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 Number | File Name | Year | Version | Document Type | Download |
|---|---|---|---|---|---|
| Communication to industry on Post Marketing Reporting of ADRs guideline-May2021-v8.pdf | 2021 | 1 | Communication to Industry | Download PDF |
VIGILANCE GUIDELINES
| Document Number | File Name | Year | Version | Document Type | Download |
|---|---|---|---|---|---|
| ELECTRONIC SUBMISSION OF ADVERSE DRUG REACTION (ADR) REPORTS - E2B REPORTING | 2019 | 1 | Guideline | Download PDF | |
| 2.33 | Post-marketing reporting of adverse drug reactions to human medicines in South Africa | 2021 | 9 | Guideline | Download PDF |
| 2.63 | GUIDELINE FOR ADVERSE DRUG REACTIONS (ADRs) REPORTING FOR HEALTHCARE PROFESSIONALS | 2021 | 1 | Guideline | Download PDF |
| 6.28 | Valproate Annual Risk Acknowledgement Form | 2018 | 1 | Guideline | Download PDF |
| 9.08 | Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety | 2020 | 5 | Guideline | Download PDF |
VIGILANCE COMMUNICATION TO HEALTH CARE PROFESSIONALS
VIGILANCE COMMUNICATION TO THE PUBLIC
| Title | Version | SubVersion | Publish Date |
|---|---|---|---|
| A SIGNAL OF MYOCARDITIS / PERICARDITIS ASSOCIATED WITH PFIZER-BIONTECH’S COVID-19 VACCINE, COMIRNATY (BNT162B2) | V1 | 1.1 | 26-August-2021 |
| SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines | V1 | 1.1 | 20-August-2021 |
| SAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals | V1 | 1.1 | 22-April-2021 |
MEDICINE SAFETY ALERTS
| Doc# | Title | Version | SubVersion | Publish Date |
|---|---|---|---|---|
| A SIGNAL OF MYOCARDITIS / PERICARDITIS ASSOCIATED WITH PFIZER-BIONTECH’S COVID-19 VACCINE, COMIRNATY (BNT162B2) | V1 | 1.1 | 26-Aug-2021 | |
| DIPHENHYDRAMINE-CONTAINING MEDICINES | V1 | 20-Nov-2020 | ||
| 21.8 | Communication to industry on ranitidine-containing medicines | V1 | 12-Oct-2020 | |
| 21.9 | Communication to industry on metformin-containing medicines | V1 | 12-Oct-2020 | |
| 21.5 | MSA gamma benzine hexachloride | V1 | 04-Jun-2012 | |
| 21.6 | MSA cough and cold medicines | V1 | 04-Jun-2012 | |
| 21.4 | MSA atypical antipsychotics | V2 | 15-Jun-2009 | |
| 21.2 | MSA promethazine | V1 | 03-Sep-2007 | |
| 21.3 | MSA Rotarix | V1 | 03-Mar-2008 | |
| 21.1 | MSA ketoconazole and domperidone | V1 | 03-Jul-2006 |
SAHPRA VIGILANCE – CONTACT DETAILS
To all stakeholders
Kindly note different email addresses that should be used for different vigilance submissions as stipulated below.
For submission of:
- 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 create duplication of reporting and misuse of resources.