Since April 2009, the TGA has required Risk Management Plans be submitted for all:

• new chemical entities (i.e. a substance / product not currently entered in the ARTG)
• registered products when there is a major change in the way in which the product is used or if a new safety concern is identified with an existing product

For more details, go to: http://www.tga.gov.au/publication/risk-management-plans