Latest Guidelines Published Notice Board

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-RDN-XR-27Guideline for Users of Ultra-portable X-ray Equipment17/11/20251, Downloadguidelineradiation-control x-rays
SAHPGL-INSP-RC-03Guideline for Destruction of Medicines and Scheduled Substances10/11/20253Downloadguidelineregulatory-compliance
SAHPGL-PEM-05Guideline for Labelling of Medicines Intended for Human Use31/10/20251, Downloadguidelinegeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
SAHPGL-INSP-GMP-02Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q727/10/20251Downloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-HPA-09SAHPRA ECTD Specification 3.1 and Guidance for Module 1 and Regional Information09/10/20254, Downloadguidelinegeneral-ectd-human-medicines-guidelines hpa
SAHPGL-INSP-RC-04Guideline on Traceability of Health Products01/10/20251Downloadguidelineregulatory-compliance
SAHPGL-MD-18Post Market Surveillance and Post-market Clinical Follow-up Studies09/09/20251Downloadguidelinemedical-devices
SAHPGL-MD-16Guidelines on Clinical Evaluation of Medical Devices09/09/20251Downloadguidelinemedical-devices
SAHPGL-MD-17Guideline on Clinical Investigation of Medical Devices09/09/20251Downloadguidelinemedical-devices
SAHPGL-RDN-XR-26Approval of a dosimetry service in South Africa31/01/20252, Downloadguidelineradiation-control x-rays
8.04 (Archived)Recalls Vigilance Medical Devices IVDs14/11/20192Downloadguidelinemedical-devices
GLF-MD-11AMedical Device Adverse Event Reporting Form13/12/20241Downloadguidelinemedical-devices
SAHPGL-MD-11Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)13/12/20241Downloadguidelinemedical-devices
SAHPGL-RDN-INSP-01Guideline for the Sealing and Unsealing of Hazardous Substances19/11/20242, Downloadguidelineinspectorate radiation-control
SAHPGL-CRO-02Guideline on Co-Applicancy16/07/20241Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-LIC-05GWP Guideline for the Importers and Distributors of Scheduled Substances24/04/20241Downloadguidelinelicencing
SAHPGL-RDN-XR-25Guidelines For Users of Electronic Therapeutic Devices Emitting Ionizing Radiation16/01/20241, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-24Guideline for Import Applications of Electronic Devices Emitting Ionizing Radiation13/12/20231, Downloadguidelineradiation-control x-rays
Clinical Trials Committee and Submission Dates for 2024, 12/10/20231, Downloadcommunication-to-industry guidelineclinical-evaluations-management clinical-trials
Medicines Online Directory Toolkit, , , 03/10/20231, Downloadguide guideline presentations toolkitcorporate general-ectd-human-medicines-guidelines
SAHPGL-PEM-VET-04General Information Guideline for Registration of Veterinary Medicines27/06/20234Downloadguidelineveterinary-medicines
SAHPGL-PEM-04International Metric System (SI)23/03/20234Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-MD-07Guideline on Questions and Answers Licensing of Medical Device Establishments, 21/05/20254Downloadfaq guidelinemedical-devices
SAHPGL-CEM-PRE-01Guideline on Co-packaging of Medicines15/02/20231, , Downloadguidelinecem-pre-reg clinical-evaluations-management general-ectd-human-medicines-guidelines
SAHPGL-CEM-PRE-02Guideline for Fixed Dose Combination Products (FDC Products) for HIVAIDS, Tuberculosis and Malaria08/02/20232, , Downloadguidelinecem-pre-reg clinical-evaluations-management general-ectd-human-medicines-guidelines
8.01 (Archived)General Information Medical Devices And IVDs13/08/20141Downloadguidelinemedical-devices
8.06 (Archived)Guideline For Access To And Control Of Medical Devices And IVDs18/04/20171Downloadguidelinemedical-devices
SAHPGL-CEM-PV-03Risk Management Plans for Medicines for Human Use15/09/20221Downloadguidelinepharmacovigilance
