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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1.7. Final decision in relation to Hyoscine butylbromide
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 hyoscine butylbromide as follows:
Schedule 4 - New Entry
HYOSCINE BUTYLBROMIDE except when included in Schedule 2 or 3.
Schedule 3 - New Entry
HYOSCINE BUTYLBROMIDE in undivided preparations for oral use with a recommended single dose not exceeding 20 mg of hyoscine butylbromide in a pack containing 100 mg or less of hyoscine butylbromide when labelled for adults and children 6 years and over.
Schedule 2
HYOSCINE BUTYLBROMIDE as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.
Schedule 2 - Amend Entry
HYOSCINE (excluding hyoscine butylbromide):
- for transdermal use in preparations containing 2 mg or less of total solanaceous alkaloids per dosage unit; or
- for oral use:
- in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
- in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
Appendix H - New Entry
HYOSCINE BUTYLBROMIDE
Index - Amend Entry
HYOSCINE BUTYLBROMIDE
Schedule 4
Schedule 3
Schedule 2
Appendix H
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 hyoscine butylbromide by creating new Schedule 3, Schedule 4 and Appendix H entries and removing the reference to hyoscine butylbromide in the Schedule 2 entry for hyoscine, 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