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Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
No. 40480Regulations Relating to Medical Devices and In-Vitro Diagnostic Medical Devices (IVDs)09/12/2016, pdfDownloadregulationcorporate medical-devices
DHCPLPharmacare and Multiple Collaborators DHCPL: Valaciclovir/Aciclovir – Containing Medicines – Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)19/01/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
SAHPGL-RDN-XR-25Guidelines For Users of Electronic Therapeutic Devices Emitting Ionizing Radiation13/12/20231, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-24Guideline for Import Applications of Electronic Devices Emitting Ionizing Radiation13/12/20231, pdfDownloadguidelineradiation-control x-rays
DHCPLValaciclovir-Aciclovir-Containing Medicines Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)10/01/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
CT03-2023COVID-19 Clinical Trials – Two-Weekly Progress Reports02/01/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
GLF-RC-INSP-05CPost recall information/FINAL REPORT to SAHPRA30/01/20242pdfDownloadformregulatory-compliance
GLF-RC-INSP-05BRecall Letter to customers, 30/01/20242pdfDownloadform templatesregulatory-compliance
GLF-RC-INSP-05ARecall Information30/01/20242pdfDownloadformregulatory-compliance
Clinical Trial Applications Electronic System13/12/20231, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
Medi-Guardian Newsletter November 202330/11/20231wwwDownloadnewsletterpharmacovigilance
DHCPLPotential Missing Professional Information (PI) and Patient Information Leaflet (PIL) in Folding Boxes of Pertjeta® 420 mg/14 mL infusion (pertuzumab)30/11/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLPotential Missing Professional Information (PI) and Patient Information Leaflet (PIL) in Folding Boxes of Hemlibra® 60 mg/0,4 mL solution for injection (emicizumab):30/11/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
Cannabis Pre Licence Application Status Letter19/02/20211pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices
DHCPLThe risk of acute tubulointerstitial nephritis (TIN) associated with proton pump inhibitors (PPIs)30/10/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
ALL VACCINES including COVID-19 : Case Reporting Form (CRF) for Adverse Events Following Immunisation (AEFI)29/01/20211pdfDownloadformpharmacovigilance
COVID-19: Case Reporting Form (CRF) for suspected Adverse Events of Special Interest (AESI)28/01/20211pdfDownloadformpharmacovigilance
ALL VACCINES including COVID-19: Case Investigation Form (CIF) Adverse Events Following Immunisation (AEFI) AND Adverse Events of Special Interest (AESI)28/01/20211pdfDownloadformpharmacovigilance
Clinical Trials Committee and Submission Dates for 2024, 12/10/20231, pdfDownloadcommunication-to-industry guidelineclinical-evaluations-management clinical-trials
Vaccine Safety Surveillance (VSS) In South Africa, 09/10/20231wwwDownloadguide manualpharmacovigilance
DHCPLGolimumab SIMPONI® 50 mg: Important Changes to the Instructions For Use (IFU) for the SmartJect® Autoinjector/Pre-filled Pen04/10/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
Medicines Online Directory Toolkit, , , 03/10/20231, wwwDownloadguide guideline presentations toolkitcorporate general-ectd-human-medicines-guidelines
MD038SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/74602/10/20231, pdfDownloadcommunication-to-industrymedical-devices radiation-control
Annual Report (2022/2023)13/09/20231pdfDownloadannual-reportcorporate
DHCPLSection 36 approval – KLACID XL04/09/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
A Primer for Clinical Assessors within African Regulatory Agencies11/09/20231pdfDownloadreportcorporate
VMRF1Veterinary Medicines Registration form16/09/20221docxDownloadformveterinary-medicines
Process Flow of Importation of Medical Products Published17/07/20231, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices regulatory-compliance
DHCPLSection 36 Approval – MeasBio Vaccine17/07/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
HPA13Digital Variations Portal (DVP) User Changes11/07/20231pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
GLF-HPA-04AECTD Validation And Technical Screening For Renewals22/08/20233docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-VET-04General Information Guideline for Registration of Veterinary Medicines27/06/20234pdfDownloadguidelineveterinary-medicines
Annual retention fee payment notification for the Financial year ending 31 March 202408/06/20231pdfDownloadcommunication-to-industryfinance
B-BBEE Policy for Issuance of Licences as per Section 22c of the Medicines Act23/06/20231pdfDownloadcommunication-to-industrylegal
DHCPLBupropion Containing Medicines – Risk Of Brugada Syndrome (Adcock, Tev, Acino, and SunPharma)22/05/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLBupropion containing medicines – Risk of of Brugada Syndrome (GSK)08/06/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
HPA-08FAQs on Medicine Registration Renewals22/08/20235, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Communication to industry – SAHPRA Statement on Regulation of Category D Medicines02/06/20231pdfDownloadcommunication-to-industrycomplementary-medicines
Communication to Industry – Summary of Medicine Safety Regulatory Decisions02/06/20231pdfDownloadcommunication-to-industrypharmacovigilance
