Betekenis van:
master file

master file
Zelfstandig naamwoord
    • (computer science) a computer file that is used as the authority in a given job and that is relatively permanent

    Synoniemen

    Hyperoniemen


    Voorbeeldzinnen

    1. VACCINE ANTIGEN MASTER FILE
    2. THE TRIAL MASTER FILE AND ARCHIVING
    3. All variations in the group are changes to an Active Substance Master File, Vaccine Antigen Master File or Plasma Master File.
    4. the content and maintenance of the pharmacovigilance system master file kept by the marketing authorisation holder;
    5. maintain and make available on request a pharmacovigilance system master file;
    6. a reference to the location where the pharmacovigilance system master file for the medicinal product is kept.’,
    7. Scientific guidelines for the submission and evaluation of a vaccine antigen master file shall be adopted by the Agency.
    8. Pharmacovigilance system master file A detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products.’.
    9. A “full inspection report” comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate.
    10. The national competent authority may at any time ask the marketing authorisation holder to submit a copy of the pharmacovigilance system master file.
    11. The trial master file shall provide the basis for the audit by the sponsor’s independent auditor and for the inspection by the competent authority.
    12. The marketing authorisation holder should establish a pharmacovigilance system to ensure the monitoring and supervision of one or more of its authorised medicinal products, recorded in a pharmacovigilance system master file which should be permanently available for inspection.
    13. Documents and particulars supporting the application for such a change shall be supplied to the competent authorities those documents and particulars shall also be supplied to the applicant where they concern the applicant’s part of the Active Substance Master File.
    14. For particular immunological veterinary medicinal products and by derogation from the provisions of Title II, Part 2 Section C on active substances, the concept of a Vaccine Antigen Master File is introduced.
    15. A “full inspection report” comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A “detailed report” responds to specific queries about a firm by the other Party.