Final decisions amending, or not amending, the current Poisons Standard, August 2018

Proposed amendments to the Poisons Standard referred to expert advisory committee

Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed in circumstances including where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides to refer the proposed amendment to an expert advisory committee.

Under regulation 42ZCZK, these procedures require (among other things) the Secretary to publish (in a manner the Secretary considers appropriate) a notice specifying the expert advisory committee to which the proposed amendment will be referred, the date of the meeting of the committee and details of the proposed amendment.

Pursuant to regulation 42ZCZK, the Secretary must invite public submissions to be made to the expert advisory committee by a date mentioned in the notice as the closing date, allowing at least 20 business days after publication of the notice. Such a notice relating to the final decisions referred to herein was made available on the TGA website on 21 December 2017 and the opportunity to make submissions closed on 2 February 2018. Public submissions received on or before this closing date were published on the TGA website at Consultation: Proposed Amendments to the Poisons Standard – ACCS, ACMS and Joint ACCS-ACMS meetings, March 2018 in accordance with subregulation 42ZCZL(3).

Under regulation 42ZCZN of the Regulations, the Secretary, after considering the advice or recommendation of the expert advisory committee, must (subject to regulation 42ZCZO) make an interim decision in relation to the proposed amendment.

Under regulation 42ZCZP of the Regulations, the Secretary must, among other things, publish as soon as practicable (in a manner the Secretary considers appropriate) a notice setting out the interim decision and the reasons for making the interim decision and the proposed date of effect of the proposed amendment (if any).

Also, in accordance with regulation 42ZCZP of the Regulations, the Secretary must invite interested persons to make further submissions to the Secretary in relation to the interim decisions by a date mentioned in the notice as the closing date, allowing at least 10 business days after publication of the notice. Such a notice relating to the interim decisions of substances initially referred to the March 2018 meetings of the Advisory Committee on Medicines Scheduling (ACMS #23), the Advisory Committee on Chemicals Scheduling (ACCS #22), and the Joint Advisory Committee on Medicines and Chemicals Scheduling (ACMS #18) was made available on the TGA website on 7 June 2018 and closed on 5 July 2018 (Publication of interim decisions amending, or not amending, the current Poisons Standard, June 2018). Public submissions received on or before this closing date will be published on the TGA website (Public submissions on scheduling matters) in accordance with regulation 42ZCZQ.

Under regulation 42ZCZR of the Regulations, the Secretary may make a final decision by confirming, varying or setting aside the interim decision, but only after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a).

In deciding whether to amend the current Poisons Standard, the Secretary must take into account the matters mentioned in subsection 52E(1) of the Act. These matters include for example, the risks and benefits of the use of a substance, and the potential for abuse of a substance. The Secretary must also comply with (among others) any guidelines of the Australian Health Ministers’ Advisory Council referred to the Secretary for the purposes of section 52E of the Act including those set out in the Scheduling Policy Framework for Medicines and Chemicals.

Proposed amendments to the Poisons Standard not referred to expert advisory committee

Subdivision 3D.3 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides not to refer the proposed amendment to an expert advisory committee.

Publication of decisions pursuant to regulations 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990

In accordance with regulations 42ZCZS and 42ZCZX, this notice gives effect to the Secretary’s obligation to publish the final decisions, the reasons for those decisions and the date of effect of decisions made pursuant to regulations 42ZCZR, 42ZCZO, 42ZCZU or 42ZCZW of the Therapeutic Goods Regulations 1990.

The final decisions to which this notice relates include decisions made with respect to:

  • scheduling proposals initially referred to the March 2018 meeting of the Advisory Committee on Medicines Scheduling (ACMS #23);
  • scheduling proposals initially referred to the March 2018 meeting of the Joint meeting of the Advisory Committees on Chemicals and Medicines Scheduling (Joint ACCS-ACMS #18);
  • scheduling proposals initially referred to the March 2018 meeting of the Advisory Committee on Chemicals Scheduling (ACCS #22);
  • scheduling proposals on agricultural and veterinary chemicals, as well as new therapeutic Prescription Only medicines known as New Chemical Entities (NCEs) which were not referred to an expert advisory committee; and
  • AHMAC approved changes to Appendix J.
  • Privacy and your personal information

TGA, 23 August 2018 ; http://www.tga.gov.au/