HPA12Communication to Industry – Health Products Register Notification31/05/20231pdfDownloadcommunication-to-industryhpa
PEM03-2022/23Implementation of the QOS and QIS23/05/20231, , pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
GLF-PEM-02ELetter of Access for Reliance26/05/20231, , docxDownloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
DHCPLSynthroid – Range of tablets: Typing error in Professional Information (PI) and Patient Information Leaflet (PIL)21/05/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
2.24Guidance For The Submission Of The South African CTD-eCTD – General & Module15/05/20196Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPRA Annual Performance Plan 2023– 202403/05/20231pdfDownloadplanning-documentcorporate
GLF-PEM-02DTemplate for Module 2.3_Quality Overall Summary (QOS)03/05/20231, docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
GLF-PEM-02CTemplate for Module 2.3_Quality Information Summary (QIS)03/05/20231, docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
Summary of Medicine Safety Regulatory Decisions13/04/20231pdfDownloadcommunication-to-industrypharmacovigilance
DHCPLGabapentinoids – Risk of Serious Breathing Difficulty18/04/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
No. 48358Medicines and Related Substance Act_1965_Schedules24/03/20233261pdfDownloadgovernment-gazettecorporate
OF-PEM-PRE-01QQuality And Bioequivalence Verified Review Template13/04/20231, , docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
DHCPLDHCPL_Section 36 approval – Measbio vaccine12/04/20231wwwDownloadcommunication-to-health-care-professionalspharmacovigilance
SAHPGL-PEM-04International Metric System (SI)23/03/20234pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
RN528Application For Cancellation Of Authority To Handle Radioactive Material10/12/20091, docxDownloadformradiation-control radionuclides
HPA-11Communication on Hard Copy Registration Certificates17/02/20231, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
SBVETMR-1 Application for a licence to use an MRI device (veterinary)14/03/20181, docDownloadformnirmed radiation-control
SBMR-1Application for a licence to use an MRI device (medical)14/03/20181, docDownloadformnirmed radiation-control
SBLN-1Application for a licence to use a non-medical laser21/03/20181, docDownloadformnirmed radiation-control
SBLM-1Application for a licence to use a medical laser20/03/20181, docDownloadformnirmed radiation-control
GLF-RDN-NM-01AApplication for Licence to Import a New Listed Electromagnetic Product1, docxDownloadformnirmed radiation-control
GLF-RDN-NM-01BApplication for a Licence to Import Listed Electronic Product (Non Medical)08/03/20231, docxDownloadformnirmed radiation-control
GLF-RDN-NM-01CApplication for a Licence to Manufacture a Listed Electromagnetic Product (Non Medical) in South Africa08/03/20231, docxDownloadformnirmed radiation-control
GLF-RDN-NM-01DApplication for a Licence to Import for a Fully Refurbished Electronic Product08/03/20231, docxDownloadformnirmed radiation-control
Verification of Fees and Bank details22/02/20231pdfDownloadcommunication-to-industryfinance
GLF-RDN-XR-25DDetails of transaction for a therapeutic particle accelerator16/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24GApplication for a licence to manufacture a listed electromedical device SA09/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24FApplication for a licence to import a listed electronic product15/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24EApplication for a licence to import a fully refurbished listed electromedical device16/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24DApplication for a licence to manufacture or fully refurbish a listed electromedical device SA16/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24CApplication for a licence to import a new listed electronic product16/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24BApplication for a licence to conduct clinical trials on locally manufactured listed electromedical product23/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24AApplication for a licence to import a listed electromedical product to conduct clinical trials09/02/20231, docxDownloadformradiation-control x-rays
SAHPGL-MD-07Guideline on Questions and Answers Licensing of Medical Device Establishments, 17/11/20233pdfDownloadfaq guidelinemedical-devices
GLF-RDN-XR-16A (Old RC013)Application To Register As An Industrial Radiographer (X-ray Radiography)12/04/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-03BApplication For Exemption From Personal Monitoring: Dental Radiography12/04/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02DApplication Re-activate Licence For Stored Cancelled Electronic Product18/08/20221, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02CResponsible Person18/08/20221, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02BApplication For A Licence To Use An X-ray Device13/08/20221, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02AApplication Disposal Of A Licensed Electronic Product And Or New/ Modified Premises18/08/20221, docxDownloadformradiation-control x-rays
