;
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Product Dossier means a file that contains detailed information on the device description, manufacturing, quality control and biomedical studies that demonstrates quality, safety and performance of the finished medical device;
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Examples of Product Dossier in a sentence

  • 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).

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

  • Despite any award or other provision to the contrary, absence on maternity leave does not break the continuity of service of an employee but should not be taken into account in calculating the period of service for any purpose of any relevant award or agreement.

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

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

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

  • The Legal Manufacturer or Reseller must supply the testing laboratory with a full duplicate set of the Product Dossier already supplied to WHO in accordance with the requirements of specification clause 7.

  • This figure was confirmed in a 2016 USAID conflict vulnerability assessment which found land-related issues to be a potential trigger of violent conflict if not handled with caution.

  • Such costs are included in intangible assets as New Product Dossier and Filing Costs and are being amortized ona straight-line basis over the 8-year estimated useful life of the product.

  • Interim results for the three and six months ended June 30, 2016 are not necessarily indicative of results that may be expected for the year ending December 31, 2016.


More Definitions of Product Dossier

Product Dossier means Customer’s product dossier for the Products.
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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 a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

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

  • Product Documentation means the specific materials listed under “Documentation” at

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • 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.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • 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 (i) articles or substances recognized in the official United States Pharmacopoeia

  • 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 a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.