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Notice of interim decisions on proposed amendments to the Poisons Standard – ACMS #47 and Joint ACMS-ACCS #40 – June 2025

Published

This web publication constitutes a notice for the purposes of regulation 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations). In accordance with regulation 42ZCZP, this notice sets out:

  • the interim decisions made by a delegate of the Secretary under regulation 42ZCZN in relation to proposed amendments to the current Poisons Standard which were referred to an expert advisory committee under subdivision 3D.2 of the Regulations in June 2025
  • the proposed date of effect of the proposed amendments (in circumstances where the interim decision proposes an amendment to the current Poisons Standard).

In accordance with regulation 42ZCZP, interested persons (including the applicant requesting the amendment) are invited to make submissions to the Secretary in relation to these interim decisions on or before 10 July 2026.

Submissions should be provided through our consultation hub. Submissions will be considered by the Delegate in making the final decision.

Please note that in accordance with sub regulation 42ZCZQ (4) of the Regulations, the Secretary must publish all relevant submissions received, unless the Secretary considers the information to be confidential information.

If you have difficulty accessing the consultation hub or uploading your submission, contact medicines.scheduling@health.gov.au and include 'Proposed Amendments to the Poisons Standard (Medicines)' or 'Proposed Amendments to the Poisons Standard (Chemicals)' in the subject line of the email.

Interim decision

We aim to provide documents in an accessible format. If you're having problems using this document, please contact medicines.scheduling@health.gov.au.

Contents

  • Notice of interim decisions
  • Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #47, June 2025)
    • Somatrogon, lonapegsomatropin and somapacitan
    • 6-Methylnicotine
  • Interim decisions on proposed amendments referred to the Advisory Committees on Medicines and Chemicals Scheduling in joint session (ACMS-ACCS #40, June 2025)
    • Azelaic acid
    • Extracts and essential oils primarily composed of methyl salicylate
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