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The fee-free period for sponsors to transition existing listed medicines to permitted indications has been extended

26 September 2019

The TGA has extended the fee-free period for sponsors of existing listed medicines to transition to using permitted indications until 6 March 2021.

This decision has been made to minimise impacts on industry and help ensure continued market access for transitioning listed medicines.

Background

Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. The list of permitted indications is maintained by the TGA and provides a comprehensive list of indications currently accepted for listed medicines, provided appropriate evidence is held by the medicine sponsor.

The Permissible Indications Determination came into effect on 6 March 2018 with a three-year transition period for sponsors of existing listed medicines to re-list their products using permitted indications. The transition period ends on 6 March 2021. Listed medicines that have not transitioned to permitted indications will be automatically cancelled from the register on 7 March 2021.

For the first 18 months of the transition period, sponsors who applied to update their existing listing to include permitted indications were not be charged an application fee. The fee free period was scheduled to end 6 September 2019.

What has changed?

The fee-free period has been extended until 6 March 2021. Sponsors who apply to update their existing listing to include permitted indications during this period will not be invoiced the listing application fee. Applications will be processed as normal.

Where other changes are made at the same time the applicable variation fee may apply. For more information see Permitted indications for listed medicines.

Key transition dates
Date Description
6 March 2018 The permitted indications reform comes into effect. The transition period for existing listed products commences.
6 September 2019

The initial 'fee-free' period for sponsors to transition existing listed products ends.

Applications to transition existing products required to pay listing application fee in accordance with the TGA's Schedule of fees and charges.

25 September 2019

The 'fee-free' period for sponsors to transition existing listed products is extended.

The 'fee-free' period for sponsors to transition existing listed products is extended.

6 March 2021

The transition period for existing listed medicines ends. All listed medicines must only contain permitted indications.

ARTG entries that have not transitioned to Permitted Indications will be cancelled.

Further information

For more information about permitted indications for listed medicines and how to transition, please refer to 'Permitted indications for listed medicines guidance’.

If you have specific questions regarding permitted indications or the transition arrangements, please contact Complementary Medicines via phone on 1800 020 653 or via email at complementary.medicines@health.gov.au.