I, Tracey Lutton, as delegate of the Secretary of the Department of Health, Disability and Ageing, make the following permission.
Dated 13 May 2026
Tracey Lutton
Assistant Secretary
Regulatory Compliance Branch
Health Products Regulation Group
Department of Health, Disability and Ageing
Contents
- Schedule 1 - Permission: restricted representations
- Schedule 2 - Permission: prohibited representations
- Schedule 3 - Repeals
1 Name
This instrument is the Therapeutic Goods (Prohibited and Restricted Representations—Government Health Campaigns) Permission 2026.
2 Commencement
- Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | The day after this instrument is made. |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
- Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under section 42DK of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
advertise;
included in the Register;
indications;
listed goods;
medical device;
medicine;
Register;
registered goods;
State;
therapeutic goods;
Therapeutic Goods Advertising Code.
In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Therapeutic Goods Regulations 1990.
Class 3 IVD medical device has the same meaning as in the MD Regulations.
Class 4 IVD medical device has the same meaning as in the MD Regulations.
Commonwealth health campaign means a campaign about a public health matter that is conducted, approved or funded by the Commonwealth.
IVD medical device for self-testing has the same meaning as in the MD Regulations.
MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
prohibited representation means a representation referred to in subsection 42DJ(1) of the Act.
registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.
restricted representation means a representation referred to in section 42DD of the Act.
serious, in relation to a form of a disease, condition, ailment or defect, has the same meaning as in the Therapeutic Goods Advertising Code.
specified advertisement means an advertisement that is, or forms part of, a Commonwealth health campaign or a State health campaign.
State health campaign means a campaign about a public health matter that is conducted, approved or funded by a State.
Note: State is defined in subsection 3(1) of the Act as including the Australian Capital Territory and the Northern Territory.
5 Permission
- For subsection 42DK(1) of the Act, in relation to each item in the table in Schedule 1, the representations specified in column 2 (to the extent that those representations are restricted representations) are permitted to be used in a specified advertisement about the therapeutic goods specified in column 3, subject to the conditions (if any) specified in column 4.
- For subsection 42DK(3) of the Act, in relation to each item in the table in Schedule 2, the representations specified in column 2 (to the extent that those representations are prohibited representations) are permitted to be used in a specified advertisement about the therapeutic goods specified in column 3, subject to the conditions (if any) specified in column 4.
6 Repeals
Each instrument that is specified in Schedule 3 is repealed as set out in the applicable items in that Schedule.
Schedule 1 - Permission: restricted representations
Note: See subsection 5(1).
| Permitted use of restricted representations | |||
|---|---|---|---|
| Column 1 | Column 2 | Column 3 | Column 4 |
| Item | Representation | Therapeutic goods | Conditions |
| 1 | a representation that refers, expressly or by implication, to a serious form of a disease, condition, ailment or defect, and that promotes the use or supply of the therapeutic goods | therapeutic goods, other than vaccines, that are:
| the advertisement must not be inconsistent with the following:
|
| 2 | a representation that refers, expressly or by implication, to a serious form of a disease that may be prevented, treated, alleviated or cured by the therapeutic goods | vaccines that are registered goods | the advertisement must not be inconsistent with the indication of the therapeutic goods that is accepted in relation to the registration of the goods in the Register, or any conditions of registration relating to the goods |
Schedule 2 - Permission: prohibited representations
Note: See subsection 5(2).
| Permitted use of prohibited representations | |||
|---|---|---|---|
| Column 1 | Column 2 | Column 3 | Column 4 |
| Item | Representation | Therapeutic goods | Conditions |
| 1 | a representation regarding the use of the therapeutic goods as pre‑exposure prophylaxis to prevent, or reduce the risk of, sexually acquired human immunodeficiency virus (HIV) | a registered medicine that:
| the advertisement must not be inconsistent with the indication of the therapeutic goods that is accepted in relation to the registration of the goods in the Register, or any conditions of registration relating to the goods |
| 2 | a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility to:
| an IVD medical device for self‑testing that:
| the advertisement must not be inconsistent with the intended purpose of the therapeutic goods that is accepted in relation to the inclusion of the goods in the Register, or any conditions of inclusion relating to the goods |
| 3 | a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre‑disposition to, sexually transmitted diseases | an IVD medical device for self‑testing that:
| the advertisement must not be inconsistent with the intended purpose of the therapeutic goods that is accepted in relation to the inclusion of the goods in the Register, or any conditions of inclusion relating to the goods |
| 4 | a representation to the effect that the therapeutic goods may help to reduce the risk or transmission of:
| condoms that are included in the Register | the advertisement must not be inconsistent with the intended purpose of the therapeutic goods that is accepted in relation to the inclusion of the goods in the Register, or any conditions of inclusion relating to the goods |
| 5 | a representation regarding the prevention of one or more of the following:
| vaccines that are registered goods that have an indication accepted in relation to the registration of the goods in the Register that relates to the prevention of HPV | the advertisement must not be inconsistent with the indication of the therapeutic goods that is accepted in relation to the registration of the goods in the Register, or any conditions of registration relating to the goods |
| 6 | a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre‑disposition to, hepatitis C virus (HCV) | therapeutic goods that are registered goods or included in the Register | the advertisement must not be inconsistent with the indication or the intended purpose of the therapeutic goods that is accepted in relation to the registration or inclusion of the goods in the Register, or any conditions of registration or inclusion relating to the goods |
| 7 | a representation to the effect that the therapeutic goods may assist in preventing, or may reduce the risk of, some skin cancers | sunscreen products that have a sun protection factor of 30 or higher, and are registered goods or listed goods | the advertisement must not be inconsistent with the indication of the therapeutic goods that is accepted in relation to the registration or listing of the goods in the Register, or any conditions of registration or listing relating to the goods |
| 8 | a representation regarding the treatment, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre‑disposition to, mental illness | software that is a medical device included in the Register | the advertisement must not be inconsistent with the intended purpose of the therapeutic goods that is accepted in relation to the inclusion of the goods in the Register, or any conditions of inclusion relating to the goods |
Schedule 3 - Repeals
Note: See section 6.
Therapeutic Goods (Prohibited Representations—Government Health Campaigns) Permission 2019
1 The whole of the instrument
Repeal the instrument.
Therapeutic Goods (Restricted Representations—Government Health Campaigns) (COVID-19) Permission 2022
2 The whole of the instrument
Repeal the instrument.
Therapeutic Goods (Restricted Representations—Government Health Campaigns) Permission 2019
3 The whole of the instrument
Repeal the instrument.