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 |
|---|---|---|---|---|---|
| Guideline for the handling of Dear Healthcare Professional ELECTRONIC SUBMISSION OF ADVERSE DRUG REACTION (ADR) REPORTS - E2B REPORTING | 2020 | 1 | Guideline | Download PDF | |
| Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety | 2020 | 5 | 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 |
DEAR HEALTH CARE PROFESSIONAL LETTERS
MEDICINE SAFETY ALERTS
| Doc# | Title | Version | SubVersion | Publish Date |
|---|---|---|---|---|
| DIPHENHYDRAMINE-CONTAINING MEDICINES | V1 | 20-Nov-2020 | ||
| 21.7 | Communication to industry on the sartans-containing medicines | V2 | 12-Oct-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.