Technical Dossier definition

Technical Dossier means a technical dossier outlining […***…].
Technical Dossier means a document providing such information as detailed in Schedule VII and to be submitted under Rule 10(1);
Technical Dossier means a document providing such information as detailed in Schedule IV and to be submitted under Rule 11(1).

Examples of Technical Dossier in a sentence

  • The characteristics of the components of this System show the following values, which compliance with their respective tolerances stated in the Manufacture Technical Dossier (MTD).

  • Details of the test plan shall be included in the Manufacturer's Technical Dossier.

  • If the Applicant proposes a calculation method to enable unrestricted use, this shall be declared in the ETA and included in the Manufacturer's Technical Dossier.

  • The characteristics of the components of this product show the following values, which are within the respective requirements and tolerances stated in the Manufacture Technical Dossier (MTD).

  • Any infringement of the provisions of the General Terms and Conditions of Participation or of the Exhibitor Technical Dossier may, without prejudice to any other claims, lead to the closure of the stand of the infringing Exhibitor, including where necessary with the assistance of the forces of law and order.

  • The Exhibitor Technical Dossier determines the time limit granted to the Exhibitor to proceed with the fitting-out of his stand prior to the opening of the Event.

  • A list of the agronomic characteristics assessed and their descriptions are found in the Appendix 3 in the Technical Dossier.

  • In the Manufacture Technical Dossier (MTD) the manufacture gives information on the quantities consumed and the processing, which shall lead to a thickness of the roof waterproofing ≥1.2 mm.Execution..

  • In ASEAN, harmonisation of mandatory technical regulations is progressing at a different speed in four sectors (electrical and electronic goods, and cosmetics, for which agreements have been reached; pharmaceuticals, for which Common Technical Requirements and a Common Technical Dossier have been completed44; and for prepared foodstuffs, for 44.

  • However, a MOD Technical Dossier (TD)8 which is specific to each substance and use should be maintained and contain reference to technical and supporting information and authorised at an appropriate management level 9.


More Definitions of Technical Dossier

Technical Dossier means a manual with all documentation mentioned in section 13;

Related to Technical Dossier

  • Technical Documentation means designs, reports, photographs, drawings, plans, specifications, computer software, surveys, calculations and other data, information and material collected, computed, drawn or produced, including computer print-outs.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.

  • Patent Cooperation Treaty means the Patent Cooperation Treaty done at Washington on June 19, 1970;

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • 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.

  • Technical Direction means developing work statements, determining parameters, directing other Contractors' operations, or resolving technical controversies.

  • 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;

  • Technical data means recorded information, regardless of the form or method of the recording, of a scientific or technical nature (including computer software documentation). The term does not include computer software or data incidental to contract administration, such as financial and/or management information.

  • Client Application means an application developed by Customer that a) utilizes the Runtime Product, b) is installed fully on an end user’s machine, with all report processing local to that machine, and c) adds significant and primary functionality to the Runtime Product.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Manufacturing Process means any process for—

  • Commercial applicator means any person, unless exempted in I(4) hereunder, whether or not the person is a private applicator with respect to some uses, who:

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • Certified pharmacy technician or “certified technician” means an individual who holds a valid current national certification and who has registered with the board as a certified pharmacy technician.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Technical Support Services means the technical support and maintenance Services provided by us according to our then-current technical support policy and procedure listed at xxxxxxxxxxxxx.xxx (“Technical Support Policy”) when the Services are purchased.

  • Kyoto Protocol means the protocol to the UNFCCC adopted at the Third Conference of the Parties to the UNFCCC in Kyoto, Japan on 11 December 1997 as may be amended;

  • 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.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Technical safeguards means the technology and the policy and procedures for its use that 27 protect electronic PHI and control access to it.