Public notice of interim decisions on proposed amendments to the Poisons Standard - ACMS#40, ACCS#35, Joint ACMS-ACCS#32 - November 2022

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 November 2022;
• 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 3 March 2023.

Please note that there are two consultations for the interim decisions. For submissions regarding the interim decision with respect to Paracetamol please see the link for the consultation hub below:

• Consultation hub for paracetamol

For submissions regarding substances other than paracetamol, please see the link for the other consultation hub below:

• Consultation hub for other substances

Submissions will be considered by the Delegate in making the final decision.

Please note that in accordance with subregulation 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

• 1 Notice of interim decisions to amend (or not amend) the current Poisons Standard
• 2 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #40, November 2022)
  • 2.1 Interim decision in relation to paracetamol
  • 2.2 Interim decision in relation to ivermectin
  • 2.3 Interim decision in relation to brimonidine
  • 2.4 Interim decision in relation to fexofenadine
  • 2.5 Interim decision in relation to ibuprofen
  • 2.6 Interim decision in relation to melatonin
• 3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #32, November 2022)
  • 3.1 Interim decision in relation to green tea extract
• 4 Interim decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #35, November 2022)
  • 4.1 Interim decision in relation to ethalfluralin
  • 4.2 Interim decision in relation to tigolaner