Public consultation on proposed amendments to the Poisons Standard (oral contraceptives) - ACMS, June 2021

Closed 27 May 2021

Opened 27 Apr 2021

Contact

Medicines Scheduling

1800 020 653

medicines.scheduling@health.gov.au

Feedback updated 15 Dec 2021

We asked

Public consultation was held between 27 April 2021 and 27 May 2021 on scheduling proposals referred to the June 2021 meeting of the Advisory Committee on Medicines Scheduling (ACMS) held on the 23 June 2021 and 24 June 2021.

You said

Respondents provided feedback on the proposed changes to the Poisons Standard regarding oral contraceptive substances. We received 27 submissions in response to the public consultation.

We did

The Delegate considered all submissions prior to making an interim decision on these proposals. The interim decision was published on 30 September 2021 on the TGA website.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

Scheduling amendments referred to expert advisory committee

This consultation is for applications to amend the Poisons Standard in relation to substances used in oral contraceptives. The scheduling proposals, and any submissions received, will be considered at the June 2021 meeting of the Advisory Committee on Medicines Scheduling (ACMS).

The closing date for this consultation is close of business 27 May 2021. All submissions received by the deadline will be considered by the delegate before they make an interim decision.

The proposals under consultation are detailed in the pre-meeting public notice in relation to substances used in oral contraceptives - ACMS, June 2021.

Proposals for which public comment is sought

  • Item 1.1 - Application A (3 substances, Items 2.1, 2.2 and 2.3 )
  • Item 1.2 - Application B (11 substances, Items 2.1 to 2.11)

Substances for which public comment is sought

  • Item 2.1 - ethinylestradiol
  • Item 2.2 - levonorgestrel
  • Item 2.3 - norethisterone
  • Item 2.4 - cyproterone
  • Item 2.5 - desogestrel
  • Item 2.6 - dienogest
  • Item 2.7 - drospirenone
  • Item 2.8 - estradiol
  • Item 2.9 - gestodene
  • Item 2.10 - mestranol
  • Item 2.11 - nomegestrol

What happens next

All public submissions will be published on the TGA website at Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission information (see Privacy and your Personal information).

Public submissions are an important part of the process for amending the Poison Standard, and are published on the TGA website using the consultation hub.  Submissions by the public may not reflect the views of the Department of Health or TGA.  Published submissions should not be taken as being endorsed by the Department or TGA.

Following consideration of public submissions received before the closing date and advice from the expert advisory committee/s, decisions on the proposed amendments are anticipated to be published as interim decisions on the TGA website: Scheduling delegate's interim decisions & invitations for further comment in September 2021.

Audiences

  • General public

Interests

  • Legislation