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Safety-related Package Insert Notifications (SR PINS) in South Africa.Circular 2.17.
This is a draft guideline incorporating medical devices. Not yet finalised
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
POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA (MCC: June 2017)
Post-Marketing Reporting of Adverse Drug Reactions to Human Medicines in South Africa