Safety Information and Updates - SAHPRA

Safety Information Updates/Pharmacovigilance

No therapeutic product is ever completely risk free. Some risks may be known when a medicine is first entered on the market. However, some information only comes to light after more people use the products.

 

This webpage was developed to provide the public and healthcare professionals with easy access to important drug safety information. The webpage contains the most recent drug safety communications from SAHPRA as well as links for early communications and follow-up.

 

Alerts provide important information and recommendations about therapeutic products. When an alert is issued, it does not necessarily mean a product is considered unsafe.

Vigilance Communication to Industry

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
VETPV 01 2025/26Format for Dear Veterinary Professional Letter Template29/09/20261, Downloadcommunication-to-industrypharmacovigilance veterinary-medicines
PV 03-2026/27SAHPRA Integrates the National Immunisation Safety Expert Committee (NISEC) into its Governance and Administrative Framework15/09/20261, Downloadcommunication-to-industryclinical-evaluations-management pharmacovigilance
PV02-2026/27Pharmacovigilance and Clinical Trials Units | SAHPRA Industry Consultation on e-Reporting VigiFlow Platform27/07/20261, , Downloadcommunication-to-industryclinical-evaluations-management clinical-trials pharmacovigilance
PV01-2026/27Mandatory call up for holders of certificates of registration to submit post marketing adverse event reports for human medicines (serious and non-serious) through Industry e- Reporting VigiFlow module24/06/20261, Downloadcommunication-to-industryinspectorate pharmacovigilance
PV03-2025/26Request for Submission of Latest PSMF and Product/PV Resourcing Information04/11/20251, Downloadcommunication-to-industryinspectorate pharmacovigilance
PV02-2025/26Amendment of the training dates for the MedDRA Training10/10/20251Downloadcommunication-to-industrypharmacovigilance
Pharmacovigilance Process of Issuing Safety Recommendations to Applicants/HCRS For Implementation29/02/20241Downloadcommunication-to-industrypharmacovigilance
Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting18/08/20221Downloadcommunication-to-industrypharmacovigilance
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
Communication to industry on Post Marketing Reporting of ADRs guideline31/05/20211Downloadcommunication-to-industrypharmacovigilance

Vigilance Guidelines

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-CEM-PV-08Guideline for Industry e-reporting19/08/20261Downloadguidelinepharmacovigilance
SAHPGL-CEM-PV-03Risk Management Plans for Medicines for Human Use15/09/20221Downloadguidelinepharmacovigilance
SAHPGL-CEM-PV-04Post-marketing Reporting of Adverse Drug Reactions for Human Medicines in South Africa27/08/202611Downloadguidelinepharmacovigilance
SAHPGL-CEM-PV-02Pharmacovigilance systems06/06/20232Downloadguidelinepharmacovigilance
SAHPGL-CEM-PV-01Pharmacovigilance Inspections for Human Medicinal Products10/05/20221Downloadguidelinepharmacovigilance
SAHPGL-CEM-PV-05Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety25/08/20226Downloadguidelinepharmacovigilance
SAHPGL-CEM-PV-06Guideline for Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals23/10/20254Downloadguidelinepharmacovigilance

Vigilance Forms

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
GLF-CEM-PV-04ASignal Notification/ Follow-up Form03/10/20251Downloadformpharmacovigilance
ALL VACCINES including COVID-19 : Case Reporting Form (CRF) for Adverse Events Following Immunisation (AEFI)29/01/20211Downloadformpharmacovigilance
COVID-19: Case Reporting Form (CRF) for suspected Adverse Events of Special Interest (AESI)28/01/20211Downloadformpharmacovigilance
ALL VACCINES including COVID-19: Case Investigation Form (CIF) Adverse Events Following Immunisation (AEFI) AND Adverse Events of Special Interest (AESI)28/01/20211Downloadformpharmacovigilance
GLF-CEM-PV-06AAdverse Drug Reactions and Quality Problem Reporting Form22/11/20233Downloadformpharmacovigilance
GLF-CEM-PV-S01Valproate Annual Risk Acknowledgement Form13/05/20252Downloadformpharmacovigilance

