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Think-Tank-Permitted-Indications-for-listed-medicines.pdf (7 MB)

Listed Complementary Medicines are classified by the Therapeutic Goods Administration (TGA) as low risk medicines. As such, they can be listed on the Australian Register of Therapeutic Goods (ARTG) via a self-assessment mechanism provided they are compliant with legislative requirements. Prior to listing, sponsors must hold the appropriate documentation including evidence to support the indications and claims made for their medicine.

‘Indications’ are statements that describe the therapeutic use of a medicine and it’s claimed purpose or health benefit. They are categorised into the following types:

+ Specific indications: e.g. refer to a non-serious condition

+ Non-specific indications: e.g. refer to general health maintenance

On 6th March 2018, the TGA introduced a ‘list of permitted indications’ contained in the Therapeutic Goods (Permissible Indications) Determination under Section 26A of the Therapeutic Goods Act 1989. This Determination provides a comprehensive list of low level indications acceptable for listed medicines including complementary medicines and sunscreens.

Introduction of this pre-approved list ensures that sponsors only use indications referring to:

+ Health maintenance

+ Health enhancement

+ Prevention of a non-serious vitamin or mineral dietary deficiency; or

+ Certain non-serious, self-limiting diseases, ailments, defects or injuries

Whereas sponsors were previously able to add their own indications using the ‘free-text field’ in the electronic listing application, this option was removed and replaced with a function to select the most appropriate indication(s) from the pre-approved list.

The Determination also includes the evidence type (Scientific, Traditional, Traditional Chinese medicine or Traditional Ayurvedic) 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 on the medicine label.

Benefits of the new permitted indications list include:

+ Transparency on suitable indications for low risk listed medicine

+ Prevent sponsor non-compliance

+ Protect consumers from misleading and inappropriate claims

+ Prevent unsafe or inappropriate use of the medicine

Transition period

There is a 3-year transition period for sponsors of existing listed medicines to re-list their products using permitted indications. The transition period ends 6 March 2021.

By this date all listed medicines must contain only permitted indications. Those listed medicines which have not yet transitioned to the new system, will be cancelled.

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

https://www.tga.gov.au/publication/permitted-indications-listed-medicines-guidance

 

Author: Aastha Mathur Shan