This web publication constitutes a notice for the purposes of regulation 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations). In accordance with regulation 42ZCZX, this notice publishes:
the decision made by a delegate of the Secretary pursuant to regulation 42ZCZU;
the reasons for the final decision; and
the date of effect of the decision.
1 Final decision made pursuant to regulation 42ZCZU
1.1. Final decision in relation to risankizumab
Pursuant to regulation 42ZCZU of the Regulations, a Delegate of the Secretary has made a final decision to amend the current Poisons Standard in relation to risankizumab as follows:
Deleted text is shown as red, smaller font, with a strikethrough.
Appendix K - Delete Entry
Index - Amend Entry
Schedule 4 Appendix K
Reasons for the final decision (including findings on material questions of fact)
The proposed amendment was not referred to an expert advisory committee. In not referring this matter to the ACMS, I am satisfied that sufficient information has been provided by the Applicant for me to exercise my delegation.
In determining that this matter will be a delegate-only decision, I note that:
The Australian Product Information (PI) for risankizumab states "Risankizumab has no or negligible influence on the ability to drive and use machines".
The Applicant has stated that the PI for guselkumab, a similar interleukin-23 (IL-23) blocker, also describes that it has no or negligible influence on the ability to drive or use machines. It is not listed in Appendix K of the Poisons Standard and exhibits similar properties to risankizumab.
Risankizumab does not have the potential for sedation in humans in normal use and there is no animal or human data demonstrating impairment of critical motor flexes and cognitive skills applicable to driving or operating of machinery.
There is no need to warn users of the potential danger of the medicine when the user is in control of machinery or an automobile and there are no regulatory implications for the states and territories.
Therefore, based on the information provided in the application, it is considered that risankizumab does not require listing in Appendix K of the Poisons Standard.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.