Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting

Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting

For over a decade, ADR reports have been submitted to the National Adverse Drug Events Monitoring Centre (NADEMC) via fax. These reports were previously captured on the ADRI database. The ADRI database restricted electronic reporting by both applicants and healthcare professionals, and direct uploading of information onto the international database of the WHO Uppsala Monitoring Centre' VigiBase®. This feature forms part of the VigiFlow® software used to record ADR reports received.

2022 Aug

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Version: 1
Date Updated: 18/08/2022
File Type: pdf
Category: Communication to industry
Unit: Pharmacovigilance