The Australian Government endorsed a significant program of reform to further strengthen the regulation of medicines and medical devices in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates these products, and is responsible for implementing the Government's reforms.
The focus of this paper is to obtain feedback on options for amending the Therapeutic Goods (Excluded Goods) Determination 2018, to clarify which products intended for use for, or by, people with disabilities are excluded goods, and so regulated as consumer rather than therapeutic goods.
All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website. Once finalised, the regulatory changes and implementation arrangements will be published on the TGA website.
The 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).
seek feedback about how the consultation was undertaken.
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.
More information on consultations and privacy is included in the submission form and on our website.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.