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

Vigilance Guidelines

Vigilance Forms

Vigilance Communication to Health Care Professionals

Vigilance Communication to the Public

Vigilance Newsletters

VigiGuardian Newsletters

Vigilance Manual

Vigilance Manual

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.