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Complementary [ 6 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	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
	2.22	South African eCTD Validation Criteria	V2	2.1	11-Apr-2017	281 KB
	2.23	Guidance for the submission of regulatory information in eCTD format	V1		11-Mar-2013	737 KB
	2.23	Guidance for the submission of regulatory information in eCTD format	V2		12-Oct-2016	854 KB
	2.23	Guidance for the submission of regulatory information in eCTD format – showing changes	V2		13-Oct-2016	862 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	V6		07-Jul-2015	730 KB
	2.07	Dissolution	V5		16-Jul-2015	353 KB
	2.07	Dissolution showing changes	V5		16-Jul-2015	278 KB
	2.08	Amendments showing changes	V6		08-Aug-2012	3 MB
	2.08	Amendments	V6		08-Aug-2012	1 MB

Good Manufacturing Practices [ 12 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	4.04	Isolator technology	V1		10-Jun-2003	201 KB
	4.05	Cephalosporin manufacture	V1		10-Jun-2003	146 KB
	4.06	Penicillin manufacture	V1		09-Jun-2003	146 KB
	4.07	Radiopharmaceutical manufacture	V1		30-Jun-2015	150 KB
	4.08	Site master file	V2		04-Oct-2010	240 KB

Human [ 16 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	2.14	Patient information leaflets	V4		06-Jan-2014	251 KB
	2.14	Patient information leaflets showing changes	V4		06-Jan-2014	254 KB
	2.16	Package insert – human medicines	V5		06-Jan-2014	351 KB
	2.16	Package insert – human medicines – showing changes	V5		06-Jan-2014	690 KB
	2.17	Safety-related Package Insert Notifications (SR-PINs)	V3		04-Aug-2017	81 KB

Medical Devices and In Vitro Diagnostics [ 7 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	8.07	Medical Device Quality Manual	V2		01-Aug-2017	440 KB
	8.10	Questions & Answers: Licensing of Medical Device Establishments	V1		29-Dec-2017	97 KB

Veterinary [ 13 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	3.07	MRL and withdrawal periods	V1		12-Jan-2004	608 KB
	3.08	Safety of veterinary biologicals	V1		12-Jan-2004	171 KB
	3.09	Reporting of ADR's	V1		12-Jan-2004	134 KB
	3.10	Recall of veterinary medicines	V1		12-Jan-2004	269 KB
	3.11	Completing section 21 application form	V1		12-Jan-2004	284 KB

[ 1 ]

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