Betekenis van:
master file

Voorbeeldzinnen

1. THE TRIAL MASTER FILE AND ARCHIVING
2. maintain and make available on request a pharmacovigilance system master file;
3. a reference to the location where the pharmacovigilance system master file for the medicinal product is kept.’,
4. Scientific guidelines for the submission and evaluation of a vaccine antigen master file shall be adopted by the Agency.
5. A “full inspection report” comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate.
6. The national competent authority may at any time ask the marketing authorisation holder to submit a copy of the pharmacovigilance system master file.
7. 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.
8. 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.
9. 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.
10. 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.
11. He shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings, ensure that an appropriate corrective action plan is prepared and implemented.
12. The procedure for the submission and evaluation of a vaccine antigen master file shall follow the guidance published by the Commission in The rules governing medicinal products in the European Union, Volume 6B, Notice to Applicants.
13. inspect the premises, records, documents and pharmacovigilance system master file of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform the activities described in Title IX.’;
14. For the purpose of this Annex, a Vaccine Antigen Master File means a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information on quality concerning each of the active substances, which are part of this veterinary medicinal product.
15. The documentation referred to Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.