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Post-Marketing Reporting of Adverse Drug Reactions to Human Medicinal Products in South Africa (MCC: 2.33, Sept 2016)
The document assist the reporting of adverse drug reactions (ADRs) and in the management of safety data during post-registration and post-marketing clinical trials. To confirm that you have the latest version of this document, please visit: http://www.mccza.com
This guideline supplements the guideline on oversight and monitoring of clinical trials to clarify and define the rules of investigators in investigational studies of medical products.
Recommendations for an application for a licence to manufacture, import or export medicines and medical devices. GWP guidelines apply.