Publications

Guidelines

Search Documents

Email and Download Multiple Documents

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
	7.05	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
	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

eCTD [ 18 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	2.21	South African Specification for eCTD Regional – Module 1 – showing changes	V2		13-Oct-2016	1 MB
	2.29	Implementaion guidance of SA eCTD M1 specification v2.1 & validation criteria v2.1	V1	1.2	10-Apr-2017	114 KB
	2.26	ZACTD and ZA eCTD Implementation road map	V6		12-Feb-2016	274 KB
	2.22	South African eCTD Validation Criteria	V2	2.1	11-Apr-2017	281 KB
	2.22	South African Validation Criteria	V2		14-Oct-2016	283 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
	2.25	Pharmaceutical and Analytical CTD /eCTD	V4		12-Aug-2014	1 MB
	1.01	Guidelines & Forms: Table of Contents	V6		09-May-2018	103 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
	4.01	SA Guide to Good Manufacturing Practice for Medicines	V6		29-Dec-2017	128 KB
	4.03	Aerosol Manufacturing	V1		06-Jun-2003	129 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

Human [ 16 ]

Type	Doc#	Title	Version	SubVersion	PublishDate	Size	Select
	2.20	Package inserts for human medicines standardised texts – showing changes	V4		07-Jul-2015	1 MB
	2.03	Alcohol Content	V1		09-Dec-2003	152 KB
	2.04	Post Importation testing	V1		08-Dec-2003	189 KB
	2.14	Patient information leaflets	V4		06-Jan-2014	251 KB
	2.14	Patient information leaflets showing changes	V4		06-Jan-2014	254 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
	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
	8.04	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
	3.09	Reporting of ADR's	V1		12-Jan-2004	134 KB
	3.12	Veterinary orphan products	V1		14-May-2012	149 KB
	3.12	Veterinary Orphan Products	V1		07-May-2012	149 KB
	3.06	Efficacy of Veterinary biologics	V1		12-Jan-2004	154 KB
	3.08	Safety of veterinary biologicals	V1		12-Jan-2004	171 KB

[ 1 ]

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