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Pharmacovigilance responsibilities of medicine sponsors
Australian recommendations and requirements
27 June 2018
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 |
| V2.0 |
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 |