Reporting ADRs CIOMS

The MA holder has to keep records on all severe ADRs that en-e reported to him by a healthcare professional in Belgium or outside the European Union. Within 15 days he or she has to report ADRs to the Minister (pharmaceutical inspection). It is recommended to use the CIOMS document to indicate the clinical data it also has to be indicated whether the ADR is already mentioned in the approved leeiflet. For products approved by the central procedure, these data have to be reported immediately to the EMEA within 15 days. [Pg.62]

Faich GA, Castle W, Bankowski Z, and the Council for International Organizations of Medical Sciences (CIOMS) ADR Working Group. 1990. International adverse drug reporting. The CIOMS project. J. Clin. Res. Pharmacoepidemiol. 4 83-90. [Pg.543]

CIOMS Council for International Organisations of Medical Sciences (postapproval international ADR reporting, UK)... [Pg.528]

International standards for ADR reporting have been developed since the late 1980s through the Council for the International Organisation of Medical Sciences (CIOMS) and International Conference on Harmonisation (ICH) - see Chapter 6. [Pg.36]

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