SAHPGL-RDN-XR-17Guideline for Disposal of X-Ray Units and Tubes Containing Beryllium17/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-03Guideline for Dental Radiography16/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-23Guideline Radiologist Available by Remote Digital Connection13/09/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-09Guideline For Code Of Practice For Users Of Non – Medical X-RAY Equipment – Forensic25/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-16Guideline for Code of Practise for Industrial Radiography X-Ray31/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-07Guideline for Bone Densitometer – Operators16/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-12Guideline for Monitoring of Radiation workers in a Theatre23/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-04Guideline for Minimum Requirements For Fixed Diagnostic X-Ray Installations17/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-06Guideline For Reducing Radiation Risk From Computer Tomography For Pediatric And Small Adult Patients17/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-02Guideline For Code Of Practice For Users Of Medical Xray Equipment17/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-11General Guidelines with Regards to the Design of X-Ray Rooms23/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-05General Guideline For Cabinet And Conveyer Belt X-ray17/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-08Guideline for Personal Monitoring Med and Vet Use of Diagnostic X-Ray Equipment24/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-13Guideline for QC in Dental Diagnostic X-Ray Imaging Systems31/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-01Guideline for QC in Medical Diagnostic X-Ray Imaging Systems16/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-14Guideline of Test Procedures for Film Processing and Intensifying Screens08/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-18Guidelines on Requests for Medical X-Ray Examinations20/09/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-10Guideline For Radiation Monitoring Requirements And Radiation Occurrences03/08/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-20Guideline for Use of Radiographic Grid Ratio20/09/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-22Guideline for Protective Clothing20/09/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-21Guideline for Patient Dose Measurements in Diagnostic Radiology21/09/20221, Downloadguidelineradiation-control x-rays
SAHPGL-RDN-RN-13Management and Disposal of Non-nuclear Radioactive Waste05/12/20222, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-06 (Old UNSEAL)Guideline For Safe Use of Unsealed Radioactive Nuclides01/02/20241, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-14 (Old TRUG91-1)Guideline For The Safe Transport of Radioactive Material20/02/20242, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-15Identification and Labelling of Radioactive Sources and Source Containers08/02/20242, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-09I-131 Therapy12/12/20222, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-12Reporting National Radiation Occurrences05/12/20222, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-04 (Old IRCP91-2)Guideline for Industrial Radiography18/06/20242, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-08 (Old GAUGE)Guideline For The Safe Use of Industrial Gauges Containing Radioactive Sources01/02/20242, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-01 (Old FIRE)Guideline on Protective Measures To Take In The Event of an Accident Involving Radioactivity01/02/20242, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-XR-15Guideline for Ionising Radiation Dose Limits and Annual Limits on Intake of Radioactive Material23/08/20221, , Downloadguidelineradiation-control radionuclides x-rays
SAHPGL-RDN-RN-03Guideline on The Safe Use of Soil Moisture and Density Gauges Containing Radioactive Sources01/02/20242, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-02Guideline On The Organisational Requirements For Authority Holders And Their Appointed Radiation Protection Officers01/02/20242, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-11RPO Competence and Training Requirements05/12/20222, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-10Leak tests05/12/20223, Downloadguidelineradiation-control radionuclides
SAHGPL-RDN-XR-19Guideline for Management of Pregnant Radiographers and Other Staff Members07/09/20221, , Downloadguidelineradiation-control radionuclides x-rays
SAHPGL-RDN-RN-17Guideline on Requests for Medical Examinations for Radiation Workers20/02/20242, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-05Guideline On Afterloader Source Exchange Forms (RNXM)20/07/20221, Downloadguidelineradiation-control radionuclides
