TGA: Submissions sought on Psilocybin and MDMA rescheduling for therapeutic use

[-RC-]

This consultation closes on 28 September 2020.

Contents

• 1 Proposed amendments referred for scheduling advice to ACMS #32
  • 1.1 Amygdalin and hydrocyanic acid
  • 1.2 Cannabidiol
  • 1.3 Bilastine
  • 1.4 Budesonide + formoterol
  • 1.5 Psilocybin
  • 1.6 N, α-Dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA)
• 2 Proposed amendments referred for scheduling advice to ACCS #29
  • 2.1 Azoxystrobin
  • 2.2 Triticonazole
• 3 Proposed amendments referred for scheduling advice to the Joint ACMS-ACCS #26
  • 3.1 Azelaic acid
  • 3.2 2-Hydroxyethyl methacrylate
  • 3.3 Magnesium hydroxide
  • 3.4 Tetrahydrofurfuryl alcohol (THFA)
• 4 Enquiries

How to respond

We have changed the way to make submissions.

Go to our consultation hub to make a submission about the proposals to amend the Poisons Standard.

If you have difficulty accessing the consultation hub or uploading your submission, contact [email protected] and include 'Proposed Amendments to the Poisons Standard (Medicines)' or 'Proposed Amendments to the Poisons Standard (Chemicals)' in the subject line of the email.

What will happen

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 coversheet (see Privacy information).

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 February 2021.

Privacy and your personal information

• Under the Therapeutic Goods Regulations 1990, for certain scheduling applications or proposals, the TGA is required to call for and publish any public submissions. These submissions may contain personal information of the individual making submissions and others. However, the TGA is not required to publish any confidential information including any personal information TGA collects from you.
• The TGA collects your personal information as part of its regulatory functions in this submission and may use your personal information in order to:
  • Contact you if the TGA wants to seek clarification of issues raised in your submission;
  • Check whether or not you consent to certain information that you have provided being made publicly available.
  • Help provide context about your submission (e.g. to determine whether you are a director of a company or representing an interest group where you consent to the publication of this information).
• The TGA will only disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site.
• Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE' and highlighted in grey.
• Please do not include personal information about other individuals in the body of your submission. The TGA will not publish submissions which contain information about other individuals. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
• Please note that the TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.

Enquiries

Any questions relating to submissions should be directed by email to [email protected] (for substances referred to the ACMS or Joint ACCS-ACMS) or [email protected] (for substances referred to the ACCS).