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This consultation closed on 9 July 2020.
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 March 2020;
- 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 9 July 2020.
Persons making submissions are strongly encouraged to lodge submissions in an electronic format (word or unsecured PDF preferred) using the public submission coversheet available on the TGA's website. Where possible, submissions should be sent to one of the email addresses provided below:
- chemicals.scheduling@health.gov.au (for submissions relating to interim decisions made in relation to proposed amendments referred to the Advisory Committee on Chemicals Scheduling); or
- medicines.scheduling@health.gov.au (for submissions relating to interim decisions made in relation to proposed amendments referred to the Advisory Committee on Medicines Scheduling or the Advisory Committee on Medicines and Chemicals Scheduling in joint session).
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.
Contents
- 1 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #29 March 2020)
- 1.1. Interim decision in relation to rizatriptan
- 1.2. Interim decision in relation to ondansetron
- 1.3. Interim decision in relation to melatonin
- 1.4. Interim decision in relation to adapalene
- 1.5. Interim decision in relation to Selective Serotonin Reuptake Inhibitors (SSRI)
- 1.6. Interim decision in relation to ranitidine
- 1.7. Interim decision in relation to fexofenadine
- 1.8. Interim decision in relation to flurbiprofen
- 2 Interim decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #27, March 2020)
- 3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #24, March 2020)