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Dec-2018-Permissible-Indications.pdf (6 MB)

‘Indications’ are statements that refer to the therapeutic use of a medicine and it’s claimed benefits. They are categorised into the following types:

  • Specific indications: Refer to a non-serious condition
  • Non-specific indications: Refer to general health maintenance

On 6th March 2018, the Therapeutic Goods Administration (TGA) introduced a list of permitted indications for listed medicines, removing the ‘free-text field’ in the Electronic Listing Facility.
Consequently, sponsors are no longer able to add their own indications in their own wording and must select indications for their medicine from a pre-determined list.

The Therapeutic Goods (Permissible Indications) Determination No.1 of 2018 contains the list of indications from which a sponsor must select the most appropriate indication for their medicine.

It is important that sponsors hold the appropriate evidence, Scientific or Traditional, for their selected indications before listing the product.

The indication tables also mention the type of evidence required to support each indication as well as Other requirements, such as associated label statements.

For example, the indication ‘Anti-inflammatory/relieve inflammation’ can be supported by either Scientific or Traditional evidence and the label statement ‘If symptoms persist, seek the advice of
a healthcare professional’ must be included in the product labelling.

Benefits of the new permitted indications list include:

  •  Transparency on suitable indications for low risk listed medicine
  •  Prevent sponsor non-compliance
  • Protects consumers from misleading and inappropriate claims.

Transition period

Sponsors will be able to update their existing listings to include permitted indications free of charge up until 6 September 2019. After this date, an application fee will apply to listing variations
as per the TGA’s Schedule of fees and charges.

By 6 March 2021 all listed medicines must have completely transitioned to the new system and only contain permitted indications. Those listed medicines which have not transitioned, will be cancelled from the ARTG.

For further information, please visit: https://www.tga.gov.au/permitted-indications-listed-medicines.

TGA key transition dates:

6 March 2018:

Permitted indications reform commences. ‘Fee free’ transition period begins.

6 September 2019:

‘Fee-free’ period to transition existing listed medicines ends.

6 March 2021:

All listed medicines on the ARTG contain only permitted indications.

 

Author: Aastha Mathur Shan