This circular provides the incoming timeframes for applications received by the Department of Health prior to the deadline on 9 May 2020, to list products on the November 2020 Prostheses List.
The Prostheses List: Guide to listing and setting benefits for prostheses advises that any outstanding information regarding inclusion of the product in the Australian Register of Therapeutic Goods (ARTG) should be submitted to the Department 4–5 weeks before the Prostheses List is published. Consistently with this advice, for the November 2020 Prostheses List, the deadline for submitting ARTG entries will be close of business 14 September 2020.
Sponsors should submit applications for duplication, deletion or transfer of sponsors at least 3 weeks in advance of an expected publishing day – that is, in order to be considered for inclusion in the November 2020 Prostheses List, sponsors should ensure the department receives their duplication, deletion or transfer of sponsors applications by no later than 25 September 2020.
We anticipate the 1 November 2020 Prostheses List being published no later than 2 weeks prior to its commencement.
Please note that no new, amendment, expansion, or compression applications for products from the General Miscellaneous Category in Part A of the Prostheses List are assessed at this point. Further information on General Miscellaneous Category applications is provided in the PHI 37/20 and the hibernation of the MTAA agreement questions and answers document.
Any queries in relation to the Prostheses List should be sent to prostheses@health.gov.au.