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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This code sets the rules for advertising medicines, medical devices and other therapeutic goods to Australian consumers. It requires truthful, balanced claims, clear safety and ingredient warnings, and forbids endorsements by health professionals or unapproved claims about serious diseases.
It also restricts ads to children, imposes special warnings for common ingredients and product types (e.g., painkillers, weight-loss, sunscreens), and applies to all consumer-directed advertising (excluding health‑professional communications and genuine news).
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Direct links to the current provisions in Therapeutic Goods Advertising Code (No.2) 2018.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
This instrument is the Therapeutic Goods Advertising Code (No.2) 2018.
This instrument is made under subsection 42BAA(1) of the Therapeutic Goods Act 1989.
Note: A number of expressions used in this instrument are defined in the definitions section of the Act, including the following:
(a) advertise;
(b) current Poisons Standard;
(c) directions for use;
(d) health practitioner;
(e) included in the Register;
(f) indications;
(g) Register;
In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredients has the same meaning as in the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines.
advertiser means a person who:
advertises, by any means, therapeutic goods; or
causes the advertising, by any means, of therapeutic goods.
analgesic means a medicine for internal use, containing one or more of the following substances intended for the relief of aches and pains:
salicylic acid, its salts, its derivatives (including aspirin) and their salts;
other non-steroidal anti-inflammatory drugs;
paracetamol;
not including such a medicine where:
the condition for which it is designed is a self-limiting condition; and
the substances mentioned in paragraphs (a)-(c) are combined with one or more other active ingredients; and
the other ingredients have been included in the medicine for indications other than the relief of aches and pains.
approval number has the same meaning as in section 42B of the Act.
approved advertisement has the same meaning as in section 42B of the Act.
bench-mark price brand, in relation to a multi branded medicine, means the lowest priced product within the group of medicines that are listed on the Pharmaceutical Benefits Scheme as brands of the same medicine.
child means an individual under the age of 18.
complementary medicine has the same meaning as in the Regulations.
dispensing doctor means a medical practitioner approved under section 92 of the National Health Act 1953.
health professional means a person mentioned in section 42AA of the Act.
health warning means:
in relation to a medicine that contains an ingredient mentioned in column 1 of an item in a table in Schedule 1, in the circumstances set out in column 2 of that item―the statement mentioned in column 3 of that item;
in relation to a medical device or other therapeutic goods―a statement that is required under the Act, Regulations or Medical Devices Regulations to be included on the label, or in the instructions for use, of the device or goods, and is to the effect that:
(i) a person who takes, or uses, the device or goods as intended may:
(A) die; or
(B) require hospitalisation or a longer period of hospitalisation than would be required if the person had not taken, or used, the device or goods; or
(C) require a medical practitioner to treat or prevent an injury, disability, incapacity, or impairment (the latter in relation to a bodily function, organ or structure), as a consequence of taking, or using, the device or goods; or
(ii) the device or goods should not be taken, or used, in certain circumstances, which are described by reference to one or more of the following:
(A) a serious form, within the meaning of subsection 28(1), of a disease, condition, ailment or defect;
(B) an implantable device;
(C) a specific class of persons;
(D) pregnancy.
Note: A statement referred to in subparagraph (b)(ii) may be in the form of “DO NOT USE IF” followed by a reference to one of the matters mentioned in sub-subparagraphs (b)(ii)(A) to (D).
immediate family has the same meaning as in the Regulations.
ingredients means:
active ingredients; and
substances or groups of substances that are required to be on the label of the medicine under paragraph 8(1)(j) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines.
Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
other therapeutic goods means therapeutic goods that are not medicines, biologicals or medical devices.
patient information leaflet has the same meaning as in clause 13A.3 of Schedule 4 to the Medical Devices Regulations.
price information, in relation to prescription medicines and pharmacist-only medicines, means information about:
the total purchase price of medicines that is to be paid by consumers of those medicines; and
for medicines that are listed on the Pharmaceutical Benefits Scheme (or Repatriation Pharmaceutical Benefits Scheme), the price paid by the consumer when the prescription is dispensed.
prominently displayed or communicated, in relation to a statement in an advertisement, means:
either:
for a visual statement—standing out so as to be easily read from a reasonable viewing distance for the particular media type in the context in which the advertisement is intended to be viewed; or
for a spoken statement—able to be clearly heard and understood; and
repeated as often as is necessary to ensure that it is likely to be noticeable for a viewer or listener.
public health campaign means a campaign about a public health matter that is conducted, approved or funded by:
the Commonwealth; or
a State or Territory; or
a Commonwealth, State or Territory statutory authority.
Regulations means the Therapeutic Goods Regulations 1990.
specified media has the same meaning as in section 42B of the Act.
total purchase price, in relation to therapeutic goods, means the total cost of the goods to a consumer, including:
the administration, handling and infrastructure fee, any mark-up payable to the pharmacist, dispensing fee, additional fee or allowable extra fee if applied by the pharmacist; and
in relation to Pharmaceutical Benefits Scheme and Repatriation Pharmaceutical Benefits Scheme prescriptions—any premium (such as a brand or therapeutic group premium or special patient contribution) that must be paid by the consumer.
unscheduled, in relation to a good, means not consisting of, or containing, a substance included in a schedule to the current Poisons Standard.
The Object of this instrument is to ensure that the advertising of therapeutic goods to consumers is conducted in a manner that:
promotes the safe and proper use of therapeutic goods by minimising their misuse, overuse or underuse; and
is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance; and
supports informed health care choices; and
is not inconsistent with current public health campaigns.
Subject to subsection (2), this instrument applies to the advertising of therapeutic goods.
Note: In subsection 3(1) of the Act, advertise is defined as follows:
Note: advertise, in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:
(a) is on the label of the goods; or
(b) is on the package in which the goods are contained; or
(c) is on any material included with the package in which the goods are contained.
This instrument does not apply to an advertisement that:
(a) is directed exclusively to health professionals; or
(b) is part of, or otherwise comprises, a public health campaign; or
(c) is made in accordance with the Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission (No. 4) 2021 made under section 42DK of the Act, as in force or existing on 24 September 2021.
(d) is made in accordance with the Therapeutic Goods (Restricted Representations—HHD Group Pty Limited) (AZ) Permission 2021 made under section 42DK of the Act, as in force or existing on 24 August 2021.
Note 1: The Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission (No. 4) 2021 is published at www.tga.gov.au.
Note 2: The Therapeutic Goods (Restricted Representations—HHD Group Pty Limited) (AZ) Permission 2021 is published at www.tga.gov.au.
This instrument applies, in relation to a particular advertisement, by reference to its likely impact on a reasonable person to whom the advertisement is directed. In applying this instrument to an advertisement, the total presentation and context of the advertisement is to be taken into account. This instrument applies to any person who:
advertises, by any means, therapeutic goods; or
causes the advertising, by any means, of therapeutic goods.
However, this instrument does not apply to genuine news that is broadcast or published in any medium by a person mentioned in subsection (7). For subsection (6), the persons are a broadcaster, a datacaster, the SBS or a person of a kind prescribed by the Regulations for the purposes of paragraphs 42DLB(10)(a) or 42DMA(2)(a) of the Act.
Note 1: In subsections 42DLB(11) and 42MA(3), broadcaster, datacaster and SBS are defined as follows:
Note: broadcaster has the meaning given by clause 3 of Schedule 2 to the Broadcasting Services Act 1992.
Note: datacaster means a person who holds a datacasting licence (within the meaning of the Broadcasting Services Act 1992).
Note: SBS has the same meaning as in the Special Broadcasting Service Act 1991.
Note 2: For the purposes of paragraphs 42DLB(10)(a) or 42DMA(2)(a) of the Act, the Regulations prescribe a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.
