Guidelines

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Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
8.02Medical Device IVD Essential Principles

2019 Nov

2Downloadguidelinemedical-devices
7.01Complementary Medicines – Discipline Specific Safety and efficacy

2020 Jan

3pdfDownloadguidelinecomplementary-medicines
SAHPGL-CEM-NS-03Guideline for proprietary names for medicines

2022 May

7pdfDownloadguidelinenames-and-scheduling
2.30Biosimilar Medicines Guidance

2014 Aug

3Downloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-02Guideline to the scheduling of substances and medicines

2022 May

3pdfDownloadguidelinenames-and-scheduling
SAHPGL-CEM-NS-04Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists

2022 May

3pdfDownloadguidelinenames-and-scheduling
SAHPGL-PEM-BIO-03Guideline for Pre-Registration Consultation Meeting

2022 Sep

2pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-04Biological medicines stability Guideline

2022 Aug

2pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-05Biological Medicines Amendment guideline

2022 Sep

5pdfDownloadguidelinebiological-medicines-evaluation-and-research
Industry Communication on Interim Measures Pending Update of Variation Addendum,

2020 Sep

1pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
2.01General information guideline

2019 Jul

10Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.02Quality and Bioequivalence

2019 Jul

7Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-06Variations Addendum For Human And Veterinary Medicines

2022 Sep

6, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines veterinary-medicines
SAHPGL-CEM-01Clinical guideline

2022 Aug

3, pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines
SAHPGL-CEM-03Guideline for Patient Information Leaflet for Human Medicines (Categories A D)

2022 oct

7, , pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
SAHPGL-CEM-02Guideline for Professional Information for Human Medicines (Categories A and D)

2022 Sept

5, , pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
2.22eCTD Validation Criteria

2016 Sep

2Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.23Guideline for submission in eCTD format

2019 Jul

3Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.58Submission in eSubmission format

2019 Jul

1Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-03Guideline for the API Master File (APIMF) Procedure

2022 Nov

3, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management pre-reg
SAHPGL-PEM-01Availability of medicines for use in a Public Health Emergency (PHE)

2022 Jun

2, , , pdfDownloadguidelineemergency-use general-ectd-human-medicines-guidelines section-21 unregistered-products
SAHPGL-INSP-02Guideline for Good Manufacturing Practice

2022 Sep

8, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing
5.08Reliance Guideline

2022 Mar

3Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-05BAU Variations Communication,

2022 Sep

4pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
9.127eCTD Implementation roadmap communication

2021 Oct

2Downloadguidelinegeneral-ectd-human-medicines-guidelines
9.128Pilot: BAU new medicine applications for registration

2021 Jul

2Downloadguidelinegeneral-ectd-human-medicines-guidelines
9.129Re-submission of BAU New Medicines Applications from 2018 and 2019

2021 Oct

2Downloadguidelinegeneral-ectd-human-medicines-guidelines
7.02Roadmap for CMs

2021 Dec

2pdfDownloadguidelinecomplementary-medicines
7.03Complementary Medicines – Use of the ZA-CTD format in the preparation of registration applications

2020 Jun

3pdfDownloadguidelinecomplementary-medicines
7.04Complementary Medicines – Health Supplements Safety and Efficacy

2022 Mar

4pdfDownloadguidelinecomplementary-medicines
7.05Complementary Medicines Registration Application ZA-CTD-Quality

2020 Jun

2pdfDownloadguidelinecomplementary-medicines
7.06CMs Specified Substances

2022 Jan

3pdfDownloadguidelinecomplementary-medicines
8.04Recalls Vigilance Medical Devices IVDs

2019 Nov

3pdfDownloadguidelinemedical-devices
8.05CLASSIFICATION of MEDICAL DEVICES and IVDs

2021 Aug

5pdfDownloadguidelinemedical-devices
8.07Medical Device Quality Manual

2019 Nov

2pdfDownloadguidelinemedical-devices
16.03Licence Medical Devices IVDs

2019 Nov

3pdfDownloadguidelinemedical-devices
Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME,

2022 May

2, , wwwDownloadcommunication-to-industry guidelineemergency-use section-21 unregistered-products
SAHPGL-CEM-S21-02Guideline For Section 21 Access To Unregistered Medicines

2022 Aug

4, , pdfDownloadguidelineemergency-use section-21 unregistered-products
SAHPGL-INSP-01Guideline for Post Importation Testing

2022 Sep

5pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-03Guideline for Good Wholesaling Practice for Wholesaler

2022 Sep

5, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-04Guideline for preparation of site master file

2022 Sep

5, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-05Guideline on how to respond to a GMP, GWP, GCP and GVP Inspection report

