Consultation: Therapeutic Goods (Excluded Goods) Determination 2018

The Therapeutic Goods Administration (TGA) has released a consultation paper: Clarification of the regulation of products used for and by people with disabilities - Options for amendment to the Therapeutic Goods (Excluded Goods) Determination 2018.

OTA will be making a submission to the consultation, and is seeking members' feedback to inform the submission.

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 the Therapeutic Goods (Excluded Goods) Determination 2018 consultation paper is to gather feedback on options for amending the Determination, 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.

The consultation paper is available here.

To provide your feedback to OTA on the consultation paper, please send this to amanda.jarasius@otaus.com.au by COB Friday 18 October 2019.