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GLF-MD-11AMedical Device Adverse Event Reporting Form, 13/12/20241docxDownloadapplication-forms formmedical-devices
SAHPGL-MD-11Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)13/12/20241pdfDownloadguidelinemedical-devices
XR01-2024/25Introduction of Conditions for Veterinary X-Ray Licence Holders06/12/20241, pdfDownloadcommunication-to-industryradiation-control x-rays
RC02-2024/2025Absence of Border Medicines Control Technicians at the Ports of Entry on 29 November 202425/11/20241, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices regulatory-compliance
FN02-2024/25Submission Dates for Claims22/11/20241pdfDownloadcommunication-to-industryfinance
SAHPGL-RDN-INSP-01Guideline for the Sealing and Unsealing of Hazardous Substances19/11/20242, pdfDownloadguidelineinspectorate radiation-control
GLF-RDN-INSP-01CTemplate – Seal Letter19/11/20241, docxDownloadtemplatesinspectorate radiation-control
GLF-RDN-INSP-01BTemplate – Tech Unseal Letter19/11/20241, docxDownloadtemplatesinspectorate radiation-control
GLF-RDN-INSP-01ATemplate – Unseal Letter19/11/20241, docxDownloadtemplatesinspectorate radiation-control
PEM POST 04-2024/25Quality Variations11/11/20241, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines pem-post-reg
HPA16-2024/25SAHPRA Engagement Portal07/11/20241, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA15-2024/25Implementation of Regulatory Information Management System – Information on eCTD 3.1 Module 1 – Document Matrix29/10/20248, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA15-2024/25Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 125/10/20247, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
CT03-2024/25Clinical Trials Committee Meeting and Submission Dates for 202514/10/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
VET01-2024/25Communication to Industry – Request for Scientific Information on Yohimbine Use in Veterinary Medicine11/10/20241pdfDownloadcommunication-to-industryveterinary-medicines
Consolidated Schedules (6 September 2024)25/09/20241pdfDownloadconsolidated-schedulesnames-and-scheduling
CT02-2024/25Clinical Trial Applications – Investigational Product Import Licence25/09/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
DHCPLDHCPL – Tegretol S 100 mg Per 5 ml Carbamazepine Suspension23/09/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
Communication to Industry – Policy Position of SAHPRA on Enabling Local Manufacture17/09/20241pdfDownloadcommunication-to-industrycorporate
MD01-2023/24Mpox Diagnostic Tests13/09/20241pdfDownloadcommunication-to-industrymedical-devices
DHCPLDHCPL – Pseudoephedrine-Containing Medicines Risks of PRES and RCVS – iNova Pharmaceuticals03/09/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDHCPL – Pseudoephedrine-Containing Medicines Risks of PRES and RCVS – Adcock and other Collaborators03/09/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
Annual Report (2023/2024)30/08/20241wwwDownloadannual-reportcorporate
SAHPRA Annual Performance Plan 2024– 202530/08/20241pdfDownloadplanning-documentcorporate
GLF-PEM-02LSameness Declaration Form for Reliance-based Models20/08/20241, , docxDownloadformgeneral-ectd-human-medicines-guidelines hpa pem
CLINPR02-2024/25Phenylephrine Lack of Effectiveness of Oral Preparations as Nasal Decongestant01/08/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management general-ectd-human-medicines-guidelines
CLINPR01-2024/25Restriction on Codeine Use in Children, Pregnant and/or Breastfeeding Mothers01/08/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management general-ectd-human-medicines-guidelines
PEM-POST-02-2024_25Communication to Industry – FAQs on Active Pharmaceutical Ingredient23/07/20241pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
PEM-POST-01-2024/25Frequently asked questions (FAQs) and common deficiencies for the submission of PEM Post-Registration variations, 23/07/20245, pdfDownloadcommunication-to-industry faqgeneral-ectd-human-medicines-guidelines pem-post-reg
GLF-HPA-06BCTD Checklist23/07/20241docxDownloadformgeneral-ectd-human-medicines-guidelines
GLF-HPA-06AZ-Code Request Form23/07/20241docxDownloadformgeneral-ectd-human-medicines-guidelines
SAHPGL-CRO-02Guideline on Co-Applicancy16/07/20241pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
B-BBEE Policy for Issuance of Licences – for further comments09/07/20242pdfDownloadcommunication-to-industrylegal
