Publication of interim decisions proposing to amend, or not amend, the current Poisons Standard, September 2018

Scheduling medicines and poisons

10 September 2018

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This consultation closes on 11 October 2018

Publication of interim decisions made pursuant to regulations 42ZCZN of the Therapeutic Goods Regulations 1990

In accordance with regulation 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations), this notice gives effect to the Secretary's obligation to publish 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 June 2018 meeting of the Advisory Committee on Medicines Scheduling (ACMS #24); and
  • proposed amendments referred to the June 2018 meeting of the Joint meeting of the Advisory Committees on Chemicals and Medicines Scheduling (Joint ACCS-ACMS #19).

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 11 October 2018 (second closing date).

See How to respond below.

How to respond

Your submission should:

  • be relevant to the proposed amendment, 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 medicines.scheduling@health.gov.au for substances referred to the ACMS or Joint ACMS-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 amendment; 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 web page 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 web page titled Scheduling delegates' final decisions on 29 November 2018.

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 medicines.scheduling@health.gov.au 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.

For general privacy information, please go to the TGA's webpage on Privacy. The TGA is part of the Department of Health and the link includes a link to the Department's privacy policy and contact information if you have a query or concerns about a privacy matter.

Enquiries

Any questions relating to submissions should be directed by email to medicines.scheduling@health.gov.au (for substances referred to the ACMS or Joint ACCS-ACMS) or chemicals.scheduling@health.gov.au (for substances referred to the ACCS).

Contents

  1. Advisory Committee on Medicines Scheduling (ACMS #24)
  2. Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #19)

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