You are here

Risk management plans for medicines and biologicals

Australian requirements and recommendations

29 March 2019

Book pagination

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

October 2016

V3.1

Revised with biologicals content following consultation

Risk Management Plan Evaluation Section

November 2017

V3.2

Revised and circulated for targeted external consultation with new content re RMP compliance, generics, post-approval updates, new ASA, PSUR conditions

Risk Management Plan Evaluation Section

April 2018

V3.3

Revised following consultation

Risk Management Plan Evaluation Section

March 2019

Book pagination