Using the 'TGA assessed' claim on medicine labels
Guidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
Purpose
This Guidance provides sponsors of assessed listed medicines and registered complementary medicines information on:
- what the TGA assessed claim is
- how the TGA assessed claim can be used on medicine labels and in other advertising
- how to apply to use the TGA assessed claim.
For more information, see TGA assessed claim for assessed listed and registered complementary medicines.
Please note the examples of product labels in this document are intended to provide guidance on the presentation of the TGA assessed claim only. They do not represent actual products, nor necessarily meet the requirements of the therapeutic goods labelling order or advertising requirements.
For information on requirements for labelling refer to Labelling and packaging and for information on advertising refer to the Advertising hub on the TGA's website.
The TGA assessed claim
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 symbol is the subject of an application for a certification trade mark that is currently being considered by the Registrar of Trade Marks under the Trade Marks Act 1995. It is anticipated that the application will be determined in the near future, at which time these guidelines will be revised. Once registered, use of the certification trade mark will be governed by accompanying certification rules, which will reference these guidelines.
The TGA assessed symbol and statement are shown below.
The TGA assessed symbol
An example of the TGA assessed symbol for use on labels for assessed listed medicines and registered complementary medicines.
Example label with the TGA assessed symbol
An illustrated example of medicine packaging with the TGA assessed symbol in the bottom lefthand corner of the box.
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
Example label with statement
An illustrated example of medicine packaging with the TGA assessed statement on the box. The statement reads, "Evidence for the approved indications has been assessed by the TGA."
Using the TGA assessed claim on product labels
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 Medicine labels: Guidance on 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:
- on or attached to the goods; or
- on or attached to a container or primary pack in which the goods are supplied; or
- supplied with such a container or pack.
Minimum text size for the TGA assessed symbol
The minimum text size for the letters in the word 'assessed' included in the TGA assessed symbol is 1.5 millimetres, inclusive of the ascender. Therefore, the minimum overall size of the symbol/information box is equivalent to 4.7 mm high and 9 mm wide.
Diagram showing minimum size requirements for the TGA assessed symbol on medicine labels in Australia.
The symbol is a rectangular box containing the text "TGA assessed" in two lines.
Overall dimensions are 9 mm wide by 4.7 mm high.
The text "assessed" has a minimum height of 1.5 mm for lowercase letters, measured to the top of ascenders.
Maximum text size for the TGA assessed symbol
The maximum text size for the word ‘assessed’, inclusive of the ascender, is no more than the text size of the letters for the active ingredients, warnings or other essential information included on the medicine label.
Diagram showing text size comparison for TGA assessed symbol on medicine labels.
The text 'TGA assessed' is shown, with a dotted red line indicating the maximum height of the word 'assessed'.
The line extends to text reading 'Active ingredient Xmg', demonstrating that the 'assessed' text should not exceed the height of critical information like active ingredients on the label.
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).
Included below are examples of compliant and non-compliant TGA assessed symbols.
Example of a compliant TGA assessed symbol
Compliant: Do present the symbol in black with a white background and a black outline.
An example of a compliant TGA assessed symbol, which presents the symbol in black with a white background and a black outline.
Example 1 of a non-compliant TGA assessed symbol
Non-compliant: Do not change the colour of the symbol or the outline. Do not invert the symbol.
An illustrated example of a non-compliant TGA assessed symbol, with the TGA assessed symbol shown in a pink font on a white background.
Example 2 of a non-compliant TGA assessed symbol
Non-compliant: The symbol must be presented on a white background.
An illustrated example of a non-compliant TGA assessed symbol, with the TGA assessed symbol shown in a black font on a blue background.
Example 3 of a non-compliant TGA assessed symbol
Non-compliant: Do not change the shape of the symbol or any of its elements, do not stretch or skew the symbol.
An illustrated example of a non-compliant TGA assessed symbol, with the TGA assessed symbol shown with an altered shape.
