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Permitted indications for listed medicines
The next version of the Therapeutic Goods (Permissible Indications) Determination will be published in February 2019.
The list of proposed changes to the Determination has been published for the information of sponsors at Upcoming changes to permissible indications 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).
Introduction of the permitted indications reform implements one of the Government's reforms to the regulatory framework for complementary medicines arising from the Medicines and Medical Devices Regulation Review (MMDR).
Changes to the Permissible Indication Determination February 2019
Since the introduction of the Determination in March 2018 stakeholders have contacted the TGA to seek clarification of indications and requirements. To address these issues, we are updating the Determination to correct a number of errors; improve clarity and accuracy of wording for sponsors and consumers; remove a number of appropriate indications; and add several new indications.
'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit, for example: 'relieves coughs'. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance).
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.
Introducing the list of permitted indications provides transparency on what indications are suitable for listed medicines to help prevent sponsor non-compliance and provides greater protection for consumers from misleading and inappropriate claims.
What medicines does it apply to?
The new permitted indications requirements apply to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens.
Medicines that are listed for export only and medicine kits are not affected by this change.
What has changed for listed medicine sponsors?
From commencement of the Permissible Indications Determination:
- There is no 'free-text field' for sponsors to enter their medicine indications when they apply to list their medicine in the ARTG using the Electronic Listing Facility.
- Sponsors who apply to list a new medicine will be required to select the indications for their medicine from the list of permitted indications.
- There is a 3 year transition period for sponsors of existing listed medicines to re-list their products using permitted indications.
- Sponsors can apply to have new indications considered for inclusion in the Permissible Indication Determination. The application form is available after logging in to your sponsor portal via the TGA Business Services website. An application fee applies.
For more information, please see the Permitted indications in listed medicines guidance.
How do I select permitted indications to list a medicine?
- All permitted indications and the requirements for their use by listed medicines are contained in the Permissible Indications Determination.
- Sponsors can access and search the list of permitted indications within the Listed Medicine Application form (please see the Listed medicine application and submission user guide) and on the TGA Business Services website.
- Regular updates will be made to the Determination when new indications are added or changes made to any indication requirements. This will occur quarterly unless no changes are required.
Key transition dates for sponsors
The transition plan has the following key 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. An application fee will 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.
Will I have to vary my existing medicine (s)?
Yes. All currently listed medicines will have to be updated so that they only include permitted indications within 3 years from the commencement of the reform.
Will there be an associated fee to change my indications over?
Sponsors who apply to update their existing listing to include permitted indications will not be charged an application fee during the first 18 months of the transition period. However, where other changes are made at the same time the applicable variation fee will apply.
|Type of change||Fee payable||New ARTG number issued||Must transition to permitted indications|
|New||Standard listing fee||Yes||Yes|
|Grouping (changes to indications only)||Nil||No||Yes|
|Variation||Standard variation fee only||No||No|
|Correction to ARTG record||Nil||No||No|
If you are planning to make a Grouping that is not related to your medicine indications (such as a change to your product name), you must apply to update your indications first (this will be free of charge within the first 18 months of the transition) and then do a separate grouping application to update your product name. If you do not do this, your application will validate as a 'New' and a new AUST L number will be generated for your product.
After the first 18 months of the transition period, the standard listing application fees will apply to change your indications.
Can I make other changes to my medicine within the transition period?
Yes, during the transition period, you can continue to make changes to existing listed products.
Any product that is the subject to a variation that amount to it being a 'separate and distinct' good under section 16(1A) of the Act must transition to permitted indications at the time of making the change. These include changes to:
- the active ingredient or quantity of active ingredient
- the dosage form
- the product name
These variations are described as 'New' and 'Group / Grouping' in the Guidance on product changes in ELF3. For changes made during the transition period, ELF will prompt you to remove your existing indications and enter permitted indications.
Other product changes (e.g. variations under section 9D of the Act) will not be required to transition to permitted indications at the time of the change. These variations are described as 'Vary / Variation' and 'Correction of ARTG Record' in the Guidance on product changes in ELF3.
If you have any issues accessing or using the Permissible Indication Determination or the search functions within with Listed Medicine Application form or TGA Business Services website, please contact Complementary Medicines via phone on 1800 020 653 or via email at firstname.lastname@example.org.