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Complementary [ 6 ]

Type	Doc#	Title	Version	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	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	V2.1	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 [ 33 ]

Type	Doc#	Title	Version	PublishDate	Size	Select
	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
	2.06	Biostudies	V6	07-Jul-2015	730 KB

Good Manufacturing Practices [ 12 ]

Type	Doc#	Title	Version	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	Guide to Good Manufacturing Practice for Medicines in SA	V5	02-Aug-2010	5 MB
	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	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	PublishDate	Size	Select
	16.03	Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs	V1.1	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	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	PublishDate	Size	Select
	2.33	Post-marketing reporting of ADRs	V3	18-Aug-2014	484 KB