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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
7.05Complementary Medicines Registration Application ZA-CTD - QualityV113-Jun-20161 MB
9.72Complementary Medicines submitted for registration - right to saleV124-Apr-2016155 KB
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

eCTD [ 18 ]

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2.21South African Specification for eCTD Regional - Module 1 - showing changesV213-Oct-20161 MB
2.29Implementaion guidance of SA eCTD M1 specification v2.1 & validation criteria v2.1V11.210-Apr-2017114 KB
2.26ZACTD and ZA eCTD Implementation road mapV612-Feb-2016274 KB
2.22South African eCTD Validation CriteriaV22.111-Apr-2017281 KB
2.22South African Validation CriteriaV214-Oct-2016283 KB

General [ 35 ]

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2.06 Biostudies showing changesV606-Jul-20151 MB
2.08AmendmentsV608-Aug-20121 MB
2.25Pharmaceutical and Analytical CTD /eCTDV412-Aug-20141 MB
1.01Guidelines & Forms: Table of ContentsV609-May-2018103 KB
2.39Biological medicines - pre reg - consultation - meeting V102-Mar-2015104 KB

Good Manufacturing Practices [ 12 ]

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4.01SA Guide to Good Manufacturing Practice for MedicinesV629-Dec-2017128 KB
4.03Aerosol ManufacturingV106-Jun-2003129 KB
4.05Cephalosporin manufactureV110-Jun-2003146 KB
4.06Penicillin manufactureV109-Jun-2003146 KB
4.07Radiopharmaceutical manufactureV130-Jun-2015150 KB

Human [ 16 ]

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2.20Package inserts for human medicines standardised texts - showing changesV407-Jul-20151 MB
2.03Alcohol ContentV109-Dec-2003152 KB
2.04Post Importation testingV108-Dec-2003189 KB
2.14Patient information leafletsV406-Jan-2014251 KB
2.14Patient information leaflets showing changesV406-Jan-2014254 KB

Medical Devices and In Vitro Diagnostics [ 7 ]

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8.07Medical Device Quality ManualV201-Aug-2017440 KB
16.03Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDsV11.120-Sep-2016463 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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3.09Reporting of ADR'sV112-Jan-2004134 KB
3.12Veterinary orphan productsV114-May-2012149 KB
3.12Veterinary Orphan ProductsV107-May-2012149 KB
3.06Efficacy of Veterinary biologicsV112-Jan-2004154 KB
3.08Safety of veterinary biologicalsV112-Jan-2004171 KB

[ 1 ]

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