1 Notice of interim decisions made under Regulation 42ZCZN of the Therapeutic Goods Regulations 1990
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 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 4 March 2021.
We have changed the way to make submissions.
Submissions should now be provided through our consultation hub. 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.
2 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #32, November 2020)
- 2.1 Interim decision in relation to amygdalin and hydrocyanic acid
- 2.2 Interim decision in relation to bilastine
- 2.3 Interim decision in relation to budesonide + formoterol
- 2.4 Interim decision in relation to psilocybin
- 2.5 Interim decision in relation to N, α-Dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA)
3 Interim decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #29, November 2020)
4 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #26, November 2020)
- 4.1 Interim decision in relation to azelaic acid
- 4.2 Interim decision in relation to 2-hydroxyethyl methacrylate (2-HEMA)
- 4.3 Interim decision in relation to magnesium hydroxide
- 4.4 Interim decision in relation to tetrahydrofurfuryl alcohol
- 4.5 Interim decision in relation to cannabidiol (private application)