Consultations

This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the scheduling in the Poisons Standard, following advice sought at the 23-25 June 2020 meetings of the Advisory Committee on Medicines Scheduling (ACMS), and the Advisory Committee on Chemicals Scheduling (ACCS).

Consultation: Permissible ingredients annual changes 2020-21

The Secretary invites public submissions on scheduling proposals. Closing date: 28 September 2020

The Therapeutic Goods Administration (TGA) is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain.

Draft IMDRF document. Closing date: 26 May 2020

The Secretary invites public submissions on scheduling proposals referred to the June 2020 meeting of the Joint ACMS-ACCS. Closing date: 22 May 2020

Consultation extension. Closing date: 18 May 2020

The TGA is seeking feedback for the Scope Regulated Software based products. Closing date: 13 May 2020

Draft IMDRF document. Closing date: 9 May 2020

The Secretary invites public submissions on scheduling proposals referred to the March 2020 meetings of the ACMS, the ACCS, and the Joint ACMS-ACCS. Closing date: 10 February 2020

The Secretary invites public submissions on scheduling proposals referred to the March 2020 meeting of the Joint ACMS-ACCS. Closing date: 10 February 2020

Consultation on proposed adoption or non-adoption of EU and ICH guidelines. Closing date: 7 Feb 2020

The TGA is seeking comments from interested parties on an update to guidance for the Export of therapeutic goods from Australia.

TGA is seeking comment from interested parties on proposed standards for faecal microbiota transplant (FMT) products in Australia. This is a new area of regulation for TGA from 2020.

The closing date of this consultation has been extended. Closing date: 6 December 2019

The final date for public submissions to the consultation has been extended to 31 October 2019

TGA is seeking comments on clarification of the regulation of products used for and by people with disabilities. Closes: 25 October 2019

The Secretary invites public submissions on the scheduling proposals referred to the November 2019 meetings of the ACMS and joint ACCS/ACMS. Closing date: 17 October 2019

The TGA is seeking comments on the proposed changes to the Essential Principles for safety and performance of medical devices. Closing date: 17 October 2019.

These proposed ingredient changes have been reviewed and categorised as being of low-negligible risk. Closing date: 11 October 2019

We are seeking feedback on a proposal to publish the names of excipient ingredients used in therapeutic goods in the public view of the Australian Register for Therapeutic Goods (ARTG).

Draft IMDRF document. Closing date: 3 October 2019

The Secretary invites public submissions on the scheduling proposals referred to the November 2019 meetings of the ACMS and ACCS. Closing date: 26 September 2019

The TGA sought comments from interested parties on the making of an order under subsection 7(1) of the Therapeutic Goods Act 1989. Closing date 18 September 2019

The TGA invites interested parties to comment on the IMDRF consultation document. Closing date: 24 July 2019