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Complementary [ 6 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	7.01	Complementary Medicines - Discipline Specific Safety and Efficacy	V3		13-Jun-2016	1 MB
	7.02	Road map for complementary medicines	V1		03-Dec-2013	262 KB
	7.03	Complementary Medicines - Use of the ZA-CTD format in the Preparation of a Registration Application	V3		13-Jun-2016	355 KB
	7.04	Complementary Medicines - Health Supplements Safety & Efficacy	V2		13-Jun-2016	966 KB
	7.05	Complementary Medicines Registration Application ZA-CTD - Quality	V1		13-Jun-2016	1 MB

eCTD [ 18 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	2.21	ZA eCTD Module 1 Technical	V1		08-Mar-2013	967 KB
	2.21	South African Specification for eCTD Regional - Module 1 - showing changes	V2		13-Oct-2016	1 MB
	2.21	South African Specification for eCTD Regional - Module 1	V2	2.1	15-Nov-2016	651 KB
	2.22	eCTD Validation Criteria	V1		13-Mar-2013	375 KB
	2.22	South African Validation Criteria	V2		14-Oct-2016	283 KB

General [ 35 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	1.01	Guidelines and Forms: Table of Contents	V9		30-Apr-2019	105 KB
	2.01	General Information	V8		01-Aug-2012	776 KB
	2.02	Pharmaceutical & Analytical	V6		22-Jun-2015	725 KB
	2.05	Stability	V7		03-Aug-2012	524 KB
	2.06	Biostudies showing changes	V6		06-Jul-2015	1 MB

Good Manufacturing Practices [ 12 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	16.01	Guideline - Licence to Manufacture, Import or Export	V1		27-Feb-2004	263 KB
	16.02	Guideline - Licence to act as a Wholesaler or Distributor	V1		27-Feb-2004	278 KB
	4.01	SA Guide to Good Manufacturing Practice for Medicines	V6		29-Dec-2017	128 KB
	4.02	South African Good Wholesaling Practice for Wholesalers	V2		25-Jul-2016	743 KB
	4.03	Aerosol Manufacturing	V1		06-Jun-2003	129 KB

Human [ 16 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	2.03	Alcohol Content	V1		09-Dec-2003	152 KB
	2.04	Post Importation testing	V1		08-Dec-2003	189 KB
	2.09	Clinical	V1		10-Dec-2003	265 KB
	2.10	Substitution of medicines	V2		01-Apr-2010	98 KB
	2.11	Adverse drug reaction reporting	V2		03-Dec-2012	371 KB

Medical Devices and In Vitro Diagnostics [ 7 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	16.03	Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs	V1	1.1	20-Sep-2016	463 KB
	8.02	Medical Devices and IVDs Essential Principles of Safety & Performance showing changes	V1		26-Jul-2016	966 KB
	8.02	Medical device IVD essential principles - for comment	V1		02-Sep-2014	713 KB
	8.04	Recall, Adverse Event & Post-Marketing Vigilance Reports of Medical Devices & IVDs	V2		01-Aug-2017	754 KB
	8.05	Classification of Medical Devices and IVDs	V2		01-Aug-2017	794 KB

Veterinary [ 13 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	3.01	General Veterinary information	V1		22-Jun-2015	492 KB
	3.03	Bioavailability and Bioequivalence of Veterinary Medicines	V1		13-Jan-2014	422 KB
	3.04	Efficacy and GCP	V1		09-Jun-2003	275 KB
	3.05	Preclinical safety for veterinary medicines	V1		12-Jan-2004	269 KB
	3.06	Efficacy of Veterinary biologics	V1		12-Jan-2004	154 KB

[ 1 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	2.33	Post-marketing reporting of ADRs	V3		18-Aug-2014	484 KB