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16.04Licence to act as a Wholesaler of Medical Devices & IVDsV103-Aug-2017103 KB
2.04Post-importation TestingV220-Jan-2017526 KB
2.04Post-importation testing showing changesV220-Jan-2017509 KB
2.11Safety Reporting during Clinical Trials in South AfricaV220-Aug-2016424 KB
2.40Clinical Trial Oversight, Monitoring of Clinical TrialsV110-May-2016162 KB
2.42Post Clinical Trial Drug AccessV110-May-201698 KB
2.45Borderline ProductsV130-Mar-2017795 KB
2.46Co-packaging of MedicinesV105-May-201793 KB
2.48Exemptions from certain medicine registration requirements for Human Medicines - for commentV130-Dec-201799 KB
2.49Capacity Building and Transformation in Clinical Trials Research in South AfricaV110-Mar-201899 KB
2.50Medicines and Human Reproduction for commentV102-May-2018286 KB
2.52Section 21 - Access to Unregistered MedicinesV130-Apr-2019147 KB
2.53Investigator Workload in Clinical Trial for commentV102-May-2019100 KB
5.07Guideline for recall / withdrawal of Medicines, Medical devices and IVDs - for commentV421-Sep-2015314 KB
5.07 Guideline for recall / withdrawal of Medicines, Medical devices and IVDs - showing changesV421-Sep-2015316 KB
6.1.aBiological AmendmentsV119-Jun-20171 MB
7.04Complementary Medicines - Health Supplements Safety & EfficacyV312-Apr-2017680 KB
7.04Complementary Medicines Health Supplements Safety & Efficacy Annexure JV33.130-May-2017408 KB
7.04Complementary Medicines Health Supplements Safety and Efficacy Annexures H, K, L for commentV33.206-May-2019383 KB
7.06Complementary Medicines - Caffeine and MentholV112-Apr-2017100 KB