GLF-RDN-XR-25AApplication for a licence to use a therapeutic device in terms of article 4(1)(b) AND 4(1)(c)08/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-25BChange appointment of responsible person or medical08/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-25CDisposal modification of a therapeutic device or particle accelerator and or new modified premises23/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-03AApplication for a Licence to Use as Per Condition 03 of Your Licence to Import or Manufacture15/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02GApplication form for a Licence to Install and Use an X-Ray Device and Related Components16/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02EApplication Form for Appointment, Termination of a Medical Physicist for Interventional Radiology15/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-10ANotification of Radiation Occurrence08/02/20231, docxDownloadformradiation-control x-rays
SAHPGL-CEM-PRE-01Guideline on Co-packaging of Medicines15/02/20231, , pdfDownloadguidelinecem-pre-reg clinical-evaluations-management general-ectd-human-medicines-guidelines
HPA-10Communication to Industry – Pilot Application Process through the SAHPRA Service Desk01/02/20231, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Communication to Industry – Importing and operating unlicensed dental X-ray equipment16/02/20231pdfDownloadcommunication-to-industryradiation-control
HPA01-2022Medicines Registration Renewals Implementation Framework22/08/20236pdfDownloadcommunication-to-industrygeneral-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
OF-QA-09AGuidelines Comments Form04/01/20232docDownloadformquality-management-system
HPA09Pre-registration veterinary medicines tracker guide08/12/20221, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines veterinary-medicines
Certification Variation Screening – Type II Proprietary Name Change Applications and TOAs14/12/20222pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
RN900Incident Notification Form07/12/20211, Downloadformradiation-control radionuclides
RN800Notice of Complaint07/12/20211, Downloadformradiation-control radionuclides
RN855App_Maintenance work on apparatus with sealed RS07/12/20211, Downloadformradiation-control radionuclides
RN789App_ Convey only1, Downloadformradiation-control radionuclides
RN788Temp Use Loan07/12/20211, Downloadformradiation-control radionuclides
RN787AList of premises & rooms08/12/20211, Downloadformradiation-control radionuclides
RN787App_Renewal or new source authority07/12/20211, docxDownloadformradiation-control radionuclides
RN786AApp_RPA Radiation Protection Adviser07/12/20211, Downloadformradiation-control radionuclides
RN786App_Change of physicists07/12/20211, Downloadformradiation-control radionuclides
RN785App_Change of RPO07/12/20211, Downloadformradiation-control radionuclides
RN782aConfirmation of export07/12/20211, Downloadformradiation-control radionuclides
GLF-RDN-RN-17A (Previously RN782)Export application07/12/20221, docxDownloadformradiation-control radionuclides
RN781aConfirmation of import07/12/20211, Downloadformradiation-control radionuclides
GLF-RDN-RN-16A (Previously RN781)Import application07/12/20221, docxDownloadformradiation-control radionuclides
RN780Log for sealed gamma radiography sources07/12/20211, Downloadformradiation-control radionuclides
RN778App_Register industrial radiographer13/12/20211, Downloadformradiation-control radionuclides
RN621Application to release equipment from storage at NLM (NECSA)13/12/20211, Downloadformradiation-control radionuclides
RN608Particulars of sealed radioactive sources08/12/20211, Downloadformradiation-control radionuclides
RN607Medical report08/12/20211, docxDownloadformradiation-control radionuclides
RN527App_Change details15/12/20211, docxDownloadformradiation-control radionuclides
RN526App_Dispose of (sell) radionuclides09/12/20211, docxDownloadformradiation-control radionuclides
RN525iApp_Discard sealed sources09/12/20211, docxDownloadformradiation-control radionuclides
RN525App_Discard sealed sources09/12/20211, docxDownloadformradiation-control radionuclides
RN524App_Solid RA waste09/12/20211, docxDownloadformradiation-control radionuclides
RN523App_Liquid RA waste10/12/20211, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-15A (Previously RN002)Monthly Report – Unsealed Sources07/12/20221, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-14A (Previously RN001)Monthly Report – Sealed Sources07/12/20221, docxDownloadformradiation-control radionuclides
Expression of Interest-WHO Pre-Qualification Collaborative Registration Procedure17/11/20221pdfDownloadcommunication-to-industrygeneral-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
Clinical Trials Committee And Submission Dates For 202314/10/20221, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
Common deficiencies found in API section of Non-Sterile Generic Products submitted for registration to SAHPRA08/12/20211pdfDownloadpublished-papers
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to SAHPRA16/06/20221pdfDownloadpublished-papers
Common deficiencies found in generic FPP applications submitted for registration to SAHPRA16/12/20211pdfDownloadpublished-papers
South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access15/07/20211pdfDownloadpublished-papers
DHCPLTopical corticosteroids – DHCPL – Risk of withdrawal reactions19/10/20221pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
GLF-PEM-02ASubmission Form14/10/20221docxDownloadformgeneral-ectd-human-medicines-guidelines
