Betekenis van:
file system

Voorbeeldzinnen

1. maintain and make available on request a pharmacovigilance system master file;
2. a reference to the location where the pharmacovigilance system master file for the medicinal product is kept.’,
3. For the processing of case related personal data, Eurojust may not establish any automated data file other than the Case Management System.
4. The national competent authority may at any time ask the marketing authorisation holder to submit a copy of the pharmacovigilance system master file.
5. If necessary, run the initial operating system setup and allow all preliminary file indexing and other one-time/periodic processes to complete.
6. 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.
7. If the Cebamail system is not operational for the file transfer of FVC updates or corrections, NCBs shall transfer these files by e-mail using the XML format to the following e-mail address: [email protected]
8. Then, the air navigation service provider shall draw up the EC declaration of verification of system and submit it to the national supervisory authority together with the technical file as requested by Article 6 of the interoperability Regulation.
9. Since, with online access, it is not possible for the Member State administering the file to make any prior checks, a system ensuring post hoc monitoring should be in place.
10. 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.’;
11. The national competent authorities shall draw up an assessment report and make comments on the file as regards the results of the pharmaceutical and pre-clinical tests, the clinical trials, the risk management system and the pharmacovigilance system of the medicinal product concerned.
12. The migration of the national system from SIS 1+ to SIS II consists of the data loading of N.SIS II, when that N.SIS II is to contain a data file, the national copy, containing a complete or partial copy of the SIS II database, followed by a switchover from N.SIS to N.SIS II for each Member State.
13. a national system (N.SIS II) in each of the Member States, consisting of the national data systems which communicate with the Central SIS II. An N.SIS II may contain a data file (a national copy), containing a complete or partial copy of the SIS II database;
14. In the case of data from national DNA analysis files and automated dactyloscopic identification systems, a hit/no hit system should enable the searching Member State, in a second step, to request specific related personal data from the Member State administering the file and, where necessary, to request further information through mutual assistance procedures, including those adopted pursuant to Framework Decision 2006/960/JHA.
15. a national system (N.SIS II) in each of the Member States, consisting of the national data systems which communicate with Central SIS II. An N.SIS II may contain a data file (a ‘national copy’), containing a complete or partial copy of the SIS II database;