The Therapeutic Goods Administration (TGA) is seeking feedback on options to improve the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The Code is the compliance standard that prescribes the minimum requirements for the lawful advertising of therapeutic goods to the general...More
Scheduling amendments referred to expert advisory committee
This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the June 2021 meeting of the ...More
Health services funded under the Indigenous Australians’ Health Programme (IAHP) collect and supply important Indigenous health data sets to the Department of Health as part of their funding agreements. These are the:
Aboriginal and Torres Strait Islander National Key Performance...More
Scheduling amendments referred to expert advisory committee
This consultation is for applications to amend the Poisons Standard in relation to substances used in oral contraceptives. The scheduling proposals, and any submissions received, will be considered at the June 2021...More
CONTENT WARNING
The Department of Health acknowledges the devastating effects associated with acts of self-harm on individuals, their families, friends and communities. This consultation relates to information on self-poisonings that some people may find distressing. If you, or someone you...More
Scheduling amendments referred to expert advisory committee
This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the June 2021 meeting of the ...More
Scheduling amendments referred to expert advisory committee
This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the June 2021 joint meeting of the ...More
Introduction
The Australian Health and Food Collaboration’s review of fast food menu labelling highlighted concerns with the current menu labelling regulation in Australia:
nationally inconsistent menu labelling legislation;
an uneven...More
Introduction
In November 2019 the Australia and New Zealand Ministerial Forum on Food Regulation endorsed an ambitious plan to reform the Bi-national Food Regulation System to ensure it remains strong, robust and agile into the future. A...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing methyl salicylate for dermal use , for inclusion in the Required...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on addition of a proposed new required advisory statement for labels of non-prescription medicines containing more than 1.5 per cent lidocaine (lignocaine) for topical oral use, for inclusion in the ...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on changes to current requirements for advisory statements for labels of non-prescription medicines containing antihistamines indicated for short term use in insomnia (diphenhydramine, doxylamine and...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on the addition of proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing menthol for dermal use, for inclusion in the Required...More
The Therapeutic Goods Administration (TGA) is seeking feedback on proposals to help ensure ongoing, reliable supply of important medicines.
Medicine shortages have been of particular concern during the COVID-19 pandemic. We have been reviewing the ways in which we can better assist...More
The Australian Government, through the Critical Technologies Policy Coordination Office (CTPCO), is undertaking consultation on the future of critical technologies in the Australian agriculture and health sectors. Critical technologies are current and emerging technologies...More
Preventive health is a key pillar of Australia’s Long Term National Health Plan with mental health.
In June 2019, the Minister for Health, the Hon Greg Hunt MP announced that the Australian Government would develop a 10-year National Preventive Health Strategy (the...More
The Department of Health is introducing a number of changes to the Aged Care Financial Report (ACFR) commencing with the submission of the 2020-21 ACFR.
Major changes include:
detailed residential segment income and expense statement at the facility level
enhanced approved...More
This consultation is to obtain feedback in relation to proposals to provide clarity on residual claims for disinfectants.
The Therapeutic Goods Administration (TGA) has received a number of enquiries relating to residual activity claims for disinfectants, including whether...More
This form is to completed if you wish to complete a request for a revalidated service for a client with the Australian Government Hearing Services Program.
Please click the link below to begin your request.
DISCLAIMER
This is a draft form for testing purposes only. The form...More
The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing...More
The Therapeutic Goods Administration (TGA) is seeking comments on a proposed standard for vaporiser nicotine products.
Vaporiser nicotine products are nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine...More
The Australian Government Department of Health invites you to share your views on the proposed approach to making mitochondrial donation available in Australia. The Australian Government wants to introduce mitochondrial donation so this lifesaving technology is made available for families impacted...More
From 25 February 2021, a new framework for regulating software as a medical device will commence. The Regulation of software based medical devices details these changes, and additionally the following guidance documents have also been published to assist users understand the various...More
The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on options for the TGA’s proposed fees and charges for the 2021-22 financial year. Specifically, we are seeking feedback on the...More
Repurposing is the process of identifying new uses (or ‘indications’) for medicines. In some cases, prescription medicines may have been used ‘off-label’ for many years to treat conditions that they do not have formal regulatory approval (i.e. are not registered) for. Whilst this may...More
This form should be used by sponsors and manufacturers of software-based medical devices that will need to be included in the ARTG at a higher classification as a result of the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for...More
Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 4-5 November 2020 meetings of the Advisory Committee on...More
The Department of Health administers the Australian Government Hearing Services Program (the program). The program supports the delivery of hearing services to over one million eligible clients through Contracted Service Providers.
More
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to streamline how information about certain therapeutic goods formulations is entered into TGA electronic systems when seeking market approval.
Specifically, we propose to discontinue entering certain types...More