GLF-PEM-02BTemplate of Standardised Content of Letter of Access14/10/20221docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
HPA07Certification Variation Screening – Type II Proprietary name change applications and TOA’s20/10/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa)13/10/20221docxDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Annual Report (2021/2022)15/09/20221wwwDownloadannual-reportcorporate
SAHPP-QA-01Quality Policy Statement09/02/20211pdfDownloadpoliciesquality-management-system
No. 40869Medicines and Related Substances Act Schedules26/05/2017pdfDownloadgovernment-gazettecorporate
OF-PEM-VET-04ABioequivalence Trial Information for Veterinary Medicines16/09/20221docxDownloadformveterinary-medicines
GLF-PEM-VET-04AResidue Overall Summary (ROS)15/09/20221docxDownloadtemplatesveterinary-medicines
OF-PEM-VET-04BVeterinary Medicines Biowaiver Application Form for Parenterals07/09/20221docxDownloadformveterinary-medicines
Over-arching: Good Review Practice Guide, 24/06/20221, pdfDownloadcommunication-to-industry guidecorporate general-ectd-human-medicines-guidelines
Extension on commentary period for Borderline Products Guideline15/09/20221, pdfDownloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines
GLF-BAU-HPA-07AMedicines Application Form Module 1.2.1, 18/05/20237docxDownloadapplication-forms formgeneral-ectd-human-medicines-guidelines
SAHPGL-RDN-XR-17Guideline for Disposal of X-Ray Units and Tubes Containing Beryllium17/08/20221, pdfDownloadguidelineradiation-control x-rays
Owner Consent Form, 18/07/20192Downloadapplication-forms formveterinary-medicines
Veterinary Clinical Trial Application Template18/12/20192, Downloadtemplatesclinical-trials veterinary-medicines
OF-PEM-VET-01EApplication form for unregistered veterinary medicines (Section 21), 19/08/20222, , docxDownloadapplication-forms formsection-21 unregistered-products veterinary-medicines
OF-PEM-VET-01DProgress Report Form After Use Of An Unregistered Product, 05/08/20221, , , docxDownloadform report-formsemergency-use section-21 unregistered-products veterinary-medicines
MD037Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators22/07/20221pdfDownloadcommunication-to-industrymedical-devices
Missing Applications – Call to Industry18/08/20221, , pdfDownloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines information-technology
GLF-CEM-PV-06AAdverse Drug Reactions and Quality Problem Reporting Form22/11/20233pdfDownloadformpharmacovigilance
DHCPLAnagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation17/08/20221pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCefepime hydrochloride – Risk of serious adverse reactions17/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLValproate containing medicines – High risk of congenital abnormalities and development disorders03/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLClozapine – Induced gastrointestinal hypomotility17/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLHydrochlorothiazide – Risk of non-menoloma skin cancer10/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLLamotrigine – Risk of Hemophagocytic Lymphohistiocytosis17/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLHyoscine Butylbromide – Risk of adverse effects in patients with underlying cardiac disease03/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLAmphotericin B – Risk of Medication Error10/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLEPOETIN ALFA – New warnings on severe cutaneous adverse reaction11/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLGadolinium-Based Contrast Agents – Deposition in the brain11/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDolutegravir – Risk of neural tube defects09/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers13/06/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers13/06/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers17/07/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers16/08/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers – 1 August 201916/08/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Pradaxa16/08/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Xarelto15/08/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Eliquis13/09/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDHCPL for ACE-inhibitor/Angiotensin receptor blocker containing medicines11/10/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLFluoroquinolones: risk of mitral and aortic regurgitation associated with the use of oral and injectable fluoroquinolones10/06/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSandoz and Novartis: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy12/06/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLOndansetron: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy12/06/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLTyrosine kinase inhibitors18/06/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLFluoropyrimidine containing medicines and related substances: Increased drug exposure and toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency22/10/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of dopamine dysregulation syndrome (DDS) associated with the use of dopaminergic medicines used for the treatment of Parkinson’s disease (PD).25/11/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLTecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) and Immune-related