Adverse Drug Reactions to Human Medicines in South Africa

South Africa – POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA

  • The South African MCC (Medicines Control Council) has issued a revised version of the guideline (November 2016) covering Post-Marketing Safety Reporting, which was implemented in September 2016, the update clarifies that:

  • the requirements do not apply to unregistered medicines

  • the applicant needs to specify and communicate to the authorities the 12-month period he decides to use for the Summary Evaluation Statement, which must be submitted within 90 days of the Data Lock Point

The guideline can be located at: http://www.mccza.com/Publications/Index/1

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