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Complementary [ 6 ]

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

eCTD [ 18 ]

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2.27 eCTD checksums V101-Mar-201333 KB
2.23 Guidance for the submission of regulatory information in eCTD format V111-Mar-2013737 KB
2.27eCTD checksumsV22.115-Nov-201674 KB
2.22eCTD Validation CriteriaV113-Mar-2013375 KB
2.23Guidance for submission of regulatory information in eCTD formatV22.111-Apr-2017530 KB

General [ 35 ]

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2.06 Biostudies showing changesV606-Jul-20151 MB
2.08AmendmentsV608-Aug-20121 MB
2.08Amendments showing changesV608-Aug-20123 MB
5.03Annual returnsV109-Jun-2003193 KB
2.39Biological medicines - pre reg - consultation - meeting V102-Mar-2015104 KB

Good Manufacturing Practices [ 12 ]

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4.03Aerosol ManufacturingV106-Jun-2003129 KB
4.05Cephalosporin manufactureV110-Jun-2003146 KB
16.02Guideline - Licence to act as a Wholesaler or DistributorV127-Feb-2004278 KB
16.01Guideline - Licence to Manufacture, Import or ExportV127-Feb-2004263 KB
4.09Inspections involving GMP inspectorsV112-Jul-2006166 KB

Human [ 16 ]

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2.11Adverse drug reaction reportingV203-Dec-2012371 KB
2.03Alcohol ContentV109-Dec-2003152 KB
2.09Clinical V110-Dec-2003265 KB
2.31Fixed dosage combination products for HIV, AIDS, TB, MalariaV201-Aug-2012309 KB
2.16Package insert - human medicinesV506-Jan-2014351 KB

Medical Devices and In Vitro Diagnostics [ 7 ]

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8.05Classification of Medical Devices and IVDsV201-Aug-2017794 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
8.07Medical Device Quality ManualV201-Aug-2017440 KB
8.02Medical Devices and IVDs Essential Principles of Safety & Performance showing changesV126-Jul-2016966 KB

Veterinary [ 13 ]

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3.03Bioavailability and Bioequivalence of Veterinary MedicinesV113-Jan-2014422 KB
3.11Completing section 21 application formV112-Jan-2004284 KB
3.04Efficacy and GCPV109-Jun-2003275 KB
3.06Efficacy of Veterinary biologicsV112-Jan-2004154 KB
3.01General Veterinary informationV122-Jun-2015492 KB

[ 1 ]

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