HPA-15Communication to Industry – Implementation of the Regulatory Information Management System, Version 5 Portal & Interim DVP use09/07/20245, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
DHCPLGSK DHCPL – Risk of DRESS associated with use of aciclovir and valaciclovir-containing medicines08/07/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRecommended Calculations of Contraception Duration after Completion of Therapy with Genotoxic Anticancer Medicines – Dr Reddy’s Laboratories06/07/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRecommended Calculation of Contraception Duration After Completion of Therapy to Minimise Risk of Embryotoxicity and Teratogenicity Associated With the Use of Halaven® (Eribulin Mesylate)02/07/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
GLF-PEM-03ATemplate of Amendment Schedule to APIMF Holder01/07/20241docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
DHCPLDHCPL – IV Tranexamic Acid Risk of Intrathecal Administration Error – PharmaDynamics and other collaborators27/06/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLPseudoephedrine-containing Medicines – Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)21/06/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLGavreto (pralsetininb) DHCPL- Removal from the Pharmaceutical Market19/06/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
HPA-16ZA-SAHPRA CTD eSubmission Specification – Document for comment06/06/20243, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
MD01-2024/2025Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders09/07/20241pdfDownloadcommunication-to-industrymedical-devices
DHCPLDHCPL – Instruction for use for Sybrava Inclisiran single-dose pre-filled syringe31/05/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
A Signal Of Myocarditis / Pericarditis Associated With Pfizer-BioNTech’s Covid-19 Vaccine, Comirnaty (Bnt162b2)21/07/20211wwwDownloadcommunication-to-the-publicpharmacovigilance
SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines20/08/20211wwwDownloadcommunication-to-the-publicpharmacovigilance
HPA-15Communication to Industry – Implementation of Regulatory Information Management System – Update on Progress28/05/20246, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
PV05-2023/24Communication to Industry – Summary of Medicine Safety Regulatory Decisions27/05/20241pdfDownloadcommunication-to-the-publicpharmacovigilance
PV06-2023/24Communication to Industry – Summary of Medicine Safety Regulatory Decisions23/05/20241pdfDownloadcommunication-to-the-publicpharmacovigilance
GLF-HPA-07BLetter of Permission from HCR22/05/20241, docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines hpa
GLF-HPA-07ADeclaration of Sameness for Clones and Replicas22/05/20241, docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines hpa
DHCPLRisk of intrathecal administration error associated with intravenous (IV) tranexamic acid – Pfizer and other collaborators06/05/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
Expression of Interest for Medical Device Registration Voluntary Feasibility Study17/05/20241pdfDownloadcommunication-to-industrymedical-devices
RC02-2024/2025Physical Resubmission of Shipment Documentation for SAHPRA Review and Stamp16/05/20241, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices regulatory-compliance
GLF-PEM-02KCEP Letter of Access Template14/05/20241docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
RC01-2024/2025Delays in Shipment Release at OR Tambo International Airport10/05/20241, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices regulatory-compliance
Clinical Variations Fee Schedule and Explanatory Notes, 12/05/20211pdfDownloadcommunication-to-industry retention-notificationsfinance
9.124Explanatory Note on Fees Payable for Technical Amendments Related to Quality08/04/20212pdfDownloadcommunication-to-industryfinance
Annual retention fee payment notification for year ending 31 December 2024, 07/05/20241pdfDownloadcommunication-to-industry retention-notificationsfinance
Annual retention fee payment notification for the Financial year ending 31 March 2020, 23/04/20211pdfDownloadcommunication-to-industry retention-notificationsfinance
Annual retention fee payment notification for the Financial year ending 31 March 2022, 05/02/20211pdfDownloadcommunication-to-industry retention-notificationsfinance
DHCPLRecommended Calculations of Contraception Duration After Completion of Therapy with Genotoxic Anticancer Medicines (Sanofi and Other Collaborators)29/04/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLImportant Medicine Safety Information Section 36 Approval – Phenylephrine Hydrochloric Injectiontm30/04/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
