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.
Source 1Source 2
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;
Source 1Source 2
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;
Source 1

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).

  • 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.

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

  • 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.

  • 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.In November 2019, the Company entered into a License and Exclusive Supply Agreement with AFT Pharmaceuticals Ltd (“AFT”) to acquire a license to market, sell and distribute a portfolio of pain management products in Canada.The Company launched the Combogesic® product in Canada in December 2020.

  • 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.


More Definitions of Product Dossier

Product Dossier means Customer’s product dossier for the Products.
Source 1

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 in the Territory, (i) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country, including any required patient information and (ii) 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.