SAHPGL-INSP-RC-13Guideline For Cultivation Of Cannabis10/11/20223, , Downloadguidelinecannabis licencing regulatory-compliance
SAHPGL-PEM-VET-01Guideline on application for use of unregistered veterinary medicines22/03/20243, , , Downloadguidelineemergency-use section-21 unregistered-products veterinary-medicines
Guideline on completion of the veterinary medicines clinical trial application form19/09/20191, , , Downloadguidelineclinical-evaluations-management clinical-trials quality veterinary-medicines
SAHPGL-LIC-03Guideline on How to Amend a Current Licence22/06/20221Downloadguidelinelicencing
SAHPGL-LIC-02Guideline on How to Apply for A Licence to Act as A Wholesaler22/06/20222Downloadguidelinelicencing
SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process12/02/20256, , Downloadguidelinegeneral-ectd-human-medicines-guidelines hpa veterinary-medicines
SAHPGL-INSP-RC-01Guidelines for Post Marketing Surveillance of Medicines and Health Products27/07/20233Downloadguidelineregulatory-compliance
SAHPGL-INSP-RC-11Guideline for Release of Import Health Products at Ports of Entry08/06/20222Downloadguidelineregulatory-compliance
SAHPGL-INSP-RC-07Guidelines for Advertisement of Medicines and Health Products23/06/20222Downloadguidelineregulatory-compliance
SAHPGL-INSP-RC-06 Guideline to Fee Determination and Payments of Permits and Related Authorisations14/06/20221Downloadguidelineregulatory-compliance
SAHPGL-INSP-RC-05Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts15/02/20244Downloadguidelineregulatory-compliance
SAHPGL-CEM-PV-04Post-marketing Reporting of Adverse Drug Reactions for Human Medicines in South Africa22/09/202510Downloadguidelinepharmacovigilance
SAHPGL-PEM-BIO-01Guideline for Lot Release of Human Vaccines08/06/20234Downloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-01Application for rescheduling of a substance or medicine12/05/20221Downloadguidelinenames-and-scheduling
SAHPGL-CEM-PV-02Pharmacovigilance systems06/06/20232Downloadguidelinepharmacovigilance
SAHPGL-CEM-PV-01Pharmacovigilance Inspections for Human Medicinal Products10/05/20221Downloadguidelinepharmacovigilance
SAHPGL-LEG-01Guideline for Appeals Against Regulatory Decisions31/10/20243Downloadguidelinelegal
SAHPGL-PEM-BIO-06General guidance document on QSE for Biological Medicines24/08/20222Downloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-HPA-08Multiple Applications Guideline11/12/20233, Downloadguidelinegeneral-ectd-human-medicines-guidelines hpa
SAHPGL-PEM-VET-02Veterinary Medicines Clinical Guideline13/09/20222, Downloadguidelinequality veterinary-medicines
SAHPGL-PEM-VET-03Veterinary Medicines Exemptions from certain Medicine Registration Requirements26/06/20232, Downloadguidelinequality veterinary-medicines
SAHPGL-FIN-01SAHPRA Payment Guideline12/02/20259Downloadguidelinefinance
SAHPGL-CEM-CT-09Guideline for Clinical Trial Investigators24/10/20223, Downloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-01Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events)05/09/20223, Downloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-06Procedure for Consultation Meetings with Clinical Trial Applicants11/08/20222, Downloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-05Liability Insurance for Clinical Trials17/08/20223, Downloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-02Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model01/07/20222, Downloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-08Guideline for Capacity Building and Transformation in Clinical Research in South Africa01/10/20222, Downloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-04Oversight and Monitoring in Clinical Trials01/08/20224, Downloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-07Post Clinical Trial Access03/08/20224, Downloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-03Emergency Procedures for Clinical Trial Sites17/08/20223, Downloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-10Safety Reporting During Clinical Trials06/10/20225, Downloadguidelineclinical-evaluations-management clinical-trials
SA Good Clinical Practice Guidelines17/06/20203, Downloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-PV-05Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety25/08/20226Downloadguidelinepharmacovigilance