CT01-2024/25South African Good Clinical Practice (GCP) Training Post Covid-19 Pandemic29/04/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
HPA-15Communication to Industry – Implementation of Regulatory Information Management System – Responses to queries in eSubmission format29/04/20243, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
DHCPLRecommended Calculations of Contraception Duration after Completion of Therapy with Genotoxic Anticancer Medicines (Sun Pharma and Other Collaborators)29/04/20241pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
HPA-15Communication to Industry – Implementation of Regulatory Information Management System (RIMS) – Update on Progress29/04/20242, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
PEM_Preg_01-2024/25EDQM CEP 2.0 Implementation29/04/20241, , pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
GLF-LIC-05BLicence Application for the Importing and the Distribution Scheduled Substances, 24/04/20241, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
SAHPGL-LIC-05GWP Guideline for the Importers and Distributors of Scheduled Substances24/04/20241pdfDownloadguidelinelicencing
SAHPRA IB Sealing and Unsealing11/04/20241, pdfDownloadcommunication-to-industryradiation-control radionuclides
Requests to use unregistered veterinary medicines under Section 21 of Act 101 of 196522/03/20242, , pdfDownloadcommunication-to-industrysection-21 unregistered-products veterinary-medicines
GLF-PEM-VET-01CSection 21 Emergency Medicines Bulk Application Form, 22/03/20242, , docxDownloadapplication-forms formsection-21 unregistered-products veterinary-medicines
FN01-2023/24Collection of Outstanding Retention Fees, 08/03/20241pdfDownloadcommunication-to-industry retention-notificationsfinance
HPA-15Communication to Industry – Implementation of Regulatory Information Management System06/03/20241, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Pharmacovigilance Process of Issuing Safety Recommendations to Applicants/HCRS For Implementation29/02/20241pdfDownloadcommunication-to-industrypharmacovigilance
GLF-RDN-RN-02AApplication Form of The Renewal of Authority to Acquire, Possess, Use, Convey and/or Distribute Radioactive Nuclides29/02/20241, docxDownloadformradiation-control radionuclides
RN01-2023/24Minimum Requirements For Establishment of Internal Rules29/02/20241, pdfDownloadcommunication-to-industryradiation-control radionuclides
African Medicines Regulatory Harmonization 2023 Highlights14/02/20241pdfDownloadnewslettercorporate
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 SAHPRA30/01/20242docxDownloadformregulatory-compliance
GLF-RC-INSP-05BRecall Letter to customers, 30/01/20242docxDownloadform templatesregulatory-compliance
GLF-RC-INSP-05ARecall Information30/01/20242docxDownloadformregulatory-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 Renewals09/09/20244docxDownloadtemplatesgeneral-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 December 2023, 08/06/20231pdfDownloadcommunication-to-industry retention-notificationsfinance
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
02/2022/23Communication to Industry – Summary of Medicine Safety Regulatory Decisions02/06/20231pdfDownloadcommunication-to-the-publicpharmacovigilance
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)04/06/20242, docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
03/2022/23Summary of Medicine Safety Regulatory Decisions13/04/20231pdfDownloadcommunication-to-the-publicpharmacovigilance
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
GLF-RDN-RN-07I (Previously RN528)Application for Cancellation of Authority to Handle Radioactive Material20/05/20242, docxDownloadformradiation-control radionuclides
HPA-11Communication on Hard Copy Registration Certificates17/02/20231, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
GLF-RDN-NM-06B (Previously SBVETMR-1)Application for a Licence to Use, Operate, Apply Install or Keep Installed an MRI Device System (Veterinary)18/11/20242, docxDownloadformnirmed radiation-control
GLF-RND-NM-06C (Previously SBMR-1)Application for a Licence to Use Operate Apply Install or Keep Installed a Magnetic Resonance Imaging (MRI) Device System (Medical)18/11/20242, docxDownloadformnirmed 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 Product18/11/20242, 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 (Previously 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 Framework31/07/20247pdfDownloadcommunication-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
