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Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
Clinical Trials Committee and Submission Dates for 2024, 12/10/20231, pdfDownloadcommunication-to-industry guidelineclinical-evaluations-management clinical-trials
Medicines Online Directory Toolkit, , , 03/10/20231, wwwDownloadguide guideline presentations toolkitcorporate general-ectd-human-medicines-guidelines
SAHPGL-PEM-VET-04General Information Guideline for Registration of Veterinary Medicines27/06/20234pdfDownloadguidelineveterinary-medicines
2.24Guidance For The Submission Of The South African CTD-eCTD – General & Module15/05/20196Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-04International Metric System (SI)23/03/20234pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-MD-07Guideline on Questions and Answers Licensing of Medical Device Establishments, 17/11/20233pdfDownloadfaq guidelinemedical-devices
SAHPGL-CEM-PRE-01Guideline on Co-packaging of Medicines15/02/20231, , pdfDownloadguidelinecem-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, , pdfDownloadguidelinecem-pre-reg clinical-evaluations-management general-ectd-human-medicines-guidelines
8.01General Information Medical Devices And IVDs13/08/20141Downloadguidelinemedical-devices
8.06Guideline For Access To And Control Of Medical Devices And IVDs18/04/20171Downloadguidelinemedical-devices
SAHPGL-CEM-PV-03Risk Management Plans for Medicines for Human Use15/09/20221pdfDownloadguidelinepharmacovigilance
SAHPGL-RDN-XR-17Guideline for Disposal of X-Ray Units and Tubes Containing Beryllium17/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-03Guideline for Dental Radiography16/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-23Guideline Radiologist Available by Remote Digital Connection13/09/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-09Guideline For Code Of Practice For Users Of Non – Medical X-RAY Equipment – Forensic25/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-16Guideline for Code of Practise for Industrial Radiography X-Ray31/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-07Guideline for Bone Densitometer – Operators16/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-12Guideline for Monitoring of Radiation workers in a Theatre23/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-04Guideline for Minimum Requirements For Fixed Diagnostic X-Ray Installations17/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-06Guideline For Reducing Radiation Risk From Computer Tomography For Pediatric And Small Adult Patients17/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-02Guideline For Code Of Practice For Users Of Medical Xray Equipment17/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-11General Guidelines with Regards to the Design of X-Ray Rooms23/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-05General Guideline For Cabinet And Conveyer Belt X-ray17/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-08Guideline for Personal Monitoring Med and Vet Use of Diagnostic X-Ray Equipment24/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-13Guideline for QC in Dental Diagnostic X-Ray Imaging Systems31/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-01Guideline for QC in Medical Diagnostic X-Ray Imaging Systems16/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-14Guideline of Test Procedures for Film Processing and Intensifying Screens08/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-18Guidelines on Requests for Medical X-Ray Examinations20/09/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-10Guideline For Radiation Monitoring Requirements And Radiation Occurrences03/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-20Guideline for Use of Radiographic Grid Ratio20/09/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-22Guideline for Protective Clothing20/09/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-21Guideline for Patient Dose Measurements in Diagnostic Radiology21/09/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-RN-13Management and Disposal of Non-nuclear Radioactive Waste05/12/20222, pdfDownloadguidelineradiation-control radionuclides
UNSEALSafe use of unsealed radioactive nuclides20/02/20012, Downloadguidelineradiation-control radionuclides
TRUG91-1Safe transport of radioactive material17/05/20062, Downloadguidelineradiation-control radionuclides
RN-REQ-SRC-001Label sources & containers17/07/20141, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-09I-131 Therapy12/12/20222, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-12Reporting National Radiation Occurrences05/12/20222, pdfDownloadguidelineradiation-control radionuclides
IRCP91-2Industrial radiography (gamma radiography)09/05/20192, Downloadguidelineradiation-control radionuclides
GAUGECode of Practice for the safe use of industrial gauges containing radioactive sources09/05/20192, Downloadguidelineradiation-control radionuclides
FIREProtective measures to take in the event of an accident involving radioactivity07/02/20012, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-XR-15Guideline for Ionising Radiation Dose Limits and Annual Limits on Intake of Radioactive Material23/08/20221, , pdfDownloadguidelineradiation-control radionuclides x-rays
