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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
	7.04	Complementary Medicines – Health Supplements Safety & Efficacy	V2		13-Jun-2016	966 KB
	7.03	Complementary Medicines – Use of the ZA-CTD format in the Preparation of a Registration Application	V3		13-Jun-2016	355 KB
	7.05	Complementary Medicines Registration Application ZA-CTD – Quality	V1		13-Jun-2016	1 MB
	9.72	Complementary Medicines submitted for registration – right to sale	V1		24-Apr-2016	155 KB

eCTD [ 18 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	2.27	eCTD checksums	V1		01-Mar-2013	33 KB
	2.23	Guidance for the submission of regulatory information in eCTD format	V1		11-Mar-2013	737 KB
	2.27	eCTD checksums	V2	2.1	15-Nov-2016	74 KB
	2.22	eCTD Validation Criteria	V1		13-Mar-2013	375 KB
	2.23	Guidance for submission of regulatory information in eCTD format	V2	2.1	11-Apr-2017	530 KB

General [ 35 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	2.06	Biostudies showing changes	V6		06-Jul-2015	1 MB
	2.08	Amendments	V6		08-Aug-2012	1 MB
	2.08	Amendments showing changes	V6		08-Aug-2012	3 MB
	5.03	Annual returns	V1		09-Jun-2003	193 KB
	2.39	Biological medicines – pre reg – consultation – meeting	V1		02-Mar-2015	104 KB

Good Manufacturing Practices [ 12 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	4.03	Aerosol Manufacturing	V1		06-Jun-2003	129 KB
	4.05	Cephalosporin manufacture	V1		10-Jun-2003	146 KB
	16.02	Guideline – Licence to act as a Wholesaler or Distributor	V1		27-Feb-2004	278 KB
	16.01	Guideline – Licence to Manufacture, Import or Export	V1		27-Feb-2004	263 KB
	4.09	Inspections involving GMP inspectors	V1		12-Jul-2006	166 KB

Human [ 16 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	2.11	Adverse drug reaction reporting	V2		03-Dec-2012	371 KB
	2.03	Alcohol Content	V1		09-Dec-2003	152 KB
	2.09	Clinical	V1		10-Dec-2003	265 KB
	2.31	Fixed dosage combination products for HIV, AIDS, TB, Malaria	V2		01-Aug-2012	309 KB
	2.16	Package insert – human medicines	V5		06-Jan-2014	351 KB

Medical Devices and In Vitro Diagnostics [ 7 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	8.05	Classification of Medical Devices and IVDs	V2		01-Aug-2017	794 KB
	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 device IVD essential principles – for comment	V1		02-Sep-2014	713 KB
	8.07	Medical Device Quality Manual	V2		01-Aug-2017	440 KB
	8.02	Medical Devices and IVDs Essential Principles of Safety & Performance showing changes	V1		26-Jul-2016	966 KB

Veterinary [ 13 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	3.03	Bioavailability and Bioequivalence of Veterinary Medicines	V1		13-Jan-2014	422 KB
	3.11	Completing section 21 application form	V1		12-Jan-2004	284 KB
	3.04	Efficacy and GCP	V1		09-Jun-2003	275 KB
	3.06	Efficacy of Veterinary biologics	V1		12-Jan-2004	154 KB
	3.01	General Veterinary information	V1		22-Jun-2015	492 KB

[ 1 ]

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