15 Jun Post-marketing Reporting of Adverse Drug Reactions for Human Medicines in South Africa
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This guideline is intended to assist Applicants/ HCRs in the reporting of ADRs/AEFIs associated with the use of health products, as provided for in the scope, and in the management of safety data which may arise during post-registration, including during Phase 4 post-marketing clinical trials.
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Document Number:
SAHPGL-CEM-PV-04
Version:
10
Date Updated:
22/09/2025
File Type:
pdf
Category:
Guideline