Listed Medicine Reforms – Permitted Indications and Application Fees

Permitted Indications

The closing date for proposing additional indications or evidence qualifiers to the TGA to be considered for the core list of permitted indications, is 31 October 2017. After this date, the list will be finalised and if sponsors wish to apply for new indications to be added to the list an application fee will apply. The proposed application fee for the inclusion of a new permitted indication is $1,020.

Please be aware that once the reforms take place sponsors will be required to use only permitted indications to enter their product indications on the ARTG. There will be no option when listing a product for free text. Sponsors will still be required, when applying to list their medicines in the Register, to certify that they hold suitable evidence to support their indications and it will be grounds for cancellation from the Register if such a certification was, or is no longer, correct.

We strongly encourage sponsors to make sure that they have read through the proposed list of indications and qualifiers to ensure that the claims that they are currently making (or words to that effect) in relation to their products are covered. You can find more information pertaining to the permitted indication reforms and view the draft list of permitted indications and the draft list of evidence qualifiers at the TGA Website.

If you do have indications or qualifiers that you would like considered for addition to the core list of permitted indications you can send them to the TGA by emailing complementary.medicine.reforms@health.gov.au. Alternatively, if you would like to AWRS to lodge indications on your behalf please email the indications with the following subject heading “Proposal for new indications and evidence qualifiers” to info@regsolutions.com.au by no later than Friday 20^th October 2017.

Time frames for Implementation:

July 31 – 31 October 2017	Opportunity to propose indications to the core list of permitted indications.
15 December 2017	Legislative Instrument finalised
1 January 2018	Permitted indications reform comes into effect and 3-year transition period commences.
1 January 2018 – 30 June 2019	Fee-free transition period for updating indications for existing listed medicine products.
30 June 2019 – 1 January 2021	Transition period continues for updating indications for existing listed medicine products however application fee will apply in accordance with the TGA’s schedule of fees and charges at that time.
1 January 2021	Transition period for existing listed medicine products ends. Any products on the ARTG that have not been updated with permitted indications by this date will be cancelled from the ARTG.