In this section –
former Code means the Therapeutic Goods Advertising Code 2015, as in force immediately before the commencement of this instrument. transition period, for an advertisement for therapeutic goods to which subsection (2) applies, means the period beginning on the commencement of this instrument, and ending on either of the following, whichever first occurs:
the day on which the approval number for the advertisement expires, in accordance with subregulation 5J(3) of the Regulations; and
for an advertisement for which approval is withdrawn in accordance with regulation 5L of the Regulations, the day on which approval is withdrawn.
Despite the repeal of the former Code made by section 6A, the former Code continues to apply for the duration of the transition period in relation to advertisements for therapeutic goods that were approved under Division 2 of Part 2 of the Regulations before the commencement of this instrument.
This instrument, other than Schedule 4, does not apply to advertising that consists solely of the dissemination of price information for medicines that are registered goods. For the purposes of subsections 42DL(10) and 42DLB(7) of the Act, to the extent that the dissemination of price information in relation to therapeutic goods mentioned in those subsections constitutes advertising, the dissemination is authorised if it complies with Schedule 4.
Note: The rules in this Part apply generally in relation to advertisements for therapeutic goods. For advertisements for the particular therapeutic goods identified in Part 3, the rules in Part 3 may also apply.
This section applies only to advertisements:
that are approved advertisements to which Part 2 of the Regulations applies; and
that are published in media referred to in paragraph (a) or (d) of the definition of specified media in section 42B of the Act.
The advertisement must include the approval number allocated to the advertisement under the Regulations. The approval number must:
stand alone; and
be legible; and
be located in the bottom right hand corner of the advertisement.
Advertising for therapeutic goods must satisfy the following:
any claims made in the advertising are valid and accurate, and all information presented has been substantiated before the advertising occurs; and
it is truthful, balanced and not misleading or likely to mislead, including in its claims, presentations, representations and comparisons; and
any comparisons made in the advertising between therapeutic goods or classes of therapeutic goods do not directly or indirectly claim that the goods or class of goods being used as the comparator are harmful or ineffectual; and
if the goods are included in the Register— it is consistent with the entry for the therapeutic goods in relation to that inclusion.
Advertising for therapeutic goods must:
support the safe and proper use of therapeutic goods by:
presenting the goods in accordance with directions or instructions for use; and
not exaggerating product efficacy or performance; and
not be likely to lead to people delaying necessary medical attention or delaying the use of, or failing to use, treatment prescribed by a medical practitioner; and
not encourage inappropriate or excessive use of the therapeutic goods; and
not contain any claim, statement, implication or representation that:
the therapeutic goods are safe or that their use cannot cause harm, or that they have no side-effects; or
the therapeutic goods are effective in all cases of a condition or that the outcome from their use is a guaranteed or sure cure; or
the therapeutic goods are infallible, unfailing, magical or miraculous; or
harmful consequences may result from the therapeutic goods not being used — unless the claim, statement, implication or representation is permitted under section 42DK of the Act or approved under section 42DF of the Act.
This section does not apply to:
a label or consumer medicine information; or
a patient information leaflet; or
an advertisement displaying only the name or picture of therapeutic goods or their price or point of sale, or any combination of these, provided the advertisement does not contain or imply a claim relating to therapeutic use, or any other representation.
An advertisement for therapeutic goods consisting of, or containing, a substance included in Schedule 3 of the current Poisons Standard and Appendix H of that Standard, must contain the following statement, prominently displayed or communicated:
ASK YOUR PHARMACIST—THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU
This section applies to advertisements for therapeutic goods that are not available for physical examination by the consumer before or at the time of purchase, other than advertisements to which section 11 applies. This section does not apply to:
a label or consumer medicine information; or
a patient information leaflet.
An advertisement for a medicine must contain the following:
the name of the medicine, within the meaning of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines;
the name of the dosage form, within the meaning of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines;
the quantity of the medicine, within the meaning of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines;
at least one of the indications of the medicine, as the indication appears on the medicine’s label, or as modified in a manner that does not change the meaning or intent of the indication as it appears on the medicine’s label;
a list of the ingredients;
the requirements specified in th
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