Effective March 8th 2018 Permitted indications are now available through eBS for listed medicines.
The TGA has implemented a list of permitted indications for medicines listed under Section 26A of the Therapeutic Goods Act 1989 (the Act).
The list of permitted indications can be accessed via the Therapeutic Goods (Permissible Indications) Determination.
The list of permitted indications implements one of the Government’s reforms to the regulatory framework for complementary medicines arising from the Medicines and Medical Devices Regulation Review (MMDR). The reforms aim to provide better transparency on what indications are suitable for listed medicines to help prevent sponsor non-compliance and also provides greater protection for consumers from misleading and inappropriate claims.
Effective from 6 March 2018:
- There is no ‘free-text field’ for sponsors to enter their medicine indications in eBS.
- Sponsors who apply to list a new medicine will be required to select the indications for their medicine from the list of permitted indications. Permitted indications must still comply with the requirements for evidence for listed medicines.
- There is a 3 year transition period (ending 6 March 2021) for sponsors of existing listed medicines to amend their listings using permitted indications.
- Effective 6th March there is an 18 month fee-free period where sponsors can amend their listings to permitted indications without incurring TGA fees. After the grace period there will be a charge of $800 per listing to amend indications.
- Sponsors can apply to have new indications considered for inclusion in the Permissible Indication Determination. An application fee is applicable.
|Key transition dates|
|6 March 2018||The permitted indications reform comes into effect. The transition period for existing listed products commences.|
|6 September 2019||The ‘fee-free’ period for sponsors to transition existing listed products ends.|
|6 September 2019 – 6 March 2021||Application fee’s apply to transitioning products in accordance with the TGA’s Schedule of fees and charges.|
|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.|
For more information relating to the Permissible Indications Determination please see the TGA website and Permitted indication for listed medicine guidance or contact our office at firstname.lastname@example.org or call 02 6686 6797.