GLF-RDN-RN-07E (Previously RN800)Notice of Complaint20/05/20242, docxDownloadformradiation-control radionuclides
RN855App_Maintenance work on apparatus with sealed RS07/12/20211, Downloadformradiation-control radionuclides
GLF-RDN-RN-14B (Previously RN789)Application to convey or transport radionuclides26/07/20242, docxDownloadformradiation-control radionuclides
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RN786AApp_RPA Radiation Protection Adviser07/12/20211, Downloadformradiation-control radionuclides
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GLF-RDN-RN-17A (Previously RN782)Export application07/12/20221, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-07C (Previously RN781a)Confirmation of Import of Sources20/05/20241, docxDownloadformradiation-control radionuclides
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RN780Log for sealed gamma radiography sources07/12/20211, Downloadformradiation-control radionuclides
RN778App_Register industrial radiographer13/12/20211, Downloadformradiation-control radionuclides
GLF-RDN-RN-07J (Previously RN621)Application to Release Old Sealed Sources from NLM NECSA Storage20/05/20241, docxDownloadformradiation-control radionuclides
RN608Particulars of sealed radioactive sources08/12/20211, Downloadformradiation-control radionuclides
RN607Medical report08/12/20211, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-07B (Previously RN527 & RN787A)Application for a Change of Details of an Authority Holder and Physical Facilities for the Handling, Use and Storage of Unsealed Radionuclides20/05/20242, docxDownloadformradiation-control radionuclides
WIF-RDN-RN-02B.H (Previously RN526)Application for disposal sale of radionuclides26/07/20242, docxDownloadformradiation-control radionuclides
RN525iApp_Discard sealed sources09/12/20211, docxDownloadformradiation-control radionuclides
WIF-RDN-RN-02B.G (Previously RN525)Application to discard remove sealed radioactive sources26/07/20242, docxDownloadformradiation-control radionuclides
WIF-RDN-RN-02B.F (Previously RN524)Application to discard dispose sealed radioactive material26/07/20242, docxDownloadformradiation-control radionuclides
WIF-RDN-RN-02B.E (Previously RN523)Application to dispose of liquid radioactive material26/07/20242, 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
8.01 (Archived)General Information Medical Devices And IVDs13/08/20141Downloadguidelinemedical-devices
8.06 (Archived)Guideline For Access To And Control Of Medical Devices And IVDs18/04/20171Downloadguidelinemedical-devices
SAHPGL-CEM-PV-03Risk Management Plans for Medicines for Human Use15/09/20221pdfDownloadguidelinepharmacovigilance
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 Form Template01/07/20242docxDownloadformgeneral-ectd-human-medicines-guidelines
GLF-PEM-02BTemplate of Standardised Content of Letter of Access01/07/20242docxDownloadtemplatesgeneral-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
GLF-PEM-VET-05BOwner Consent Form (Use of an Unregistered Veterinary Product), 26/08/20241docxDownloadapplication-forms formveterinary-medicines
OF-PEM-VET-01CVeterinary Clinical Trial Application Template, , 26/08/20243, docxDownloadapplication-forms form templatesclinical-trials veterinary-medicines
GLF-PEM-VET-01AVeterinary Medicines Section 21 Application Form, 22/03/20242, , docxDownloadapplication-forms formsection-21 unregistered-products veterinary-medicines
GLF-PEM-VET-01BProgress Report Form After Use of An Unregistered Product, 22/03/20243, , , 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
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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
SAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals, 07/04/20211wwwDownloadcommunication-to-health-care-professionals communication-to-the-publicpharmacovigilance
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
DHCPLSelective Serotonin Reuptake Inhibitors (SSRIS) and Serotonin–Norepinephrine Reuptake Inhibitors (SNRIS) associated with the risk of Postpartum Haemorrhage19/06/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
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
