Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
3. Advisory Committee on Chemicals Scheduling (ACCS #25) - Final decisions made pursuant to regulation 42ZCZR
3.2. Final decision in relation to sarolaner
Final decision
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to sarolaner as follows:
Schedule 6
SAROLANER except when included in Schedule 5.
Schedule 5 - Amend Entry
SAROLANER for veterinary use in divided preparations each the treatment, prevention and control of fleas and ticks in dogs in oral divided preparations each containing 120 mg or less of sarolaner per dosage unit.
Index
SAROLANER
Schedule 6
Schedule 5
Public submissions in response to the interim decision
No public submissions were received in response to the interim decision.
Reasons for the final decision (including findings on material questions of fact)
I have made a final decision to confirm my interim decision to amend the Schedule 5 entry for sarolaner to include veterinary use. I note that no public submissions were received before the second closing date in response to the call for further submissions published on 12 September 2019 under regulation 42ZCZP of the Regulations.
Date of effect of the decision
1 February 2020.