Source: Australian Department of Health – Therapeutic Goods Administration
Scheduling medicines and poisons
Interim decisions have not been made for atranol and chlororatranol and for solvent yellow 33. The delegate is seeking further advice on how to most appropriately schedule skin sensitisers.
Publication of interim decisions made pursuant to regulation 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations)
In accordance with regulation 42ZCZP of the Regulations, this notice gives effect to the Secretary’s obligation to publish the interim decisions, the reasons for those decisions and the proposed date of effect of decisions made pursuant to regulation 42ZCZN.
The interim decisions to which this notice relates include decisions made in respect to:
- proposed amendments referred to the November 2018 meeting of the Advisory Committee on Medicines Scheduling (ACMS #25);
- proposed amendments referred to the November 2018 meeting of the Joint meeting of the Advisory Committees on Chemicals and Medicines Scheduling (Joint ACCS-ACMS #20); and
- proposed amendments referred to the November 2018 meeting of the Advisory Committee on Chemicals Scheduling (ACCS #23).
Call for further submissions
In accordance with regulation 42ZCZP of the Regulations, this notice invites interested persons to make submissions to the Secretary in relation to the interim decisions on or before the close of business on 7 March 2019 (second closing date). See How to respond below.
How to respond
Your submission should:
- be relevant to the proposed amendment/s, including whether or not you support the amendment/s;
- address matters mentioned in section 52E of the Therapeutic Goods Act 1989;
- be submitted by the second closing date to firstname.lastname@example.org for substances referred to the ACMS or Joint ACMS-ACCS, or email@example.com for substances referred to the ACCS. (Please include ‘Proposed Amendments to the Poisons Standard (Medicines/Chemicals)’ in the subject line of the email);
- ideally be no more than 3 pages; and
- be accompanied by a completed TGA Consultation submission coversheet.
Submissions might also include:
- Suggested improvements to the proposed amendments; and/or
- An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.
Publication of submissions received on or before the second closing date
Pursuant to regulation 42ZCZQ(4) and (5), the Secretary will publish all public submissions received on or before the second closing date on the TGA’s webpage titled: Public submissions on scheduling matters.
The Secretary will not, however, publish any information that the Secretary considers to be confidential information.
Accordingly, in order to assist the Secretary to make this assessment, please:
Further information about how TGA considers information which might be personal or sensitive in nature is set out below in the section titled Privacy and your personal information.
What will happen next
After considering all relevant submissions received on or before the second closing date (and or obtaining any further advice), the Secretary may make final decisions confirming, varying or setting aside the interim decisions. Final decisions will be published on the TGA’s webpage titled Scheduling delegates’ final decisions on 26 April 2019.
Privacy and your personal information
The Therapeutic Goods Administration (TGA) collects your personal information in this submission in order to:
- Contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether 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 an individual or a director of a company or representing an interest group).
The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if, when making your submission, you consent to the publication of your name on the TGA Internet site. If at any point in time, you change your mind and wish for your personal information to be redacted then please contact the Scheduling Secretariat at firstname.lastname@example.org so that the pubic submissions can be updated accordingly.
The TGA will not publish information it considers confidential, including yours/other individuals’ personal information (unless you/they have consented to publication or it is required by law) or commercially sensitive information. Also, the TGA will not publish information that could be considered advertising or marketing (e.g. logos or slogans associated with products), information about any alleged unlawful activity or that may be defamatory or offensive.
Please do not include personal information about other individuals in the body of your submission. 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.
Any questions relating to submissions should be directed by email to email@example.com (for substances referred to the ACMS or Joint ACCS-ACMS) or firstname.lastname@example.org (for substances referred to the ACCS).
- Advisory Committee on Medicines Scheduling (ACMS #25)
- Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS/ACMS #20)
- Advisory Committee on Chemicals Scheduling (ACCS #23)