TGA assessed claim for assessed listed and registered complementary medicines
The Therapeutic Goods Administration (TGA) has implemented the 'TGA assessed' claim for sponsors of assessed listed medicines and registered complementary medicines.
In response to the Medicines and Medical Devices Regulation Review (MMDR), the Government accepted a recommendation to allow sponsors to publish a claim that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market evaluation by the TGA.
In May 2018 the TGA released a consultation paper: Options for the implementation of a claimer for efficacy assessed non-prescription medicines and sought comments on the design and implementation of the TGA assessed claim. A response has since been published on the TGA website.
What is the TGA assessed claim?
The TGA assessed claim is a symbol and/or statement that indicates that a medicine has had the efficacy for its indications (a medicine's claimed purpose or health benefit) assessed by the TGA. It can only be used in accordance with the TGA's authority.
The implementation of the TGA assessed claim is intended to:
- support consumers to make better informed purchasing decisions by improving the transparency about whether efficacy claims for certain medicines have been independently assessed by the TGA
- improve consumer awareness about the medicines regulatory framework and the different levels of assessment undertaken by the TGA
- provide an incentive for product sponsors to improve the standards of evidence and extend the evidence base for certain medicines
The TGA assessed claim is not a recommendation by the TGA and does not advocate that a medicine with the claim is better for a person than other medicines without the claim.
The TGA assessed claim is not mandatory, and therefore not all medicines whose efficacy has been assessed mau display it.
What medicines does it apply to?
Assessed listed medicines and registered complementary medicines which have undergone a pre-market assessment of efficacy by the TGA are eligible to use the TGA assessed claim on their medicine label and other advertising material.
Assessed listed medicines are different to other listed medicines.
Sponsors of listed medicines (with an 'AUST L' ARTG number) are required to hold evidence for the efficacy of their listed medicine. However, this evidence is not pre-market assessed by the TGA.
Assessed listed medicines (with an 'AUST L(A)' ARTG number) have undergone a TGA pre-market assessment of the efficacy of the medicine's indications.
Listed or registered complementary medicines that have not undergone pre-market efficacy assessment by the TGA are not eligible to use the TGA assessed claim. For example, grandfathered registered complementary medicines will not be eligible to use the TGA assessed claim unless the sponsor applies to the TGA to complete an assessment of the medicine's efficacy. Only medicines with indications supported by scientific evidence and approved for inclusion by the TGA will be eligible to use the TGA assessed claim.
Prescription and over the counter (OTC) medicines will not display the TGA assessed claim.
What does the TGA assessed claim look like?
The TGA assessed claim can be displayed as the approved symbol and/or statement. These are shown below:
How can the TGA assessed claim be used?
The specific rules of how the TGA assessed claim can be used on the label and in advertising will be set out in a legislative instrument. These rules apply to the sponsor of the medicine and also apply to advertisers of the medicine who are not the sponsor (e.g. secondary advertisers such as retailers or pharmacies).
For more information on how the TGA assessed claim can be used on medicine labels and in advertising,refer to Guidelines for using the TGA assessed claim on medicine labels
How will the TGA assessed claim be regulated?
The TGA will specify the circumstances in which the TGA assessed claim can lawfully be used in an instrument of authorisation that will be made under the Therapeutic Goods Act 1989.
An authorisation to use the TGA assessed claim is required because a claim that suggests or implies that goods have been recommended, approved or endorsed by the TGA would, unless authorised, breach the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code.
Sponsors will be required to ensure that use of the TGA assessed claim, whether on the label or otherwise, is in accordance with the instrument of authorisation. Sponsors will also be required to take steps to ensure that any advertiser of its medicine also ensures that use of the TGA assessed claim is in accordance with the instrument of authorisation.
Use of the TGA assessed claim otherwise than in accordance with the instrument of authorisation is likely to breach the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code, which may result in criminal and/or civil penalties, and/or cancellation of a medicine from inclusion in the Australian Register of Therapeutic Goods.
A sponsor seeking to use the TGA assessed claim on its label must submit the label to the TGA for approval prior to including the TGA assessed claim on its label.
How do I access the TGA assessed claim for my assessed listed or registered complementary medicine?
If a sponsor wishes to use the TGA assessed claim for a new assessed listed or new registered complementary medicine, they must provide a medicine label with the TGA assessed claim for TGA pre-market approval. For more information on applying to use the TGA assessed claim, refer to Guidelines for using the TGA assessed claim on medicine labels.
If a sponsor wishes to use the TGA assessed claim for an existing registered complementary medicine that has undergone a pre-market assessment of efficacy by the TGA, they must have their new label assessed by the TGA before the claim can be used. Applications for changes to the medicine label which only relate to the use of the TGA assessed claim can use the 'OT1' code. This will attract a RCMC1 application fee – refer to TGA's Schedule of fees and charges.
If you have any questions, please contact the Complementary and OTC Medicines Branch via phone on 1800 020 653 or via email at email@example.com.