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.
Example of a TGA assessed claim (statement)
A simplified illustration of a light blue medicine box label.
On the label, there's a section titled 'Medicine information'.
Below this, a line of text is highlighted with a red oval, which reads: 'Evidence for the approved indications has been assessed by the TGA'.
Example 1 of a TGA assessed claim (symbol)
A stylised illustration of a medicine bottle label with the text 'YOUR MEDICINE' prominently displayed in black on a yellow background.
Below this is smaller text reading 'INGREDIENTS'.
In the bottom right corner is a 'TGA assessed' claim symbol with 'TGA' in large black letters and 'assessed' in smaller black letters underneath, with a white background, indicating the product has been assessed by the Therapeutic Goods Administration.
Example 2 of a TGA assessed claim (symbol)
An illustrated example of a medicine package label that reads 'MediBrand Joint relief'.
The label is primarily green and white. It shows product details including '20 Capsules' and 'active ingredient 5 mg'.
The bottom right contains an example of the 'TGA assessed' claim symbol, which contains the text 'TGA assessed' to indicate the product has been assessed by the Therapeutic Goods Administration.
Using the TGA assessed claim in other advertising materials
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 Advertising Code, 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.
Example of TGA assessed claim in advertising materials
An example of TGA assessed claim used in advertising. The example shows an advertisement for a digestive health product, Bean's tonic+ IBS relief supplement.
The image shows a woman with short blonde hair wearing a white t-shirt, holding her stomach with a pained expression.
The text reads 'GOT GAS? BE KIND TO YOUR GUTS WITH BEAN'S'.
A product bottle is displayed, labelled 'bean's tonic+ IBS relief' with green capsules beside it.
The bottle's label includes text stating 'Active Ingredient 5 mg' directly above a black and white 'TGA assessed' symbol.
Applying to use the TGA assessed claim
You can request the TGA assessed symbol file by emailing: nonprescriptionmedicines@health.gov.au. The file will be provided in an .eps format.
Copies of proposed labels displaying the TGA assessed claim must be provided to the TGA with an application:
- for a new assessed listed medicine or a new registered complementary medicine; or
- to vary the labelling of a registered complementary medicine or assessed listed medicine included in the Australian Register of Therapeutic Goods (ARTG).
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.
Page history
- Updated contact email address
Title changed from 'Guidelines for using the TGA assessed claim on medicine labels' to 'Using the 'TGA assessed' claim on medicine labels' as part of migration to new 'Guidance' content type:
- Consistent ‘Purpose’ heading.
- ‘Legislation’ section to clearly show which laws the Guidance relates to.
- ‘Page history’ section replaces document version history.
- New page navigation features.
- Updated page summaries.
- Complex images include long descriptions.
- New ‘Save as PDF’ feature.
- Clarification of measurement of the text height in line with existing TGO 92 guidance.
- Revision of minimum TGA assessed symbol dimensions to allow sponsors to use a smaller symbol, if the mandatory label information text is at the minimum height required by TGO 92.
- Updated link to the Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines.
- Addition of information regarding certification trade mark.
Original publication
- Updated contact email address
Title changed from 'Guidelines for using the TGA assessed claim on medicine labels' to 'Using the 'TGA assessed' claim on medicine labels' as part of migration to new 'Guidance' content type:
- Consistent ‘Purpose’ heading.
- ‘Legislation’ section to clearly show which laws the Guidance relates to.
- ‘Page history’ section replaces document version history.
- New page navigation features.
- Updated page summaries.
- Complex images include long descriptions.
- New ‘Save as PDF’ feature.
- Clarification of measurement of the text height in line with existing TGO 92 guidance.
- Revision of minimum TGA assessed symbol dimensions to allow sponsors to use a smaller symbol, if the mandatory label information text is at the minimum height required by TGO 92.
- Updated link to the Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines.
- Addition of information regarding certification trade mark.
Original publication