Australian guideline for pharmacovigilance responsibilities of sponsors of registered medicines regulated by Drug Safety and Evaluation Branch
Australian pharmacovigilance guideline
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 was published in the Commowealth of Australia Gazette, No. GN 25, 29 June 2005.
31 May 2005
The Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by Drug Safety and Evaluation Branch (July 2003) has been amended to reflect changes that have occurred to EU pharmacovigilance reporting documentation.
The guideline continues to be based on sections 1.1 to 1.3 of Volume 9 - Pharmacovigilance Rules Governing Medicinal Products in the European Union, published by the European Commission, Directorate Enterprise, Regulatory Framework and Market Authorisations (Version December 2001). Elements from the ICH document CPMP/ICH/3945/03 Note for Guidance on definitions and standards for expedited reporting have been included in an Annex to the guideline. Current Australian reporting requirements are unchanged.
Contents
- 1. Legal basis and purpose
- 2. Adverse reaction reporting
- 3. Reporting requirements in special situations
- Annex 1 Definitions and standards for reporting
- Annex 2 Recommended key data elements for inclusion in expedited reports of serious adverse drug reactions
- Annex 3 Addresses for reporting