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Consultation: Proposed amendments to the Poisons Standard (oral contraceptives) - ACMS #34, June 2021

28 April 2021

We have changed the way to make submissions.

Submissions now should be provided through our consultation hub. Any submission about any of the proposals to amend the Poisons Standard will be considered at the next meeting of the Advisory Committee on Medicines Scheduling (ACMS).

This consultation closes on 27 May 2021.

Oral contraceptive proposals and substances referred to ACMS #34

Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard or decides to amend the Poisons Standard on his or her own initiative and decides to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZK, that the Secretary publish (in a manner the Secretary considers appropriate) the proposed amendment to be referred to an expert advisory committee, the committee to which the proposed amendment will be referred, and the date of the committee meeting. The Secretary must also invite public submissions to be made to the expert advisory committee by a date mentioned in the notice as the closing date, allowing at least 20 business days after publication of the notice.

In accordance with regulation 42ZCZK of the Regulations, the Secretary invites public submissions on scheduling proposals referred to the June 2021 meetings of the Advisory Committee on Medicines Scheduling (ACMS #34). Submissions must be received by close of business 27 May 2021.

Consultation documents

We aim to provide documents in an accessible format. If you're having problems using this document, please contact medicines.scheduling@health.gov.au (for substances referred to the ACMS or Joint ACCS-ACMS) or chemicals.scheduling@health.gov.au (for substances referred to the ACCS).

Contents

  • Oral contraceptive proposals and substances referred to ACMS #34
  • 1. Applications
    • 1.1 Application A: ethinylestradiol, levonorgestrel and norethisterone
    • 1.2 Application B: ethinylestradiol, levonorgestrel, norethisterone, cyproterone, desogestrel, dienogest, drospirenone, estradiol, gestodene, mestranol and nomegestrol
  • 2. Substances
    • 2.1 Ethinylestradiol
    • 2.2 Levonorgestrel
    • 2.3 Norethisterone
    • 2.4 Cyproterone
    • 2.5 Desogestrel
    • 2.6 Dienogest
    • 2.7 Drospirenone
    • 2.8 Estradiol
    • 2.9 Gestodene
    • 2.10 Mestranol
    • 2.11 Nomegestrol
  • 3. Additional requirements for pharmacy supply
    • 3.1 Appendix M entry proposed in Application A
    • 3.2 Appendix M entry proposed in Application B
  • 4 How to respond
  • 5 What will happen