myositis19/11/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDopaminergic medicines used in the treatment of parkinson’s disease: Risk of Dopamine dysregulation syndrome22/10/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDiphenhydramine-containing Medicines20/11/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLEltroxin New Formulation (25 Mcg, 50 Mcg, 75 Mcg, 100 And 200 Mcg Tablets: Increased Adverse Events Reports And Requirement For Patient Therapeutic Monitoring By Healthcare Professionals.09/12/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased Risk Of Subclinical Acute Interstitial Nephritis Associated With The Use Of Proton Pump Inhibitors (Ppis) Leading To Acute Kidney Injury And/or Chronic Renal Failure11/02/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk Of Drug Induced Liver Injury Associated With The Use Of Metamizole-containing Medicines18/03/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals07/04/20211wwwDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCOVID-19 Vaccine Janssen: Risk of Thrombosis in combination with Thrombocytopenia18/11/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDopaminergic Medicines used in the treatment of Parkinson’s Disease: Risk of Dopamine Dysregulation Syndrome13/05/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
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DHCPLCOVID-19 Vaccine Janssen23/07/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines12/08/20211wwwDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCOMIRNATY® (COVID-19 mRNA Vaccine) -Warning regarding rare cases of Myocarditis and Pericarditis13/08/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
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DHCPLTopical Corticosteroid – Risk of Withdrawal Reactions – Aspen16/08/20222pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
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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
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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
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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
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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
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Internal rules – Minimum requirements23/07/20092, Downloadguidelineradiation-control radionuclides
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Medical Examinations For Radiation Workers16/07/20092, Downloadguidelineradiation-control radionuclides
2.21South African Specification for eCTD Regional Module130/05/20193Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPRA Digital Transformation – Deployment of a Stakeholder portal17/08/20221, pdfDownloadcommunication-to-industrycorporate information-technology
Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting18/08/20221pdfDownloadcommunication-to-industrypharmacovigilance
NSTF-South 32 Awards 2021-202214/07/20221pdfDownloadnewslettercorporate
No. 44026Regulations Regarding Fees Payable In Terms Of The Provisions Of The Medicines And Related Substances Act, 1965 (Act No. 101 Of 1965)09/12/2020666pdfDownloadgovernment-gazettecorporate
No. 43346Exclusion Of Medicines, Medical Devices And (IVDs) Donated To The State22/05/2020659pdfDownloadgovernment-gazettecorporate
No. 41064General Regulations – Medicines And Related Substances Act, 1965 (25 August 2017), 25/08/2017859pdfDownloadgovernment-gazette regulationcorporate
No. 43347Amendment To Schedules – CBD-containing Products 202015/05/2020659pdfDownloadgovernment-gazettecorporate
No. 43484Published Gazette – Alcohol based hand sanitiser 202025/06/2020721pdfDownloadgovernment-gazettecorporate
No. 45673Published Gazette – Extension Notice (SECTION 18 OF ACT 101)16/12/2021678pdfDownloadgovernment-gazettecorporate
No. 25899Broad-based Black Economic Empowerment Act 200314/01/2004463pdfDownloadactcorporate
No. 20853Promotion Of Administrative Justice Act 3 Of 200017/02/2000316pdfDownloadactcorporate
No. 20852Promotion Of Access To Information Act 2 Of 200017/02/2000416pdfDownloadactcorporate
No. 18491Basic Conditions Of Employment Act, 75 Of 199719/12/1997390pdfDownloadactcorporate
No. 866Customs And Excise Act, 1964 (Act No. 91 Of 1964)09/07/1964XIIIpdfDownloadactcorporate
No. 4442Pharmacy Act, 1974 (Act No. 53 Of 1974)18/10/1974112pdfDownloadactcorporate
No. 8883Nursing Act, 1978 (Act No. 50 Of 1978)11/05/2006491pdfDownloadactcorporate
Health Professions Act, 1974 (Act No. 56 Of 1974)15/02/2007pdfDownloadactcorporate
No. 19519Environmental Management Act: Waste Management Act, 1998 (Act No. 107 Of 1998)04/11/1998401pdfDownloadactcorporate
No. 3530Foodstuffs, Cosmetics And Disinfectants Act, 1972 (Act No. 54 Of 1972) As Amended22/06/197284pdfDownloadactcorporate
VigiGuardian Newsletter July 202214/07/20221wwwDownloadnewsletterpharmacovigilance
Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process, 24/10/20191pdfDownloadcommunication-to-industry expression-of-interestgeneral-ectd-human-medicines-guidelines
SAHPRA Strategic Plan 2020 and 2021 – 2024 and 202529/06/20221pdfDownloadplanning-documentcorporate
Strategic Framework23/07/20201pdfDownloadplanning-documentcorporate
SAHPRA Annual Performance Plan 2020 – 202125/06/20201pdfDownloadplanning-documentcorporate
