Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety

Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety

This document has been prepared to serve as a guideline to those who prepare and distribute Dear Healthcare Professional letters. It represents South African Health Products Regulatory Authority (SAHPRA) current thinking on the safety, quality and efficacy of medicines. It is not intended as an exclusive approach. SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine and may make amendments in keeping with the knowledge which is current at the time of consideration of safety data. Guidelines and application forms are available from the office of the Chief Executive Officer and SAHPRA website.

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Document Number: SAHPGL-CEM-PV-05
Version: 6
Date Updated: 25/08/2022
File Type: pdf
Category: Guideline
Unit: Pharmacovigilance