1 Final decisions made pursuant to regulation 42ZCZR - proposals referred to the November 209 Advisory Committee on Medicines Schedule (ACMS #28)
Note
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1.8. Final decision in relation to Lidocaine
Final decision
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to affirm the interim decision and amend the current Poisons Standard in relation to lidocaine as follows:
Schedule 2 - Amend Entry
LIDOCAINE in preparations for topical use other than eye drops:
- containing 10 per cent or less of total local anaesthetic substances, except:
i. in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
ii. in aqueous sprays for oromucosal use containing 0.6 per cent or less of total local anaesthetic substances; or
- in divided preparations containing 200 mg or less of total local anaesthetic substances, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.
Reasons for the final decision (including findings on material questions of fact)
I confirm the reasons for my final decision to amend the Poisons Standard in relation to the Schedule 2 entry for lidocaine are as detailed in my interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and have noted that no public submissions were received before the second closing date in response to the call for further submissions published on 6 February 2020 under regulation 42ZCZP of the Regulations.
Summary of public submissions on the interim decision
No public submissions were received in response to the interim decision.
Date of effect of the decision
1 June 2020