Code of Practice – Safe use of soil moisture and density gauges25/07/20195, Downloadguidelineradiation-control radionuclides
Guidelines Regarding Organisational Requirements For Authority Holders And Their Appointed Radiation Protection Officers In Respect Of Group Iv Hazardous Substances23/07/20092, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-11RPO Competence and Training Requirements05/12/20222, pdfDownloadguidelineradiation-control radionuclides
Licensing Requirements For New Nuclear Medicine Practices25/09/20142, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-10Leak tests05/12/20223, pdfDownloadguidelineradiation-control radionuclides
Internal rules – Minimum requirements23/07/20092, Downloadguidelineradiation-control radionuclides
SAHGPL-RDN-XR-19Guideline for Management of Pregnant Radiographers and Other Staff Members07/09/20221, , pdfDownloadguidelineradiation-control radionuclides x-rays
Medical Examinations For Radiation Workers16/07/20092, Downloadguidelineradiation-control radionuclides
2.21South African Specification for eCTD Regional Module130/05/20193Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-RDN-RN-05Guideline On Afterloader Source Exchange Forms (RNXM)20/07/20221, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-INSP-RC-13Guideline For Cultivation Of Cannabis10/11/20223, , pdfDownloadguidelinecannabis licencing regulatory-compliance
SAHPGL-PEM-VET-01Guideline on application for use of unregistered veterinary medicines09/08/20223, , , pdfDownloadguidelineemergency-use section-21 unregistered-products veterinary-medicines
Guideline on completion of the veterinary medicines clinical trial application form19/09/20191, , Downloadguidelineclinical-trials quality veterinary-medicines
SAHPGL-LIC-03Guideline on How to Amend a Current Licence22/06/20221pdfDownloadguidelinelicencing
SAHPGL-LIC-02Guideline on How to Apply for A Licence to Act as A Wholesaler22/06/20222pdfDownloadguidelinelicencing
SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process11/07/20233, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa veterinary-medicines
SAHPGL-INSP-RC-01Guidelines for Post Marketing Surveillance of Medicines and Health Products27/07/20233pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-11Guideline for Release of Import Health Products at Ports of Entry08/06/20222pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-07Guidelines for Advertisement of Medicines and Health Products23/06/20222pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-06 Guideline to Fee Determination and Payments of Permits and Related Authorisations14/06/20221pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-05Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts06/06/20223pdfDownloadguidelineregulatory-compliance
SAHPGL-CEM-PV-04Post-marketing Reporting Of Adverse Drug Reactions To Human Medicines In South Africa08/06/20229pdfDownloadguidelinepharmacovigilance
SAHPGL-PEM-BIO-01Guideline for Lot Release of Human Vaccines08/06/20234pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-01Application for rescheduling of a substance or medicine12/05/20221pdfDownloadguidelinenames-and-scheduling
SAHPGL-CEM-PV-02Pharmacovigilance systems06/06/20232pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-01Pharmacovigilance Inspections for Human Medicinal Products10/05/20221pdfDownloadguidelinepharmacovigilance
SAHPGL-GOV-01Guideline for appeals against Regulatory decisions13/04/20221pdfDownloadguidelinequality-management-system
SAHPGL-PEM-BIO-06General guidance document on QSE for Biological Medicines24/08/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
2.40Multiple submissions of the same application for registration with different proprietary names23/05/20194Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-VET-02Veterinary Medicines Clinical Guideline13/09/20222, pdfDownloadguidelinequality veterinary-medicines
SAHPGL-PEM-VET-03Veterinary Medicines Exemptions from certain Medicine Registration Requirements26/06/20232, pdfDownloadguidelinequality veterinary-medicines
17.05SAHPRA Payment Guideline15/09/20227pdfDownloadguidelinefinance
SAHPGL-CEM-CT-09Guideline for Clinical Trial Investigators, 24/10/20223pdfDownloadcommunication-to-industry guidelineclinical-trials
SAHPGL-CEM-CT-01Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events), 05/09/20223pdfDownloadcommunication-to-industry guidelineclinical-trials
SAHPGL-CEM-CT-06Procedure for Consultation Meetings with Clinical Trial Applicants11/08/20222pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-05Liability Insurance for Clinical Trials17/08/20223pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-02Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model01/07/20222pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-08Guideline for Capacity Building and Transformation in Clinical Research in South Africa01/10/20222pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-04Oversight and Monitoring in Clinical Trials01/08/20224pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-07Post Clinical Trial Access03/08/20224pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-03Emergency Procedures for Clinical Trial Sites17/08/20223pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-10Safety Reporting During Clinical Trials06/10/20225pdfDownloadguidelineclinical-trials
