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30 Sep

Posted at 11:00h in

This manual is guided by the policies of the NDoH and SAHPRA, with recommendations from the World Health Organization (WHO), to serve as guidelines for vaccine safety surveillance. It provides guidelines and procedures to healthcare professionals at all levels within the healthcare sector in South Africa in the...

30 Sep

Posted at 10:55h in

The SAHPRA Pharmacovigilance Reference Manual for Healthcare Professionals in South Africa, used in tandem with the Training Manual for Healthcare Professionals on Pharmacovigilance in South Africa, will facilitate the early detection of health product-related adverse reactions and enable the identification of previously unknown adverse drug...

30 Sep

Posted at 10:53h in

SAHPRA has developed this manual to facilitate training of HCPs in pharmacovigilance. We hope that this training manual will effectively prepare the facilitators to train other HCPs in the science of pharmacovigilance....

01 Apr

Posted at 14:01h in

The South African Health Products Regulatory Authority (SAHPRA) launched the Online Medicines Directory for over-the-counter (OTC) medicines in June 2022. The platform, available at www.medsinfo.sahpra.org.za, serves as a single, trusted source of information for patients, consumers, and healthcare professionals on all medicines approved by SAHPRA. Phase...

09 Oct

Posted at 10:55h in

This manual focuses on surveillance and response to Adverse Events Following Immunisation. It is guided by the policies of the National Department of Health and the South African Health Products Regulatory Authority, with recommendations from the World Health Organisation, to serve as guidelines for Vaccine Safety Surveillance. It provides guidelines and procedures for healthcare professionals at...

03 Oct

Posted at 10:47h in

SAHPRA has launched an Online Medicines Directory. Please visit: www.medsinfo.sahpra.org.za   The Online Medicines Directory has been launched for Schedule 0-2. The job is to increase awareness and use of the directory amongst consumers, patients and healthcare providers. This toolkit provides Market Authorisation Holders (MAH) and SAHPRA...

20 Sep

Posted at 10:10h in

This guide is intended to provide guidance to applicants on Good Review Practices. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. It is not intended...