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Guidelines

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Complementary [ 6 ]

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7.01Complementary Medicines - Discipline Specific Safety and EfficacyV313-Jun-20161 MB
7.02Road map for complementary medicines V103-Dec-2013262 KB
7.03Complementary Medicines - Use of the ZA-CTD format in the Preparation of a Registration ApplicationV313-Jun-2016355 KB
7.04Complementary Medicines - Health Supplements Safety & EfficacyV213-Jun-2016966 KB
7.05Complementary Medicines Registration Application ZA-CTD - QualityV113-Jun-20161 MB

eCTD [ 18 ]

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2.21ZA eCTD Module 1 TechnicalV108-Mar-2013967 KB
2.21South African Specification for eCTD Regional - Module 1 - showing changesV213-Oct-20161 MB
2.21South African Specification for eCTD Regional - Module 1V2.115-Nov-2016651 KB
2.22eCTD Validation CriteriaV113-Mar-2013375 KB
2.22South African Validation CriteriaV214-Oct-2016283 KB

General [ 34 ]

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2.01General InformationV801-Aug-2012776 KB
2.02 Pharmaceutical & Analytical V622-Jun-2015725 KB
2.05StabilityV703-Aug-2012524 KB
2.06 Biostudies showing changesV606-Jul-20151 MB
2.06BiostudiesV607-Jul-2015730 KB

Good Manufacturing Practices [ 12 ]

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16.01Guideline - Licence to Manufacture, Import or ExportV127-Feb-2004263 KB
16.02Guideline - Licence to act as a Wholesaler or DistributorV127-Feb-2004278 KB
4.01Guide to Good Manufacturing Practice for Medicines in SAV502-Aug-20105 MB
4.02South African Good Wholesaling Practice for WholesalersV225-Jul-2016743 KB
4.03Aerosol ManufacturingV106-Jun-2003129 KB

Human [ 16 ]

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2.03Alcohol ContentV109-Dec-2003152 KB
2.04Post Importation testingV108-Dec-2003189 KB
2.09Clinical V110-Dec-2003265 KB
2.10Substitution of medicinesV201-Apr-201098 KB
2.11Adverse drug reaction reportingV203-Dec-2012371 KB

Medical Devices and In Vitro Diagnostics [ 7 ]

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16.03Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDsV1.120-Sep-2016463 KB
8.02Medical Devices and IVDs Essential Principles of Safety & Performance showing changesV126-Jul-2016966 KB
8.02 Medical device IVD essential principles - for commentV102-Sep-2014713 KB
8.04Recall, Adverse Event & Post-Marketing Vigilance Reports of Medical Devices & IVDsV201-Aug-2017754 KB
8.05Classification of Medical Devices and IVDsV201-Aug-2017794 KB

Veterinary [ 13 ]

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3.01General Veterinary informationV122-Jun-2015492 KB
3.03Bioavailability and Bioequivalence of Veterinary MedicinesV113-Jan-2014422 KB
3.04Efficacy and GCPV109-Jun-2003275 KB
3.05Preclinical safety for veterinary medicinesV112-Jan-2004269 KB
3.06Efficacy of Veterinary biologicsV112-Jan-2004154 KB

[ 1 ]

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2.33Post-marketing reporting of ADRsV318-Aug-2014484 KB