Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by Drug Safety and Evaluation Branch (July 2003 – Amended 31 May 2005)
(2005; 22 pages)

Abstract

This guideline is specifically for the reporting of adverse reactions to registered medicines regulated by the Drug Safety and Evaluation Branch (DSEB) of the TGA. It replaces the advice contained within Appendix 20 of the Australian Guidelines for the Registration of Drugs on reporting requirements for DSEB-registered medicines. Throughout the document the terms "product" and "registered medicinal product" are used to mean registered medicines regulated by DSEB.

 
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