Risk management plans for medicines and biologicals

Book pagination

12 December 2017

Version history

Version Description of change Author Effective date
V1.0 Original Publication Risk Management Plans Section, Office of Product Review 03/09/2012
V1.1 Updated Template Risk Management Plans Section, Office of Product Review 05/09/2012
V1.2 Updated content Risk Management Plans Section, Office of Product Review 14/09/2012
V1.3 Updated content Risk Management Plans Section, Office of Product Review 03/10/2012
V2.0 Updated content, added Australian‐specific annex as attachment Risk Management Plan Evaluation Section, Post-market Surveillance Branch May 2015
V3.0 Published for consultation –updated content to include reference to biologicals Risk Management Plan Evaluation Section, Post-market Surveillance Branch October 2016
V3.1 Revised with biologicals content following consultation Risk Management Plan Evaluation Section, Pharmacovigilance and Special Access Branch November 2017

Book pagination