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Public notice of final decisions - ACMS#29, ACCS#27, Joint ACMS-ACCS#24, March 2020

Scheduling medicines and poisons

24 August 2020

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3.2.1 Carbetamide

3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR

Note

New text is shown as green, larger font, with a horizontal line above it.

Deleted text is shown as red, smaller font, with a strikethrough.

3.2 Final decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #27, March 2020)

Final decision in relation to carbetamide

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 carbetamide as follows:

Schedule 6 - New Entry

CARBETAMIDE.

Appendix B - Delete Entry
Substance Date of entry Reason for listing Area of use
CARBETAMIDE Aug 1991 a 1

a = Low Toxicity

1 = Agriculture

INDEX - Amend Entry

CARBETAMIDE

Appendix B, Part 3

Schedule 6

Materials considered

In making this final decision, the Delegate considered the following material:

  • The application to amend the current Poisons Standard with respect to carbetamide;
  • The advice received from the Meeting of the Advisory Committee on Chemicals Scheduling (ACCS#27);
  • Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; and (c) the toxicity of a substance;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • The Scheduling handbook: Guidance for amending the Poisons Standard.
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 current Poisons Standard, to remove carbetamide from Appendix B and add it to Schedule 6. My reasons for making the final decision are those set out in the 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 10 June 2020 under regulation 42ZCZP of the Regulations.

Date of effect of the decision

1 October 2020

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