Vigilance Communication to Health Care Professionals

TitleDate UpdatedUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
Topiramate – Risk of Neurodevelopment Disorders Associated With Use in Pregnancy21/04/2026Downloadcommunication-to-health-care-professionalspharmacovigilance
Levetiracetam – Risk of Drug Reaction With Eosinophilia and Systemic Symptoms (Dress)27/03/2026Downloadcommunication-to-health-care-professionalspharmacovigilance
Clobazam – Risk of Drug Reaction With Eosinophilia and Systemic Symptoms (Dress)27/03/2026Downloadcommunication-to-health-care-professionalspharmacovigilance
Corenza-c® Effervescent Tablets (C661 (Act 101/1965)): Amendment to Product Labelling – Not to Be Used in Children Under 12 Years of Age15/10/2025Downloadcommunication-to-health-care-professionalspharmacovigilance
Valproate-containing Medicines – Potential Risk of Neurodevelopmental Disorders in Offspring of Fathers Treated With Valproate in the Three Months Prior to Conception03/10/2025Downloadcommunication-to-health-care-professionalspharmacovigilance
Pseudoephedrine-containing medicines – Risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)11/06/2025Downloadcommunication-to-health-care-professionalspharmacovigilance
Anviro® (Valaciclovir – Containing Medicine)– Risk of Drug Reaction With Eosinophilia and Systemic Symptoms (Dress)23/05/2025Downloadcommunication-to-health-care-professionalspharmacovigilance
Anagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation30/04/2025Downloadcommunication-to-health-care-professionalspharmacovigilance
Topical Corticosteroids – Risk of Withdrawal Reactions30/04/2025Downloadcommunication-to-health-care-professionalspharmacovigilance
Pseudoephedrine-containing medicines – Risks of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS) – Reckit09/04/2025Downloadcommunication-to-health-care-professionalspharmacovigilance
Pseudoephedrine-containing Medicines Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS) – J&J27/05/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Topiramate – Risk of Neurodevelopmental Disorders31/03/2025Downloadcommunication-to-health-care-professionalspharmacovigilance
The Risk of Meningioma Associated With the Use of Medroxyprogesterone Acetate27/02/2025Downloadcommunication-to-health-care-professionalspharmacovigilance
DHCPL – Tegretol S 100 mg Per 5 ml Carbamazepine Suspension23/09/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
DHCPL – Pseudoephedrine-Containing Medicines Risks of PRES and RCVS – iNova Pharmaceuticals03/09/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
DHCPL – Pseudoephedrine-Containing Medicines Risks of PRES and RCVS – Adcock and other Collaborators03/09/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
GSK DHCPL – Risk of DRESS associated with use of aciclovir and valaciclovir-containing medicines08/07/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Recommended Calculations of Contraception Duration after Completion of Therapy with Genotoxic Anticancer Medicines – Dr Reddy’s Laboratories06/07/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Recommended Calculation of Contraception Duration After Completion of Therapy to Minimise Risk of Embryotoxicity and Teratogenicity Associated With the Use of Halaven® (Eribulin Mesylate)02/07/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
DHCPL – IV Tranexamic Acid Risk of Intrathecal Administration Error – PharmaDynamics and other collaborators27/06/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Pseudoephedrine-containing Medicines – Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)21/06/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Gavreto (pralsetininb) DHCPL- Removal from the Pharmaceutical Market19/06/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
DHCPL – Instruction for use for Sybrava Inclisiran single-dose pre-filled syringe31/05/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Risk of intrathecal administration error associated with intravenous (IV) tranexamic acid – Pfizer and other collaborators06/05/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Recommended Calculations of Contraception Duration After Completion of Therapy with Genotoxic Anticancer Medicines (Sanofi and Other Collaborators)29/04/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Important Medicine Safety Information Section 36 Approval – Phenylephrine Hydrochloric Injectiontm30/04/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Recommended Calculations of Contraception Duration after Completion of Therapy with Genotoxic Anticancer Medicines (Sun Pharma and Other Collaborators)29/04/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Pharmacare and Multiple Collaborators DHCPL: Valaciclovir/Aciclovir – Containing Medicines – Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)19/01/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Valaciclovir-Aciclovir-Containing Medicines Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)10/01/2024Downloadcommunication-to-health-care-professionalspharmacovigilance
Potential Missing Professional Information (PI) and Patient Information Leaflet (PIL) in Folding Boxes of Pertjeta® 420 mg/14 mL infusion (pertuzumab)30/11/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
Potential Missing Professional Information (PI) and Patient Information Leaflet (PIL) in Folding Boxes of Hemlibra® 60 mg/0,4 mL solution for injection (emicizumab):30/11/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
The risk of acute tubulointerstitial nephritis (TIN) associated with proton pump inhibitors (PPIs)30/10/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
Golimumab SIMPONI® 50 mg: Important Changes to the Instructions For Use (IFU) for the SmartJect® Autoinjector/Pre-filled Pen04/10/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
Section 36 approval – KLACID XL04/09/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
Section 36 Approval – MeasBio Vaccine17/07/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
Bupropion Containing Medicines – Risk Of Brugada Syndrome (Adcock, Tev, Acino, and SunPharma)22/05/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
Bupropion containing medicines – Risk of of Brugada Syndrome (GSK)08/06/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