DHCPLVSIQQ® (Brolucizumab) – A Requirement to Discontinue Treatment with Vsiqq® in Patients who Develop Retinal Vasculitis and/or Retinal Vascular Occlusion, Typically in the Presence of Intraocular Inflammation24/11/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLTopical Corticosteroid – Risk of Withdrawal Reactions – Aspen16/08/20222pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
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
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SAHPGL-RDN-XR-02Guideline For Code Of Practice For Users Of Medical Xray Equipment17/08/20221, pdfDownloadguidelineradiation-control x-rays
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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
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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
SAHPGL-RDN-RN-06 (Old UNSEAL)Guideline For Safe Use of Unsealed Radioactive Nuclides01/02/20241, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-14 (Old TRUG91-1)Guideline For The Safe Transport of Radioactive Material20/02/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-15Identification and Labelling of Radioactive Sources and Source Containers08/02/20242, pdfDownloadguidelineradiation-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
SAHPGL-RDN-RN-04 (Old IRCP91-2)Guideline for Industrial Radiography18/06/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-08 (Old GAUGE)Guideline For The Safe Use of Industrial Gauges Containing Radioactive Sources01/02/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-01 (Old FIRE)Guideline on Protective Measures To Take In The Event of an Accident Involving Radioactivity01/02/20242, pdfDownloadguidelineradiation-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
SAHPGL-RDN-RN-03Guideline on The Safe Use of Soil Moisture and Density Gauges Containing Radioactive Sources01/02/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-02Guideline On The Organisational Requirements For Authority Holders And Their Appointed Radiation Protection Officers01/02/20242, pdfDownloadguidelineradiation-control radionuclides
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SAHGPL-RDN-XR-19Guideline for Management of Pregnant Radiographers and Other Staff Members07/09/20221, , pdfDownloadguidelineradiation-control radionuclides x-rays
SAHPGL-RDN-RN-17Guideline on Requests for Medical Examinations for Radiation Workers20/02/20242, pdfDownloadguidelineradiation-control radionuclides
2.21South African Specification for eCTD Regional Module111/03/20243.1pdfDownloadguidelinegeneral-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 medicines22/03/20243, , , pdfDownloadguidelineemergency-use section-21 unregistered-products veterinary-medicines
Guideline on completion of the veterinary medicines clinical trial application form19/09/20191, , , Downloadguidelineclinical-evaluations-management clinical-trials quality veterinary-medicines
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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 Process09/09/20245, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa veterinary-medicines
PEM01-2024/25Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals15/05/20242pdfDownloadcommunication-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 Alerts15/02/20244pdfDownloadguidelineregulatory-compliance
01/2022/23Summary of Medicines Safety Regulatory Decisions23/06/20221pdfDownloadcommunication-to-the-publicpharmacovigilance
SAHPGL-CEM-PV-04Post-marketing Reporting Of Adverse Drug Reactions To Human Medicines In South Africa08/06/20229pdfDownloadguidelinepharmacovigilance
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
SAHPRA’s Annual Performance Plan: 2019-202019/09/20191pdfDownloadpresentationscorporate
SA’s Covid-19 epidemic: Trends & Next steps15/04/20201pdfDownloadpresentationsndoh
The Status of Cannabis for Medicinal and Research Purposes23/10/20191, , pdfDownloadpresentationscannabis names-and-scheduling regulatory-compliance
Cannabis and Related Substances Legislation and Regulation18/03/20211, , pdfDownloadpresentationscannabis names-and-scheduling regulatory-compliance
Parliamentary Portfolio Committee On Health- Covid-1916/04/20201pptxDownloadpresentationscorporate
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
SAHPRA’s Vaccine Authorisation Process23/09/20211pdfDownloadpresentationsbiological-medicines-evaluation-and-research
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
SAHPGL-PEM-BIO-01Guideline for Lot Release of Human Vaccines08/06/20234pdfDownloadguidelinebiological-medicines-evaluation-and-research
Payment of annual retention fees for registered products25/05/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