2022 Sep

2pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-06Guideline for Fee determination and Payment of GxP and Product related Inspection

2022 Sep

2pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-LIC-01Licence to Manufacture, Import or Export

2022 Jun

3pdfDownloadguidelinelicencing
SAHPGL-INSP-RC-02Guideline for the Importation and Exportation of Medicines

2022 Jun

2pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-12Guideline On How To Lodge A Complaint On Medicines And Medical Devices

2022 Nov

4pdfDownloadguidelineregulatory-compliance
SAHPGL-CEM-PV-06Guideline For Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals

2022 Aug

3pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-05Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety

2022 Aug

6pdfDownloadguidelinepharmacovigilance
SA GCP Guidelines

2020 Jun

3Downloadguidelineclinical-trials
SAHPGL-CEM-CT-10Safety Reporting During Clinical Trials

2022 Oct

5pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-03Emergency Procedures for Clinical Trial Sites

2022 Aug

3pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-07Post Clinical Trial Access

2022 Aug

4pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-04Oversight and Monitoring in Clinical Trials

2022 Aug

4pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-08Guideline for Capacity Building and Transformation in Clinical Research in South Africa

2022 Oct

2pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-02Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model

2022 Jul

2pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-05Liability Insurance for Clinical Trials

2022 Aug

3pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-06Procedure for Consultation Meetings with Clinical Trial Applicants

2022 Aug

2pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-01Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events),

2022 Sept

3pdfDownloadcommunication-to-industry guidelineclinical-trials
SAHPGL-CEM-CT-09Guideline for Clinical Trial Investigators,

2022 Oct

3pdfDownloadcommunication-to-industry guidelineclinical-trials
17.05SAHPRA Payment Guideline

2022 Sept

7pdfDownloadguidelinefinance
2.48Veterinary Medicines Exemptions guidelines

2020 Mar

1, Downloadguidelinequality veterinary-medicines
SAHPGL-PEM-VET-02Veterinary Medicines Clinical Guideline

2022 Sept

2, pdfDownloadguidelinequality veterinary-medicines
2.40Multiple submissions of the same application for registration with different proprietary names

2019 May

4Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-BIO-06General guidance document on QSE for Biological Medicines

2022 Aug

2pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-GOV-01Guideline for appeals against Regulatory decisions

2022 Apr

1pdfDownloadguidelinequality-management-system
SAHPGL-CEM-PV-01Pharmacovigilance Inspections for Human Medicinal Products

2022 May

1pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-02Pharmacovigilance systems

2022 May

1pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-NS-01Application for rescheduling of a substance or medicine

2022 May

1pdfDownloadguidelinenames-and-scheduling
SAHPGL-PEM-BIO-01Guideline for Lot Release of Human Vaccines

2022 Sep

3pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-PV-04POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA

2022 Jun

9pdfDownloadguidelinepharmacovigilance
SAHPGL-INSP-RC-05Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts

2022 Jun

3pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-06 Guideline to Fee Determination and Payments of Permits and Related Authorisations

2022 Jun

1pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-07Guidelines for Advertisement of Medicines and Health Products

2022 Jun

2pdfDownloadguidelineregulatory-compliance
SAHPGL-INS-RC-11Guideline for Release of Import Health Products at Ports of Entry

2022 Jun

2pdfDownloadguidelineregulatory-compliance
SAHPGL-INS-RC-1Guidelines for Market Surveillance Of Medicines

2022 Jun

2pdfDownloadguidelineregulatory-compliance
SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process

2022 Jun

1, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines veterinary-medicines
SAHPGL-LIC-02Guideline on How to Apply for A Licence to Act as A Wholesaler

2022 Jun

2pdfDownloadguidelinelicencing
SAHPGL-LIC-03Guideline on How to Amend a Current Licence

2022 Jun

1pdfDownloadguidelinelicencing
Guideline on completion of the veterinary medicines clinical trial application form

2019 Sep

1, , Downloadguidelineclinical-trials quality veterinary-medicines
SAHPGL-PEM-VET-01Guideline on application for use of unregistered veterinary medicines

2022 Aug

3, , , pdfDownloadguidelineemergency-use section-21 unregistered-products veterinary-medicines
SAHPGL-INSP-RC-13Guideline For Cultivation Of Cannabis

2022 Nov

3, , pdfDownloadguidelinecannabis licencing regulatory-compliance
SAHPGL-RDN-RN-05Guideline On Afterloader Source Exchange Forms (RNXM)

2022 Jul

1, pdfDownloadguidelineradiation-control radionuclides
2.21South African Specification for eCTD Regional Module1