SAHPRA Annual Performance Plan 2021 – 202221/10/20211pdfDownloadplanning-documentcorporate
SAHPRA Annual Performance Plan 2022 – 202330/06/20221pdfDownloadplanning-documentcorporate
The Innovation In Regulatory Sciences Capacity Development In Africa Meeting24/06/20201pdfDownloadreportcorporate
SAHPGL-RDN-RN-05Guideline On Afterloader Source Exchange Forms (RNXM)20/07/20221, pdfDownloadguidelineradiation-control radionuclides
No. 14143Drugs And Drug Trafficking Act, 1992 (Act No. 140 Of 1992)23/07/1992329pdfDownloadactcorporate
No. 8051Veterinary And Para-veterinary Professions Act, 1982 (Act No. 19 Of 1982)10/03/1982201pdfDownloadactcorporate
No. 9152Animal Diseases Act, 1984 (Act No. 35 Of 1984)18/04/1984226pdfDownloadactcorporate
No. 3751Fertilisers, farm feeds, agricultural remedies and stock remedies act, 1947 (act no. 36 of 1947)08/01/1947CXLVIIpdfDownloadactcorporate
No. 26595National Health Act, 2003 (Act No. 61 Of 2003)23/07/2004469pdfDownloadactcorporate
No. 3834Hazardous Substances Act (Act No. 15 Of 1973)11/05/201794pdfDownloadactcorporate
41064General Regulations17/08/2017pdfDownloadregulationcorporate
40869Medicines And Related Substances Act, 1965 (Act no. 101 Of 1965) as amended10/05/2017pdfDownloadactcorporate
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
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MD036COVID-19 Test Kits Batch Verification16/06/20221wwwDownloadcommunication-to-industrymedical-devices
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SAHPGL-LIC-03Guideline on How to Amend a Current Licence22/06/20221pdfDownloadguidelinelicencing
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SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process16/08/20234, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa veterinary-medicines
Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals16/06/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
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 Alerts30/01/20243pdfDownloadguidelineregulatory-compliance
Summary of Medicines Safety Regulatory Decisions23/06/20221pdfDownloadcommunication-to-industrypharmacovigilance
SAHPGL-CEM-PV-04Post-marketing Reporting Of Adverse Drug Reactions To Human Medicines In South Africa08/06/20229pdfDownloadguidelinepharmacovigilance
Communication on Medicines Registration Renewals Implementation Framework24/11/20222, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines
Retention Fee Notification – 9 June 202224/06/20221, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices
OF-GOV-01ARequest for access to record of held by SAHPRA (PAIA form)08/04/20211docxDownloadformcorporate
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Radiation Control24/10/20191pdfDownloadpresentationsradiation-control
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PRESENTATION TO THE NCC- MINISTER OF HEALTH- 19 MAY 202021/05/20201pdfDownloadpresentationscorporate
Update on COVID-19 Diagnostic tests18/06/20201pdfDownloadpresentationsmedical-devices
COVID-19 vaccines Regulatory Status Update17/06/20211pdfDownloadpresentationsbiological-medicines-evaluation-and-research
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Communication to Industry – Applications for GMP and CPP Certificates30/06/20221pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices
GLF-PEM-BIO-01AApplication Form for Lot Release of Human Vaccine, 08/06/20233pdfDownloadapplication-forms formbiological-medicines-evaluation-and-research
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SAHPGL-PEM-BIO-06General guidance document on QSE for Biological Medicines24/08/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
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Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines24/03/20221, pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research inspectorate-and-good-manufacturing-practices
7.04Communication to industry – 7.04 Health Supplements Safety and Efficacy17/03/20221pdfDownloadcommunication-to-industrycomplementary-medicines
Requests: Existing Category D (Complementary Medicines) Registration Applications (07 October 2021)17/02/20221pdfDownloadcommunication-to-industrycomplementary-medicines
HPA03Priority Review Requests Communication11/12/20233pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
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MD031Medical Device Establishment Licence Renewal Process22/09/20222pdfDownloadcommunication-to-industrymedical-devices
MD030Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication02/02/20221pdfDownloadcommunication-to-industrymedical-devices
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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
GLF-CEM-CT-01HSafety Reporting during Clinical Trial Form, 13/10/20224docxDownloadapplication-forms formclinical-trials
6.36Investigators workload Form, 22/04/20203Downloadapplication-forms formclinical-trials
GLF-CEM-CT-01GSix monthly progress report form, 22/09/20225docxDownloadform report-formsclinical-trials
GLF-CEM-CT-01D (CTF3)Application for Additional Investigator(s) or Change of Investigator(s)/Sites and Application for Additional Sites, 15/09/20224docxDownloadapplication-forms formclinical-trials
GLF-CEM-CT-01C (CTF2)Application for a Protocol Amendment to an Approved Trial, 15/09/20224docxDownloadapplication-forms formclinical-trials
