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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...

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...

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...