2019 May

3Downloadguidelinegeneral-ectd-human-medicines-guidelines
Medical Examinations For Radiation Workers

2009 Jul

2, Downloadguidelineradiation-control radionuclides
SAHGPL-RDN-XR-19Guideline for Management of Pregnant Radiographers and Other Staff Members

2022 Sept

1, , pdfDownloadguidelineradiation-control radionuclides x-rays
Internal rules – Minimum requirements

2009 Jul

2, Downloadguidelineradiation-control radionuclides
Leak tests

2005 Sep

2, Downloadguidelineradiation-control radionuclides
Licensing Requirements For New Nuclear Medicine Practices

2014 Sep

2, Downloadguidelineradiation-control radionuclides
RN-INF-RPO-001RPO Competence and Training – Interim Position Document

2013 Aug

2, Downloadguidelineradiation-control radionuclides
Guidelines Regarding Organisational Requirements For Authority Holders And Their Appointed Radiation Protection Officers In Respect Of Group Iv Hazardous Substances

2009 Jul

2, Downloadguidelineradiation-control radionuclides
Code of Practice – Safe use of soil moisture and density gauges

2019 Jul

5, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-XR-15Guideline for Ionising Radiation Dose Limits and Annual Limits on Intake of Radioactive Material

2022 Aug

1, , pdfDownloadguidelineradiation-control radionuclides x-rays
FIREProtective measures to take in the event of an accident involving radioactivity

2001 Feb

2, Downloadguidelineradiation-control radionuclides
GAUGECode of Practice for the safe use of industrial gauges containing radioactive sources

2019 May

2, Downloadguidelineradiation-control radionuclides
IRCP91-2Industrial radiography (gamma radiography)

2019 May

2, Downloadguidelineradiation-control radionuclides
RN-GLN-EPR-001Guidelines for Reporting National Radiation Occurrence

2018 Jul

2, Downloadguidelineradiation-control radionuclides
RN-GLN-MED-131Iodine-131 therapy

2009 Jul

1, Downloadguidelineradiation-control radionuclides
RN-REQ-SRC-001Label sources & containers

2014 Jul

1, Downloadguidelineradiation-control radionuclides
TRUG91-1Safe transport of radioactive material

2005 May

2, Downloadguidelineradiation-control radionuclides
UNSEALSafe use of unsealed radioactive nuclides

2001 Feb

2, Downloadguidelineradiation-control radionuclides
Wscp91-1Management and disposal of non-nuclear radioactive waste

2005 May

2, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-XR-21Guideline for Patient Dose Measurements in Diagnostic Radiology

2022 Sept

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-22Guideline for Protective Clothing

2022 Sept

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-20Guideline for Use of Radiographic Grid Ratio

2022 Sept

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-10Guideline For Radiation Monitoring Requirements And Radiation Occurrences

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-18Guidelines on Requests for Medical X-Ray Examinations

2022 Sept

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-14Guideline of Test Procedures for Film Processing and Intensifying Screens

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-01Guideline for QC in Medical Diagnostic X-Ray Imaging Systems

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-13Guideline for QC in Dental Diagnostic X-Ray Imaging Systems

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-08Guideline for Personal Monitoring Med and Vet Use of Diagnostic X-Ray Equipment

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-05General Guideline For Cabinet And Conveyer Belt X-ray

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-11General Guidelines with Regards to the Design of X-Ray Rooms

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-02Guideline For Code Of Practice For Users Of Medical Xray Equipment

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-06Guideline For Reducing Radiation Risk From Computer Tomography For Pediatric And Small Adult Patients

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-04Guideline for Minimum Requirements For Fixed Diagnostic X-Ray Installations

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-12Guideline for Monitoring of Radiation workers in a Theatre

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-07Guideline for Bone Densitometer – Operators

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-16Guideline for Code of Practise for Industrial Radiography X-Ray

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-09Guideline For Code Of Practice For Users Of Non – Medical X-RAY Equipment – Forensic

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-23Guideline Radiologist Available by Remote Digital Connection

2022 Sept

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-03Guideline for Dental Radiography

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-17Guideline for Disposal of X-Ray Units and Tubes Containing Beryllium

2022 Aug

1, pdfDownloadguidelineradiation-control x-rays
SAHPGL-CEM-PV-03Risk Management Plans for Medicines for Human Use

2022 Sep

1pdfDownloadguidelinepharmacovigilance
8.06Guideline For Access To And Control Of Medical Devices And IVDs

2017 Apr

1Downloadguidelinemedical-devices
8.01General Information Medical Devices And IVDs

2014 Aug

1Downloadguidelinemedical-devices