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Safety-related Package Insert Notifications (SR PINS) in South Africa.Circular 2.17.
Notice to the pharmaceutical industry on process for addressing the backlog in evaluation of registration applications. Dossier is will be reviewed by work groups attending 2 different categories of document.
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
Draft regulations to the Medicines Act have been published for a comment period of 3 months. Commentary is due by the 26th April 2017. The draft regulations include the complementary medicines regulations. Medical device-specific regulations (finalised) are published…