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Guidelines

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Complementary [ 6 ]

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7.05Complementary Medicines Registration Application ZA-CTD - QualityV113-Jun-20161 MB
7.03Complementary Medicines - Use of the ZA-CTD format in the Preparation of a Registration ApplicationV313-Jun-2016355 KB
7.01Complementary Medicines - Discipline Specific Safety and EfficacyV313-Jun-20161 MB
7.04Complementary Medicines - Health Supplements Safety & EfficacyV213-Jun-2016966 KB
9.72Complementary Medicines submitted for registration - right to saleV124-Apr-2016155 KB

eCTD [ 18 ]

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2.28Questions & Answers - Implementation of eCTD in South AfricaV430-May-2019361 KB
2.21SA Specification for eCTD Regional - Module 1 showing changesV330-May-2019523 KB
2.21SA Specification for eCTD Regional - Module 1V330-May-2019519 KB
2.22South African eCTD Validation CriteriaV22.111-Apr-2017281 KB
2.23Guidance for submission of regulatory information in eCTD formatV22.111-Apr-2017530 KB

General [ 35 ]

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2.40Multiple submissions of the same application with different proprietary namesV430-May-2019340 KB
1.01Guidelines & Forms Table of ContentsV1030-May-2019105 KB
2.24Guidance for the submission of the South African CTD/eCTD - General & Module 1V630-May-2019303 KB
2.38International metric system V329-Mar-201927 KB
2.44Cultivation of Cannabis & Manufacture of Cannabis-related Pharmaceutical Products for medicinal and research purposesV206-Nov-2017299 KB

Good Manufacturing Practices [ 12 ]

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4.01SA Guide to Good Manufacturing Practice for MedicinesV629-Dec-2017128 KB
4.02South African Good Wholesaling Practice for WholesalersV225-Jul-2016743 KB
4.10Wholesalers to Export Medicinal ProductsV117-May-2016210 KB
4.07Radiopharmaceutical manufactureV130-Jun-2015150 KB
4.08Site master fileV204-Oct-2010240 KB

Human [ 18 ]

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1Good clinical practice guideline- mFor commentV11.115-Jul-20191 MB
1Biological Medicines Amendments GuidelinesV11.119-Jun-20191 MB
2.17Safety-related Package Insert Notifications (SR-PINs) showing changesV304-Aug-201793 KB
2.17Safety-related Package Insert Notifications (SR-PINs)V304-Aug-201781 KB
2.33Post-marketing reporting of ADRs to human medicines in South AfricaV519-Jun-2017634 KB

Medical Devices and In Vitro Diagnostics [ 7 ]

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8.10Questions & Answers: Licensing of Medical Device EstablishmentsV129-Dec-201797 KB
8.05Classification of Medical Devices and IVDsV201-Aug-2017794 KB
8.07Medical Device Quality ManualV201-Aug-2017440 KB
8.04Recall, Adverse Event & Post-Marketing Vigilance Reports of Medical Devices & IVDsV201-Aug-2017754 KB
16.03Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDsV11.120-Sep-2016463 KB

Veterinary [ 13 ]

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3.01General Veterinary informationV122-Jun-2015492 KB
3.03Bioavailability and Bioequivalence of Veterinary MedicinesV113-Jan-2014422 KB
3.13Veterinary Antimastitis ProductsV104-Nov-2013343 KB
3.12Veterinary orphan productsV114-May-2012149 KB
3.12Veterinary Orphan ProductsV107-May-2012149 KB

[ 1 ]

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