Synthroid – Range of tablets: Typing error in Professional Information (PI) and Patient Information Leaflet (PIL)21/05/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
Gabapentinoids – Risk of Serious Breathing Difficulty18/04/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
DHCPL_Section 36 approval – Measbio vaccine12/04/2023Downloadcommunication-to-health-care-professionalspharmacovigilance
Topical corticosteroids – DHCPL – Risk of withdrawal reactions19/10/2022Downloadcommunication-to-health-care-professionalspharmacovigilance
Anagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation17/08/2022Downloadcommunication-to-health-care-professionalspharmacovigilance
Cefepime hydrochloride – Risk of serious adverse reactions17/04/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Valproate containing medicines – High risk of congenital abnormalities and development disorders03/04/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Clozapine – Induced gastrointestinal hypomotility17/04/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Hydrochlorothiazide – Risk of non-menoloma skin cancer10/04/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Lamotrigine – Risk of Hemophagocytic Lymphohistiocytosis17/04/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Hyoscine Butylbromide – Risk of adverse effects in patients with underlying cardiac disease03/04/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Amphotericin B – Risk of Medication Error10/04/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
EPOETIN ALFA – New warnings on severe cutaneous adverse reaction11/04/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Gadolinium-Based Contrast Agents – Deposition in the brain11/04/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Dolutegravir – Risk of neural tube defects09/04/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers13/06/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers13/06/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers17/07/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers16/08/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers – 1 August 201916/08/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Increased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Pradaxa16/08/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Increased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Xarelto15/08/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Increased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Eliquis13/09/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
DHCPL for ACE-inhibitor/Angiotensin receptor blocker containing medicines11/10/2019Downloadcommunication-to-health-care-professionalspharmacovigilance
Fluoroquinolones: risk of mitral and aortic regurgitation associated with the use of oral and injectable fluoroquinolones10/06/2020Downloadcommunication-to-health-care-professionalspharmacovigilance
Sandoz and Novartis: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy12/06/2020Downloadcommunication-to-health-care-professionalspharmacovigilance
Ondansetron: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy12/06/2020Downloadcommunication-to-health-care-professionalspharmacovigilance
Tyrosine kinase inhibitors18/06/2020Downloadcommunication-to-health-care-professionalspharmacovigilance
Fluoropyrimidine containing medicines and related substances: Increased drug exposure and toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency22/10/2020Downloadcommunication-to-health-care-professionalspharmacovigilance
Risk of dopamine dysregulation syndrome (DDS) associated with the use of dopaminergic medicines used for the treatment of Parkinson’s disease (PD).25/11/2021Downloadcommunication-to-health-care-professionalspharmacovigilance
Tecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) and Immune-related myositis19/11/2020Downloadcommunication-to-health-care-professionalspharmacovigilance
Dopaminergic medicines used in the treatment of parkinson’s disease: Risk of Dopamine dysregulation syndrome22/10/2020Downloadcommunication-to-health-care-professionalspharmacovigilance
Diphenhydramine-containing Medicines20/11/2020Downloadcommunication-to-health-care-professionalspharmacovigilance
Eltroxin 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.09/12/2020Downloadcommunication-to-health-care-professionalspharmacovigilance
Increased Risk Of Subclinical Acute Interstitial Nephritis Associated With The Use Of Proton Pump Inhibitors (Ppis) Leading To Acute Kidney Injury And/or Chronic Renal Failure11/02/2021Downloadcommunication-to-health-care-professionalspharmacovigilance
Risk Of Drug Induced Liver Injury Associated With The Use Of Metamizole-containing Medicines18/03/2021Downloadcommunication-to-health-care-professionalspharmacovigilance
SAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals07/04/2021Downloadcommunication-to-health-care-professionals communication-to-the-publicpharmacovigilance
COVID-19 Vaccine Janssen: Risk of Thrombosis in combination with Thrombocytopenia18/11/2021Downloadcommunication-to-health-care-professionalspharmacovigilance
Dopaminergic Medicines used in the treatment of Parkinson’s Disease: Risk of Dopamine Dysregulation Syndrome13/05/2021Downloadcommunication-to-health-care-professionalspharmacovigilance
Selective Serotonin Reuptake Inhibitors (SSRIS) and Serotonin–Norepinephrine Reuptake Inhibitors (SNRIS) associated with the risk of Postpartum Haemorrhage19/06/2021Downloadcommunication-to-health-care-professionalspharmacovigilance
COVID-19 Vaccine Janssen23/07/2021Downloadcommunication-to-health-care-professionalspharmacovigilance
SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines12/08/2021Downloadcommunication-to-health-care-professionalspharmacovigilance
COMIRNATY® (COVID-19 mRNA Vaccine) -Warning regarding rare cases of Myocarditis and Pericarditis13/08/2021Downloadcommunication-to-health-care-professionalspharmacovigilance
VSIQQ® (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 Inflammation24/11/2021Downloadcommunication-to-health-care-professionalspharmacovigilance
Topical Corticosteroid – Risk of Withdrawal Reactions – Aspen16/08/2022Downloadcommunication-to-health-care-professionalspharmacovigilance

