Using the 'TGA assessed' claim on medicine labels

The TGA assessed claim can be used to indicate that a medicine has had the efficacy of its indications assessed by the TGA. The claim must only be used in relation to assessed listed medicines or registered complementary medicines.

The claim must be displayed as the approved TGA assessed statement, with or without the approved TGA assessed symbol.

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 may display it.

The TGA assessed symbol is a certification trade mark in the Register of Trade Marks under the Trade Marks Act 1995. The ® symbol or the words “registered trade mark” signifies that the trade mark is protected and prevents others from using it without our permission or using a similar mark that could cause confusion for consumers.  

Sponsors may choose to include the wording “The TGA Assessed trade mark is a registered certification trade mark owned by The Crown in Right of the Commonwealth of Australia, Department of Health and Aged Care, Therapeutic Goods Administration and used by [name of company] under licence.” but are not compelled to. However, sponsors are encouraged to include the ® symbol or the word “registered trade mark” next to the TGA assessed symbol however there is no legal obligation to do so. 

What medicines it applies 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.

The TGA assessed symbol and statement are shown below.

If the symbol is used, a statement authorised by the TGA must also be used (see below).

The TGA assessed statement

The statement may be used on its own without the TGA assessed symbol. The wording of the TGA assessed statement must not be changed.

Examples of compliant and non-compliant statements

Compliant: Evidence for the approved indications has been assessed by the TGA.

Non-compliant: The TGA has assessed our evidence and has approved all of our indications.

Example medicine label with TGA assessed statement

The TGA assessed claim may only be used in relation to a medicine when that use has been authorised by the TGA.

Authorisation to use the TGA assessed claim will only be issued for assessed listed medicines and registered complementary medicines that have undergone a pre-market assessment of efficacy by the TGA. 

The TGA assessed claim must be easily identifiable on medicine labels. The label of the medicine that will display the TGA assessed claim is also assessed as part of this process.

The TGA assessed symbol and statement are standardised for easy identification on different product types. The requirements for using the TGA assessed claim on a medicine label are provided below.

Location of the TGA assessed claim on a product label

The TGA assessed claim (the TGA assessed statement, with or without the TGA assessed symbol) can be displayed anywhere on the label, including the primary pack.

The TGA assessed claim must be balanced against other information on the main label and primary pack to assist consumers in selecting and using a medicine.

The size of the TGA assessed claim must not be more prominent than required label information. 

For more information on labelling requirements refer to TGO 91 and TGO 92.

Section 3(1) of the Therapeutic Goods Act 1989 provides the following definitions of primary pack and label:

primary pack, in relation to therapeutic goods, means the complete pack in which the goods or the goods and their container, are to be supplied to consumers.

label, in relation to therapeutic goods, means a display of printed information:

(a) on or attached to the goods; or

(b) on or attached to a container or primary pack in which the goods are supplied; or

(c) supplied with such a container or pack.

TGA assessed statement

The minimum text size for the TGA assessed statement is 1.5 millimetres.

The maximum text size for the TGA assessed statement is no more than the text size for the names and amounts of active ingredients, warnings or other essential information included on the medicine label.

Font style and colour of TGA assessed claim

TGA assessed symbol

The TGA assessed symbol must be presented in black ink on a white background and surrounded by a black outline (as provided to the sponsor in an .eps file by the TGA). The Registered trade mark symbol needs to be displayed in the top righthand corner in superscript.

Included below are examples of compliant and non-compliant TGA assessed symbols.

TGA assessed statement

To allow sponsors some flexibility in label design, you can choose the font style and colour for the TGA assessed statement; however, it must:

• be presented in a colour that contrasts strongly with the background it is printed on; and
• be consistent with the font style, colour and prominence of the surrounding label text, warnings or other essential information.

The sentence must be written in lower case, with the exception of the first letter of the sentence and TGA, as shown below.

Examples of compliant and non-compliant TGA assessed statements

Compliant: Evidence for the approved indications has been assessed by the TGA.

Non-compliant: EVIDENCE FOR THE APPROVED INDICATIONS HAS BEEN ASSESSED BY THE TGA.

The specific rules of how the TGA assessed claim can be used on the label and in advertising is set out in the Therapeutic Goods (TGA Assessed Claim) Authorisation 2020 (authorisation 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).

How the TGA assessed claim is regulated

The Therapeutic Goods (TGA Assessed Claim) Authorisation 2020 (authorisation instrument) specifies the circumstances in which the TGA assessed claim can lawfully be used, and is 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 (Therapeutic Goods Advertising Code) Instrument 2021.

Sponsors are required to ensure that use of the TGA assessed claim, whether on the label or otherwise, is in accordance with the authorisation instrument. 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 authorisation instrument.

Use of the TGA assessed claim other than in accordance with the authorisation instrument is likely to breach the Therapeutic Goods Act 1989 and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, 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.

Advertisements may show images of the medicine label, including the TGA assessed claim (the TGA assessed statement with or without the TGA assessed symbol), but must not use the TGA assessed symbol or statement other than on the image of the label in the pack shot.

An advertisement must not include any audible commentary or further written commentary on the TGA assessed claim.

The TGA assessed claim must not be more prominent than the mandatory statements in an advertisement.

The use of the TGA assessed claim in any advertising must comply with the advertising requirements set out in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, as amended from time to time.

The advertising must not imply that the TGA recommends the medicine or advocates the use of the medicine above other medicines that do not use the TGA assessed claim.

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. 

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.

You can request the TGA assessed symbol file by emailing: nonprescriptionmedicines@health.gov.au. The file will be provided in an .eps format.

In considering a label in relation to a medicine, the TGA will consider all aspects of the medicine's presentation for compliance with the various legislative requirements.

Authorisation to use the TGA assessed claim will not be given in relation to a medicine where the presentation of that medicine (with the TGA assessed claim) is not acceptable - refer to the Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines for further information.