Draft list of permitted indications

5 July 2017

The draft list of permitted indications has been published to provide stakeholders with the opportunity to review, comment and propose new indications prior to the permitted indications reform coming into effect. Supporting materials have also been provided to assist stakeholders in understanding how the list will work and how the regulatory requirements for listed medicines will change.

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

Files for download

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

Draft list of permitted indications

Draft lists of evidence qualifiers

Permitted indications assessment tool (for new indications)

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.

Options for implementing this reform were proposed in the recent Consultation: Reforms to the regulatory framework for complementary medicines: Assessment pathways. This consultation has resulted in the preferred way to implement this reform as outlined below.

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

What do I do now?

Draft lists of permitted indications and evidence qualifiers will be available on our website until 31 October 2017. During this period, you can review and provide comments on the list and propose additional indications or evidence qualifiers prior to the lists being finalised.

We have developed a Permitted indication assessment tool to assist stakeholders to propose new indications. This tool is based on the agreed eligibility criteria for permitted indications, and outlines the matters that we will consider when making a decision to accept or refuse proposals for new indications. The tool can be used by stakeholders to self-assess whether an indication is suitable for inclusion in the list of permitted indications before making a request to the TGA.

Comments and proposals for new indications and new evidence qualifiers can be emailed to complementary.medicine.reforms@health.gov.au.

What are permitted indications?

Permitted indications are statements that will describe the therapeutic uses for listed medicines. When the permitted indications reform is implemented, sponsors will be required to use them to enter their product indications in the ARTG. Permitted indications will be assessed against a set of eligibility criteria to ensure that they are appropriate for low risk listed medicines that are not assessed pre-market. More information is provided in the Criteria for permitted indications fact sheet.

Permitted indications will have a consistent structure and terminology to describe the therapeutic uses that are appropriate for listed medicines as shown in shown in Diagram 1.

Diagram 1: Indication components

Action qualifier (e.g. 'Help') + Action (e.g. 'relieve') + Target qualifier (e.g. 'mild') + Target (e.g. 'itchy skin')

The 'core' mandatory components of permitted indications are an 'action' and 'target' for example: 'Relieves (action) itchy skin (target)'. In some cases, 'action qualifiers' and 'target qualifiers' may also be included in a permitted indication to ensure that the indication is low risk.

For some permitted indications, there will be 'requirements' (such as required label advisory statements) relating to their use in a listed medicine. The requirements will be used to help ensure that permitted indications are suitable for listed medicines that are not pre-market assessed. For more information see Are there any 'requirements' associated with the use of permitted indications?.

When entering their product indications in the ARTG, sponsors will also be able to select optional 'evidence qualifiers' (such as a healthy target population) to make a permitted indication more specific to align with the evidence that they hold for their medicine. For more information on evidence qualifiers see How can I make a permitted indication match the evidence I hold for my medicine?.

Draft list of permitted indications

The draft list of permitted indications contains a comprehensive list of 'core' indications that have been assessed against the agreed eligibility criteria and determined to be appropriate for low risk listed medicines that are not assessed pre-market.

To aid navigation, the draft list of permitted indications has been organised based on:

  • subcategories of the body system or body part to which the indications relate, for example: respiratory system, skin; and
  • the type of evidence that is required to support the use of the indication, such as: scientific evidence only; evidence of a tradition of use only; and general indications which can be supported by either scientific evidence or a tradition of use.

The draft permitted indications list contains proposed requirements relating to the use of indications in listed medicines.

We have also developed draft lists of evidence qualifiers for sponsors to add to their selected 'core' permitted indication.

Implementation of the permitted indications reform

From commencement of the permitted indications reform:

  • The 'free-text field' in the Electronic Listing Facility (ELF) will be removed, currently proposed for 1 January 2018.
  • 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.

Timeframes for implementation

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

Date Description
July 2017 The draft list of permitted indications will be published on the TGA website.
July to 31 October 2017 Stakeholders can comment or propose new indications or evidence qualifiers. Application fees will not apply during the review period.
31 October to 15 December 2017 The TGA will review proposals for new indications and evidence qualifiers and finalise the legislative instrument. Proposals for new indications or evidence qualifiers will not be considered until the legislative instrument comes into effect.
1 January 2018 The permitted indications reform comes into effect. The transition period for existing listed products commences.
30 June 2019 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.
1 January 2021 The transition period for existing listed medicines ends. All listed medicines must only contain permitted indications.

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