GLF-CEM-CT-01F2-Weekly Abridged Public Health Emergency Interim Progress Report Form for Clinical Trials, 07/09/20222docxDownloadform report-formsclinical-trials
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Application for a Permit to Export Narcotic and/or Psychotropic Substances in terms of the Medicines and Related Substances Act, 1965 (Act 101 Of 1965), The Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances, 1971: Regulation 20(4) and 20(7)(A), 15/04/20201Downloadapplication-forms formregulatory-compliance
Application for a Permit to Import Drugs and/or Psycotropic Substances in terms of the Medicines and Related Substances Act, 1965 (Act 101 Of 1965), the Single Convention on Narcotic Drugs, 1961, and the Convention on Psycotropic Substances, 1971; Regulation 20(4) And 20(7)(S), 10/04/20201Downloadapplication-forms formregulatory-compliance
Application for possession/research or analytical purpose, 12/02/20201Downloadapplication-forms formregulatory-compliance
GLF-LIC-04AForm for Licence Application for a Wholesaler to Export Medicines, 18/08/20221, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
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GLF-LIC-01AForm for Licence Application to Manufacture Import or Export Medicines Scheduled Substances including Contract Testing Laboratories, 18/08/20221, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-05AForm for Licence Application to Cultivate Manufacture or Import Cannabis for Medicinal Purposes, 10/08/20221, , , docxDownloadapplication-forms formcannabis inspectorate-and-good-manufacturing-practices licencing regulatory-compliance
WHO Global Model Regulatory Framework for Medical Devices including IVD medical devices, 26/01/20171wwwDownloadother-documents who-documentmedical-devices
8.10FAQ: Licencing of medical device establishments, 16/11/20171pdfDownloadfaq other-documentsmedical-devices
9.96Transitional Arrangements for Medical Devices, 27/04/20171pdfDownloadcommunication-to-industry position-statementmedical-devices
9.79Medical Device Establishments: License Requirements, 21/09/20161pdfDownloadcommunication-to-industry position-statementmedical-devices
9.78Disinfectants Status of Antiseptics and Germicides, 21/07/20161pdfDownloadcommunication-to-industry position-statementmedical-devices
9.106Class A Medical Devices, 14/09/20171pdfDownloadcommunication-to-industry position-statementmedical-devices
9.105Section 21 Authorisation of Sale Unregistered Medical Devices, 16/11/20171, , , pdfDownloadcommunication-to-industry position-statementemergency-use medical-devices section-21 unregistered-products
9.103Tissue Engineering Products, 16/11/20171pdfDownloadcommunication-to-industry position-statementmedical-devices
2.32Wound Dressings, 23/11/20111pdfDownloadcommunication-to-industry position-statementmedical-devices
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6.18Validation template CM24/06/20202Downloadtemplatescomplementary-medicines
OF-PEM-PRE-01IBiopharmaceutics Classification System (BCS) Based Biowaiver Application Form12/08/20224, , docxDownloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
OF-PEM-PRE-01HAdditional Strength Biowaiver Application Form18/08/20224, , docxDownloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
OF-PEM-PRE-01PQuality And Bioequivalence Abridged Review Template13/04/20231, , docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
OF-PEM-PRE-01JBioequivalence Trial Information Form (BTIF)19/08/20224, , docxDownloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
6.31Summary of Critical Regulatory Elements (SCoRE)19/11/20203docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
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GLF-HPA-03AValidation Template For ECTD Variation Applications16/05/20232docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
Outcome of Risk for Nitrosamine Investigation29/12/20211Downloadtemplatesgeneral-ectd-human-medicines-guidelines
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21.2MSA promethazine13/09/20071pdfDownloadsafety-alertspharmacovigilance
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8.04Contact details for Guideline 8.04 Recall, Adverse Event And Post- Marketing Vigilance Reporting Of Medical Devices And IVDs09/12/20211pdfDownloadcommunication-to-industrymedical-devices
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MD027Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs)12/03/20211docxDownloadcommunication-to-industrymedical-devices
MD025Alternative licensing and regulatory pathway for masks24/09/20201pdfDownloadcommunication-to-industrymedical-devices
MD025Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-1922/09/20201pdfDownloadcommunication-to-industrymedical-devices
MD024Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits19/09/20201pdfDownloadcommunication-to-industrymedical-devices
MD022Application Clinical Evaluation Medical Device IVD19/08/20201pdfDownloadcommunication-to-industrymedical-devices
MD021Use SARS CoV-2 Antibody Tests NDOH13/08/20201pdfDownloadcommunication-to-industrymedical-devices
MD020Certificate of Free Sale03/07/20202pdfDownloadcommunication-to-industrymedical-devices
MD019Processing of licence applications16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD018Specifications Molecular Test kits23/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD017Technical Review Application COVID-19 Molecular Test15/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD016Conditions of Use COVID-19 Serological Test Kits16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD015Process Flow Imported COVID-19 Test Kits17/03/20222pdfDownloadcommunication-to-industrymedical-devices
