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

  • TEKMIRA shall grant OXFORD, permission to provide the applicable Regulatory Authorities reference access to TEKMIRA’s Investigational Medicinal Product Dossier in a timely manner sufficient to meet OXFORD’s obligations under this Agreement.

  • Such licence is restricted to LICENSEES' sole use of submitting the B Product Dossier and C Product Dossier from TEVA with the relevant Regulatory Authorities in order to obtain in their own name one or more Marketing Authorisations of the respective B Products and/or C Products from TEVA in the Territory as agreed in writing between the Parties.

  • TEVA shall have the right to remove any A Products from such list at any time prior to the date of transfer by TEVA of the A Product Dossier to LICENSEES pursuant to Clause 4.2 below.

  • In case the Timber Product Dossier is deemed compliant with VNTLAS requirements, the Licensing Authority shall issue the FLEGT licence for the shipment.

  • The forest product packing list is a mandatory document in the Timber Product Dossier at each stage of the timber supply chain.

  • The Charity will prepare the Investigational Medicinal Product Dossier (“IMPD”) and the Investigator’s Brochure (“IB”) in respect of the clinical aspects of the Clinical Trial, and submit the IMPD and IB to the relevant Regulatory Authority.

  • 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.

  • In addition, BDB shall report and furnish to INFLARX in English language the up to date version of the lnvestigational Medicinal Product Dossier (“IMPD”) or parts thereof and study synopsis within [*****] upon written request (email sufficient).

  • The content of the Timber Product Dossier for FLEGT licensing, including any specific requirements for samples and demonstration products, shall be specified in the regulation on FLEGT licensing to be issued by the Government of Viet Nam after signing of the Agreement.

  • For the avoidance of doubt, any delay caused in obtaining Regulatory Approval due to actions, inactions or requirements of the Regulatory Authorities in the United States or in the Territory or due to any changes in Applicable Law shall extend the [***] and [***] time periods referenced above until such time that a submission of the Product Dossier or a decision concerning Regulatory Approval of the Licensed Product can be rendered by the Regulatory Authorities.


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 particular pharmaceutical product and a particular country, (a) the full prescribing information for the product approved by the applicable Regulatory Authorities in such country, including any required patient information; and (b) all labels and other written, printed or graphic matter physically upon a container, wrapper or any package insert utilized with or for the product in such country.