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
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
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
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
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.
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This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 .
The exemption applies to medical devices that are clinical...More
From 25 February 2021, a new framework for regulating personalised medical devices will commence. Comprehensive guidance about the framework can be found at: https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices
The Therapeutic Goods...More
From 19 October 2020, how the TGA engages with the sponsors for post market reviews has changed. A new medical device Post Market Review Compliance Dashboard has been developed in TBS to respond to post market reviews. The new compliance dashboard will provide the sponsors with an efficient...More
Thank you for your interest in becoming accredited as a service provider for the Australian Government Hearing Services Program.
Please click the link below to begin your application.
You may wish to download a PDF of the application form for your information before you proceed....More
The Australian Government is undertaking a significant program to reform 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 the...More
This form should be used by manufacturers and sponsors of medical devices that record patient images or that are anatomical models, and that will be reclassified by the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for...More
This form should be used by manufacturers and sponsors of medical devices that are eligible for the transition period for custom-made medical devices that will be patient-matched medical devices from 25 February 2021. Devices are eligible for transition if:
the device has been supplied...More
Thank you for your interest in transferring your accreditation as a service provider for the Australian Government Hearing Services Program to another entity.
Please click the link below to begin your application.
You may wish to download a PDF of the application form for your...More
Thank you for your interest in becoming registered as an Appointed Supplier for the Australian Government Hearing Services Program.
Please click the link below to begin your application.
You may wish to download a PDF version of the application form before you proceed. Note that we...More
The Australian Government has a clear and bold vision for sport integrity in Australia, and is committed to ensuring Australian sport is appropriately protected in the rapidly evolving sports integrity threat environment .
The reforms announced as part of this package will require...More