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 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.

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

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

  • References to literature and data that are relevant and form the basis for the trial." In the Danish Medicines Agency's view the information about investigational medicinal products, including information about the products' quality, previous trials and toxicological studies, which for example is gathered in the Investigator's Brochure or the Investigational Medicinal Product Dossier (IMPD), is to be considered as forming part of the trial protocol.

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

  • 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.

  • 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.

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.

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

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

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

  • 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.”

  • 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):

  • Territory means worldwide.

  • Licensed Territory means worldwide.

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