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
VigiGuardian Newsletter April 202228/04/20221wwwDownloadnewsletterpharmacovigilance
SAHPRA backlog clearance programme newsletter August 202020/08/20201pdfDownloadnewsletterbacklog
Cannabis and related substances27/02/20201pdfDownloadnewsletterregulatory-compliance
SAHPGL-PEM-BIO-06General guidance document on QSE for Biological Medicines24/08/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
MD033Specification criteria for COVID-19 rapid antigen selftests18/03/20221pdfDownloadcommunication-to-industrymedical-devices
Conformity of assessment body DoC template, 30/03/20221docxDownloadcommunication-to-industry templatesmedical-devices
Conformity assessment body(cab) requirements for recognition by Sahpra checklist, 24/03/20221pdfDownloadchecklist communication-to-industrymedical-devices
MD035Usability studies for Covid-19 self-testing kits requirements24/03/20221pdfDownloadcommunication-to-industrymedical-devices
MD034Conditions for use of COVID-19 antigen self-test kits17/03/20221pdfDownloadcommunication-to-industrymedical-devices
MD032ISO 13485 Conformity Assessment Body Communication19/08/20222pdfDownloadcommunication-to-industrymedical-devices
Communication to Stakeholders with regards to the current status of the Medical Device Regulations23/03/20221pdfDownloadcommunication-to-industrymedical-devices
Upcoming SAHPRA and Industry workshop17/03/20221pdfDownloadcommunication-to-industrymedical-devices
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
SAHPGL-HPA-08Multiple Applications Guideline11/12/20233, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa
MD031Medical Device Establishment Licence Renewal Process22/09/20222pdfDownloadcommunication-to-industrymedical-devices
MD030Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication02/02/20221pdfDownloadcommunication-to-industrymedical-devices
Annual Report (2018/2019)15/05/20191pdfDownloadannual-reportcorporate
Annual Report (2019/2020)28/05/20201pdfDownloadannual-reportcorporate
Annual Report (2020/2021)13/05/20211pdfDownloadannual-reportcorporate
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
GLF-CEM-CT-01BClinical Trial Application Form – Guidance in conditions of a Public Health Emergency, 08/06/20222, docxDownloadapplication-forms formclinical-trials emergency-use
GLF-CEM-CT-01AClinical Trial Application Form, 18/09/20228docxDownloadapplication-forms formclinical-trials
GLF-CEM-CT-01ENotification Studies: Phase IV, 01/10/20235docxDownloadapplication-forms formclinical-trials
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
GLF-LIC-02ALicence Application to act as a Wholesaler of Medicines and Scheduled Substances, 18/08/20221, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
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
Reprocessing of Single Use Medical Devices Communication to Stakeholders, 20/11/20191pdfDownloadcommunication-to-industry position-statementmedical-devices
Communication to Industry Licence Amendment, 27/11/20191pdfDownloadcommunication-to-industry position-statementmedical-devices
Communication to Industry Licence Acknowledgement Letter, 28/11/20191pdfDownloadcommunication-to-industry position-statementmedical-devices
GLF-MD-06BLicence Application Medical Device Wholesaler Form, 03/09/20244xlsxDownloadapplication-forms formmedical-devices
GLF-MD-06CLicence Application to Import Distribute or Export Medical Devices, 03/09/20244xlsxDownloadapplication-forms formmedical-devices
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
6.30New Registration Validation Template for eSubmission17/07/20191Downloadtemplatesgeneral-ectd-human-medicines-guidelines
6.16New Registration Validation Template for eCTD17/07/20193Downloadtemplatesgeneral-ectd-human-medicines-guidelines
SAHPRA Variation Validation Template for eSubmission27/02/20201Downloadtemplatesgeneral-ectd-human-medicines-guidelines
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
Notification Template 2 for Nitrosamine Confirmatory Testing15/12/20211Downloadtemplatesgeneral-ectd-human-medicines-guidelines
Notification Template 1 for Nitrosamine Risk Evaluation31/12/20211Downloadtemplatesgeneral-ectd-human-medicines-guidelines
OF-HPA-06ASAHPRA Pre-Submission Meeting Request Form05/08/20212, docxDownloadformgeneral-ectd-human-medicines-guidelines hpa
21.1MSA ketoconazole and domperidone12/07/20061pdfDownloadsafety-alertspharmacovigilance
21.3MSA Rotarix12/03/20081pdfDownloadsafety-alertspharmacovigilance