Vigilance Communication to the Public

TitleDate UpdatedUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
Summary of Medicine Safety Regulatory Decisions10/09/2025Downloadcommunication-to-the-publicpharmacovigilance
Summary of Medicine Safety Regulatory Decisions29/09/2025Downloadcommunication-to-the-publicpharmacovigilance
Summary of Medicines Safety Regulatory Decisions13/11/2025Downloadcommunication-to-the-publicpharmacovigilance
Summary of Medicines Safety Regulatory Decisions30/10/2025Downloadcommunication-to-the-publicpharmacovigilance
Summary of Medicine Safety Regulatory Decisions27/07/2025Downloadcommunication-to-the-publicpharmacovigilance
Summary of Medicine Safety Regulatory Decisions28/08/2025Downloadcommunication-to-the-publicpharmacovigilance
Summary of Medicine Safety Regulatory Decisions02/07/2025Downloadcommunication-to-the-publicpharmacovigilance
Communication to Industry – Summary of Medicine Safety Regulatory Decisions (PV04-2023/24)15/05/2024Downloadcommunication-to-the-publicpharmacovigilance
A Signal Of Myocarditis / Pericarditis Associated With Pfizer-BioNTech’s Covid-19 Vaccine, Comirnaty (Bnt162b2)21/07/2021Downloadcommunication-to-the-publicpharmacovigilance
SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines20/08/2021Downloadcommunication-to-the-publicpharmacovigilance
Communication to Industry – Summary of Medicine Safety Regulatory Decisions27/05/2024Downloadcommunication-to-the-publicpharmacovigilance
Communication to Industry – Summary of Medicine Safety Regulatory Decisions23/05/2024Downloadcommunication-to-the-publicpharmacovigilance
Communication to Industry – Summary of Medicine Safety Regulatory Decisions02/06/2023Downloadcommunication-to-the-publicpharmacovigilance
Summary of Medicine Safety Regulatory Decisions13/04/2023Downloadcommunication-to-the-publicpharmacovigilance
SAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals07/04/2021Downloadcommunication-to-health-care-professionals communication-to-the-publicpharmacovigilance
Summary of Medicines Safety Regulatory Decisions23/06/2022Downloadcommunication-to-the-publicpharmacovigilance

Vigilance Newsletters

TitleDate UpdatedUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
Medi-Guardian Newsletter September 202630/09/2026Downloadnewsletterpharmacovigilance
Medi-Guardian Newsletter November 202512/11/2025Downloadnewsletterpharmacovigilance
ReguLetter | First Edition | April – June 202514/08/2025, Downloadnewsletterinspectorate pharmacovigilance
Medi-Guardian Newsletter November 202330/11/2023Downloadnewsletterpharmacovigilance
VigiGuardian Newsletter July 202214/07/2022Downloadnewsletterpharmacovigilance
VigiGuardian Newsletter April 202228/04/2022Downloadnewsletterpharmacovigilance

Vigilance Manual

TitleDate UpdatedUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
Manual for Surveillance and Response to Adverse Events Following Immunisation30/09/2026Downloadguide manualpharmacovigilance
Pharmacovigilance Reference Manual for Healthcare Professionals in South Africa30/09/2026Downloadguide manualpharmacovigilance
Pharmacovigilance Training Manual30/09/2026Downloadguide manualpharmacovigilance
Handbook for Reporting Adverse Events, Product Quality Problems and Other Health Product Related Issues30/09/2026Downloadguide manualpharmacovigilance
Vaccine Safety Surveillance (VSS) In South Africa09/10/2023Downloadguide manualpharmacovigilance

Medicine Safety Alerts

Medicine/Product Recalls

View Recalls

SAHPRA Vigilance – Contact Details

To all stakeholders

 

Kindly note different email addresses that should be used for different vigilance submissions as stipulated below.

 

ADR reports in an e2b in an xml format e2b@sahpra.org.za
All other Adverse Drug Reaction (ADR) reports adr@sahpra.org.za
Pharmacovigilance related queries pvqueries@sahpra.org.za
Documentation relating to identified safety concerns, responses to PV recommendations, PSURs/PBRER, Risk Management Plans (RMPs) pvsubmissions@sahpra.org.za

 

 

 

 

 

 

 

 

 

Please refrain from sending one document to all email addresses as this creates duplication of reporting and misuse of resources.