SA Good Clinical Practice Guidelines17/06/20203pdfDownloadguidelineclinical-trials
SAHPGL-CEM-PV-05Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety25/08/20226pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-06Guideline For Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals18/08/20223pdfDownloadguidelinepharmacovigilance
SAHPGL-INSP-RC-12Guideline On How To Lodge A Complaint On Medicines And Medical Devices10/11/20224pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-02Guideline for the Importation and Exportation of Medicines08/06/20222pdfDownloadguidelineregulatory-compliance
SAHPGL-LIC-01Licence to Manufacture, Import or Export09/06/20223pdfDownloadguidelinelicencing
SAHPGL-INSP-06Guideline for Fee determination and Payment of GxP and Product related Inspection14/09/20222pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-05Guideline on how to respond to a GMP, GWP, GCP and GVP Inspection report21/09/20222pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-04Guideline for preparation of site master file14/09/20225, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-03Guideline for Good Wholesaling Practice for Wholesaler07/09/20225, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-01Guideline for Post Importation Testing15/09/20225pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-CEM-S21-02Guideline For Section 21 Access To Unregistered Medicines05/08/20224, , pdfDownloadguidelineemergency-use section-21 unregistered-products
Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME, 19/05/20222, , wwwDownloadcommunication-to-industry guidelineemergency-use section-21 unregistered-products
SAHPGL-MD-06Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs23/03/20233pdfDownloadguidelinemedical-devices
SAHPGL-MD-05Guideline on Medical Device Quality Manual14/03/20234pdfDownloadguidelinemedical-devices
SAHPGL-MD-04 Guideline for Classification of Medical Devices and IVDs25/03/20233pdfDownloadguidelinemedical-devices
8.04Recalls Vigilance Medical Devices IVDs14/11/20193pdfDownloadguidelinemedical-devices
7.06CMs Specified Substances12/01/20223pdfDownloadguidelinecomplementary-medicines
7.05Complementary Medicines Registration Application ZA-CTD-Quality25/06/20202pdfDownloadguidelinecomplementary-medicines
7.04Complementary Medicines – Health Supplements Safety and Efficacy09/03/20224pdfDownloadguidelinecomplementary-medicines
7.03Complementary Medicines – Use of the ZA-CTD format in the preparation of registration applications25/06/20203pdfDownloadguidelinecomplementary-medicines
7.02Roadmap for CMs08/12/20212pdfDownloadguidelinecomplementary-medicines
5.08Reliance Guideline16/03/20223Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-INSP-02Guideline for Good Manufacturing Practice18/09/20228, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing
SAHPGL-PEM-01Availability of medicines for use in a Public Health Emergency (PHE)21/08/20233, , , pdfDownloadguidelineemergency-use general-ectd-human-medicines-guidelines section-21 unregistered-products
SAHPGL-PEM-03Guideline for the API Master File (APIMF) Procedure23/11/20223, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
2.58Submission in eSubmission format18/07/20191Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.23Guideline for submission in eCTD format18/07/20193Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHGPL-HPA-03eCTD Validation Criteria16/11/20224, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa
SAHPGL-CEM-02Guideline for Professional Information for Human Medicines (Categories A and D)07/09/20225, , pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
SAHPGL-CEM-03Guideline for Patient Information Leaflet for Human Medicines (Categories A D)12/10/20227, , pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
SAHPGL-CEM-01Clinical guideline24/08/20223, pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines
SAHPGL-HPA-06Variations Addendum For Human And Veterinary Medicines14/09/20226, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa veterinary-medicines
SAHPGL-PEM-02Quality and Bioequivalence guideline23/05/20238pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-07General information guideline17/04/202311, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa
Industry Communication on Interim Measures Pending Update of Variation Addendum, 10/09/20201pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-BIO-05Biological Medicines Amendment guideline22/09/20225pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-04Biological medicines stability Guideline18/08/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-03Guideline for Pre-Registration Consultation Meeting13/09/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-04Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists04/05/20223pdfDownloadguidelinenames-and-scheduling
SAHPGL-CEM-NS-02Guideline to the scheduling of substances and medicines11/05/20223pdfDownloadguidelinenames-and-scheduling
2.30Biosimilar Medicines Guidance22/08/20143Downloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-03Guideline for proprietary names for medicines10/05/20227pdfDownloadguidelinenames-and-scheduling
7.01Complementary Medicines – Discipline Specific Safety and efficacy25/06/20203pdfDownloadguidelinecomplementary-medicines
8.02Medical Device IVD Essential Principles14/11/20192Downloadguidelinemedical-devices