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Pharmacovigilance responsibilities of medicine sponsors

Australian recommendations and requirements

27 June 2018

Book pagination

Version history

Version history
Version Description of change Author Effective date
V1.0 New document Office of Product Review 10/11/2012
V1.1 Updated to include details of nominating/updating contact person for pharmacovigilance through eBS Help Desk Office of Product Review 13/12/2012
V1.2 Minor updates to the healthcare professional definition to remove coroner and overdose definition to remove final qualifying sentence. Office of Product Review 08/08/2013
V1.3 Minor updates to pharmacovigilance contact person text in Section 2.1 Office of Product Review 04/06/2014

New title

Revision to web-based format

New record-keeping requirements

New and updated information

Pharmacovigilance and Special Access Branch (PSAB) 01/09/2017
V2.1 Minor content update due to revised links to online adverse event reporting forms. Pharmacovigilance and Special Access Branch 27/06/2018

Book pagination