21.2MSA promethazine13/09/20071pdfDownloadsafety-alertspharmacovigilance
21.4MSA atypical antipsychotics24/06/20092pdfDownloadsafety-alertspharmacovigilance
21.6MSA cough and cold medicines20/06/20121pdfDownloadsafety-alertspharmacovigilance
21.5MSA gamma benzine hexachloride22/06/20121pdfDownloadsafety-alertspharmacovigilance
21.9Communication to industry on metformin-containing medicines, 14/10/20201Downloadcommunication-to-industry safety-alertspharmacovigilance
21.8Communication to industry on ranitidine-containing medicines, 22/10/20201Downloadcommunication-to-industry safety-alertspharmacovigilance
DIPHENHYDRAMINE-CONTAINING MEDICINES30/11/20201pdfDownloadsafety-alertspharmacovigilance
A SIGNAL OF MYOCARDITIS / PERICARDITIS ASSOCIATED WITH PFIZER-BIONTECH’S COVID-19 VACCINE, COMIRNATY (BNT162B2)19/08/20211pdfDownloadsafety-alertspharmacovigilance
Communication to industry on Post Marketing Reporting of ADRs guideline31/05/20211pdfDownloadcommunication-to-industrypharmacovigilance
SAHPRA survey to determine company turnover31/03/20211, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices licencing
GMP CERTIFICATES FOR CANNABIS CULTIVATED BY CULTIVATORS HOLDING A SECTION 22C(1)(b) LICENCE (LICENCE TO CULTIVATE CANNABIS FOR THE PURPOSES OF PRODUCING SCHEDULED SUBSTANCES)25/03/20211, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices licencing
MD029Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators24/06/20211pdfDownloadcommunication-to-industrymedical-devices
MD028Communication Retention Fees27/05/20211pdfDownloadcommunication-to-industrymedical-devices
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
SAHPGL-FIN-01SAHPRA Payment Guideline12/02/20248pdfDownloadguidelinefinance
SAHPGL-CEM-CT-09Guideline for Clinical Trial Investigators24/10/20223, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-01Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events)05/09/20223, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-06Procedure for Consultation Meetings with Clinical Trial Applicants11/08/20222, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-05Liability Insurance for Clinical Trials17/08/20223, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-02Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model01/07/20222, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-08Guideline for Capacity Building and Transformation in Clinical Research in South Africa01/10/20222, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-04Oversight and Monitoring in Clinical Trials01/08/20224, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-07Post Clinical Trial Access03/08/20224, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-03Emergency Procedures for Clinical Trial Sites17/08/20223, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-10Safety Reporting During Clinical Trials06/10/20225, pdfDownloadguidelineclinical-evaluations-management clinical-trials
Clinical Trials Committee and Submission dates for 202224/06/20211pdfDownloadcommunication-to-industryclinical-trials
SA Good Clinical Practice Guidelines17/06/20203, pdfDownloadguidelineclinical-evaluations-management clinical-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 IVDs15/03/20244pdfDownloadguidelinemedical-devices
SAHPGL-MD-03 (previously 8.04)Guideline for Medical Device Adverse Event Reporting13/12/20244pdfDownloadguidelinemedical-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
SAHPGL-BAU-01Reliance Guideline15/05/20244pdfDownloadguidelinegeneral-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) Procedure23/07/20244, , 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)26/04/20246, , pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
SAHPGL-CEM-03Guideline for Patient Information Leaflet for Human Medicines (Categories A D)27/05/20248, , 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 guideline23/05/20238, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines veterinary-medicines
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 Guidance14/08/20203pdfDownloadguidelinebiological-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
GLF-PEM-COMP-01AComplementary Medicines Section 21 Application Form07/08/20241, docxDownloadapplication-formscomplementary-medicines section-21
8.02 (Archived)Medical Device IVD Essential Principles14/11/20192Downloadguidelinemedical-devices
GLF-MD-06ALicence Application Medical Device Manufacture, 03/09/20244xlsxDownloadapplication-forms formmedical-devices