Draft list of permitted indications - closed for comment

18 December 2017

The implementation of the Permitted Indications reform is dependent on the passage of the Therapeutic Goods Amendment (2017 Measures No. 1 Bill 2017) which proposes amendments to the Therapeutic Goods Act 1989 (Act). These proposed amendments have not yet been passed by Parliament.

More information on the Bill and implementation dates will be available in the first quarter of 2018.

1 November 2017

The first draft list of permitted indications was published on 5 July 2017, with a revised list published on 24 October 2017. The draft list of permitted indications closed for comment on 31 October 2017.

Between 5 July and 31 October 2017 stakeholders were provided with the opportunity to review and comment on the draft list of permitted indications prior to the permitted indications reform coming into effect.

Sponsors should not make regulatory decisions based on this preliminary information, as changes may occur before finalisation and implementation of the supporting legislation.

The TGA is currently reviewing stakeholder feedback and finalising the legislative instrument.

Files for download

How to access a pdf, Word, Excel, or CSV document

Draft list of permitted indications - CLOSED

Draft lists of evidence qualifiers - CLOSED

Permitted indications fact sheets

Background

In September 2016 the Government announced that the TGA will introduce a list of permitted indications that must be used by listed medicine sponsors to enter their product indications in the ARTG. The purpose of establishing the list of permitted indications is to:

  • Ensure that listed medicines can only make low level indications that are suitable for medicines that do not undergo pre market assessment.
  • Provide transparency for sponsors on what indications are suitable for listed medicines to help prevent inadvertent non-compliance.
  • Avoid consumers being misled by inappropriate indications on listed medicine labels.

More information about the implementation of the list of permitted indications is provided below and on our Frequently Asked Questions page.

The first draft list was published on 5 July 2017, with a revised list published on 24 October 2017.

The list closed for public comment on 31 October 2017.

What are permitted indications?

Please see our Frequently Asked Questions.

What is the list of permitted indications?

Please see our Frequently Asked Questions.

What do I do now?

The revised draft list of permitted indications is closed for public comment. Any further questions about the permitted indications reform can be emailed to complementary.medicine.reforms@health.gov.au.

What does this mean for sponsors?

From commencement of the permitted indications reform:

  • The 'free-text field' in the Electronic Listing Facility (ELF) will be removed.
  • Sponsors of all new medicines listed under section 26A of the Therapeutic Goods Act 1989 will be required to select their product indications from the list of permitted indications.
  • There will be a 3 year transition period for sponsors of existing listed medicines to re-list using permitted indications. This will include an 18 month 'fee-free' period for sponsors to transition existing listing products to ensure compliance with the new legislative requirements.
  • There will be a process for sponsors to apply for new indications to be added to the list of permitted indications. An application fee will apply once the reform has been implemented.

Key dates for sponsors

The proposed transition plan will involve the following key dates (subject to the necessary legislation being in place).

Date Description
July to 31 October 2017 Stakeholders were able to comment or propose new indications or evidence qualifiers. Application fees did not apply during this review period.
31 October to 15 December 2017 The TGA will review proposals for new indications and evidence qualifiers received by October 31 and finalise the legislative instrument. Proposals for new indications or evidence qualifiers will not be considered until the legislative instrument comes into effect.
TBA The permitted indications reform comes into effect. The transition period for existing listed products commences.
18 months from commencement The 'fee-free' period for sponsors to transition existing listed products ends. An application fee will apply to transitioning products in accordance with the TGA's Schedule of fees and charges.
3 years from commencement The transition period for existing listed medicines ends. All listed medicines must only contain permitted indications.

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