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The PSAB assesses causality of adverse event(s) and in some cases requests further clinical or laboratory information from the reporter.Medical officers review serious reports and branch staff regularly analyse reporting data to identify potential safety signals.
Sponsors of all medicines and vaccines on the ARTG have mandatory reporting requirements regarding adverse events.
The functions of ACSOM were consolidated into the Advisory Committee for Medicines on 1 January 2017.
Following a recommendation from the government's Review of the management of adverse events associated with Panvax and Fluvax in 2012 'to consider the current governance arrangements for monitoring and responding to vaccine safety issues in Australia and make recommendations for an improved system of governance for vaccine safety monitoring', the Advisory Committee on the Safety of Vaccines (ACSOV) was established in the Therapeutic Goods Regulations.
The functions of ACSOV are to provide advice and make recommendations to the Minister for Health, the TGA and the Office of Health Protection on the safety, risk assessment and risk management of vaccines.
ACSOV meeting statements are published on the TGA website.
RMPs accompany applications for registration of high risk medicines, such as new chemical entities.
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