MD014Regulatory Requirements for Molecular Test Kits17/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD013Process Flow Locally Manufactured COVID-19 Test Kits17/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD012Notice of Contravention of Act 101 of 196531/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD011Licence Conditions for COVID-19 Serological Test Kits15/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD009Alternative Regulatory Licensing Requirements Alcohol-based sanitisers17/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD008ISO Standards for Medical Devices and Protective Clothing16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD007Specifications Serological Test kits14/07/20202pdfDownloadcommunication-to-industrymedical-devices
MD006Laboratory Testing and Use of COVID-19 Serological Test Kits09/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD005Expedited Regulatory Pathways for Medical Devices16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD003Testing for COVID-1909/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD002Regulatory Requirements for Serological Test Kits17/07/20202pdfDownloadcommunication-to-industrymedical-devices
MD001Regulatory Requirements for Medical Devices COVID-1916/07/20202pdfDownloadcommunication-to-industrymedical-devices
Communication to Stakeholders: Licensing of Complementary Medicines Manufacturers, Wholesalers, Distributors, Importers and Exporters26/02/20201pdfDownloadcommunication-to-industrycomplementary-medicines
REQUESTS: Existing Category D (Complementary Medicines) Registration Applications – COMPLEMENTARY MEDICINES APPLICATIONS SUBMITTED FOR REGISTRATION27/10/20211pdfDownloadcommunication-to-industrycomplementary-medicines
Review of detained product at a port of entry as a Category D medicine30/11/20211pdfDownloadcommunication-to-industrycomplementary-medicines
Application for a certificate of free sale for Category D medicines (Complementary Medicines)24/11/20211pdfDownloadcommunication-to-industrycomplementary-medicines
7.02updated – Roadmap and transitional process for the Regulation of complementary medicines08/12/20211pdfDownloadcommunication-to-industrycomplementary-medicines
Communication to industry on Clones and Replicas26/11/20201pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.19Communication to industry on metformin-containing medicines22/10/20201pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.18Communication to industry on ranitidine-containing medicines21/10/20201pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.17Communication to industry on the sartans-containing medicines22/10/20202pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
SAHPRA INVOLVEMENT IN THE SWISSMEDIC MARKETING AUTHORISATION FOR GLOBAL HEALTH PRODUCTS (MAGHP) PROCEDURE23/11/20211pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
17.05SAHPRA Payment Guideline15/09/20227pdfDownloadguidelinefinance
SAHPGL-CEM-CT-09Guideline for Clinical Trial Investigators24/10/20223pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-01Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events)05/09/20223pdfDownloadguidelineclinical-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
Clinical Trials Committee and Submission dates for 202224/06/20211pdfDownloadcommunication-to-industryclinical-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
GLF-CEM-PV-S01Valproate Annual Risk Acknowledgement Form18/08/20221pdfDownloadformpharmacovigilance
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
MD010Guidance Rapidly developed ventilator13/05/20201pdfDownloadcommunication-to-industrymedical-devices
MD004Extension – Use of acknowledgement letter in lieu of a licence05/03/20201pdfDownloadcommunication-to-industrymedical-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
5.08Revised Guideline – Donations of Medicines Medical Devices And IVDs16/04/20203pdfDownloadother-documentsmedical-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
9.129Re-submission of BAU New Medicines Applications from 2018 and 201920/10/20212Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
9.128Pilot: BAU new medicine applications for registration21/07/20212Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
9.127eCTD Implementation roadmap communication27/10/20212Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-05BAU Variations Communication07/09/20224, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
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 Guideline11/12/202312, 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
9.126Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-220/05/20211Downloadcommunication-to-industrybiological-medicines-evaluation-and-research
7.01Complementary Medicines – Discipline Specific Safety and efficacy25/06/20203pdfDownloadguidelinecomplementary-medicines
6.12Complementary Medicines Section 21 Application Form18/07/20131, Downloadapplication-formscomplementary-medicines section-21
8.02Medical Device IVD Essential Principles14/11/20192Downloadguidelinemedical-devices
GLF-MD-06ALicence Application Medical Device Manufacture, 22/11/20233xlsxDownloadapplication-forms formmedical-devices