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Advertising to the public

Complying with the Therapeutic Goods Advertising Code (No. 2) 2018

16 July 2020

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Definitions

These definitions are current as at 31 October 2018. Advertisers are encouraged check the source of the definition for the current definition as legislation is amended from time to time and may, on occasions, be replaced or new instruments made.

In the absence of a definition in the Act, the Regulations or the Code, the relevant normal meaning, as derived from the current edition of the Macquarie Dictionary, will apply.

Term Definition Source
Act the Therapeutic Goods Act 1989 Therapeutic Goods Advertising Code 2018
active ingredients means a therapeutically active component in a medicine's final formulation that is responsible for its physiological or pharmacological action Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
analgesic

a medicine for internal use, containing one or more of the following substances intended for the relief of aches and pains:

  1. salicylic acid, its salts, its derivatives (including aspirin) and their salts;
  2. other non-steroidal anti-inflammatory drugs;
  3. paracetamol;

not including such a medicine where:

  1. the condition for which it is designed is a self-limiting condition; and
  2. the substances mentioned in paragraphs (a)-(c) are combined with one or more other active ingredients; and
  3. the other ingredients have been included in the medicine for indications other than the relief of aches and pains
Therapeutic Goods Advertising Code 2018

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:

  1. is on the label of the goods; or
  2. is on the package in which the goods are contained; or
  3. is on any material included with the package in which the goods are contained
Subsection 3(1) 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 Therapeutic Goods Advertising Code 2018
broadcaster

in relation to an advertisement for therapeutic goods, means a person (other than a person who is required to enter those goods on the ARTG) who undertakes, as a business activity in its own right:

  1. the broadcasting of the advertisement in broadcast media; or
  2. the placement of the advertisement for such broadcasting
Section 42B of the Act
broadcast media in relation to an advertisement or generic information, means any means (other than a means declared in the Regulations to be an exempted means) by which the information is disseminated electronically in a visible or audible form or a combination of such forms Section 42B of the Act
child means an individual under the age of 18 Therapeutic Goods Advertising Code 2018
complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use Regulation 2 in the Regulations
directions for use

in relation to therapeutic goods, includes information on:

  1. appropriate doses of the goods; and
  2. the method of administration or use of the goods; and
  3. the frequency and duration of treatment for each indication of the goods; and
  4. the use of the goods by persons of particular ages or by persons having particular medical conditions
Subsection 3(1) of the Act
dispensing doctor means a medical practitioner approved under section 92 of the National Health Act 1953 Therapeutic Goods Advertising Code 2018
generic information

in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of therapeutic goods, but does not include:

  1. an advertisement about the goods; or
  2. generic information included in an advertisement about the goods; or
  3. bona fide news
Section 42B of the Act
health practitioner

means a person who, under a law of a State or internal Territory, is registered or licensed to practice in any of the following health professions:

  1. Aboriginal and Torres Strait Islander health practice;
  2. dental (not including the professions of dental therapist, dental hygienist, dental prosthetist or oral health therapist);
  3. medical;
  4. medical radiation practice;
  5. nursing;
  6. midwifery;
  7. occupational therapy;
  8. optometry;
  9. pharmacy;
  10. physiotherapy;
  11. podiatry;
  12. psychology
Subsection 3(1) of the Act
health professional

The kinds of 'health professionals' covered by section 42AA of the Act include:

  • medical practitioners
  • psychologists
  • pharmacists
  • optometrists
  • chiropractors
  • physiotherapists
  • nurses and midwives
  • dentists, dental hygienists, dental prosthetists, and dental therapists
  • osteopaths
  • the following practitioners, provided they are registered under a law of a State or Territory:
    • herbalists
    • homoeopathic practitioners
    • naturopaths
    • nutritionists
    • practitioners of traditional Chinese medicine
    • podiatrists
  • a person who is a member of an Australian branch of one of the bodies prescribed in Schedule 1 of the Therapeutic Goods Regulations 1990

Therapeutic Goods Advertising Code 2018

Section 42AA of the Act

health warning
  1. for a medicine that contains an ingredient mentioned in column 1 of the table in Schedule 1, in the circumstances set out in column 2 of that table, means the statement mentioned in column 3 of the table in Schedule 1;
  2. for a medical device or other therapeutic goods, means a statement that is required under the Act or the Regulations to be included on the label or instructions for use that warns that a person who takes or uses the device or goods as intended may:
    1. die; or
    2. 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
    3. require a medical practitioner to treat or prevent any of the following as a consequence of taking or using the device or goods:
      1. injury;
      2. disability;
      3. incapacity;
      4. impairment of any bodily function, organ or structure
Therapeutic Goods Advertising Code 2018
immediate family in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person. Part 1(2) of the Regulations
included in the Register
  1. in relation to a biological - means included in the Register under Part 3 2A of the Act; and
  2. in relation to a medical device to which Chapter 4 applies - means included in the Register under Chapter 4 of the Act
Subsection 3(1) of the Act
indications in relation to therapeutic goods, means the specific therapeutic uses of the goods Subsection 3(1) of the Act
ingredients
  1. active ingredients; and
  2. 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
Therapeutic Goods Advertising Code 2018
label

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

  1. on or attached to the goods; or
  2. on or attached to a container or primary pack in which the goods are supplied; or
  3. supplied with such a container or pack
Subsection 3(1) of the Act
mainstream media means any magazine or newspaper for consumers containing a range of news, public interest items, advertorials, advertisements or competitions Section 42B of the Act
medical device
  1. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
    1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
    2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
    3. investigation, replacement or modification of the anatomy or of a physiological process;
    4. control of conception;
    and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

aa. any instrument, apparatus, appliance, material or other article specified under subsection (2A); or

ab. any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or

  1. an accessory to an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab)
Subsection 41BD(1) of the Act
Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002 Therapeutic Goods Advertising Code 2018
medicine

means:

  1. therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human; and
  2. any other therapeutic goods declared by the Secretary, for the purpose of the definition of therapeutic device, not to be therapeutic devices
Subsection 3(1) of the Act
other therapeutic goods therapeutic goods that are not medicines, biologicals or medical devices Therapeutic Goods Advertising Code 2018
patient information leaflet

In relation to an implantable device, means:

  1. A leaflet (a patient information leaflet) that meets the requirements of subclauses (2) to (4) and clause 13A.4 must be provided with the medical device
  2. The leaflet must include the following information:
    1. information identifying the device, or the kind of device
    2. the intended purpose of the device
    3. information explaining how to use the device safely
    4. other information about the device as specified in Clause 13A.3 that the manufacturer considers would be useful for patients
  3. In particular, the leaflet must include the information specified in subclause (3)
Clause 13A.3 of Schedule 1 to the Medical Devices Regulations 2002 (as they will be amended in December 2018)
Poisons Standard means the Standard in force under section 52D of the Act at the commencement of this Code Therapeutic Goods Advertising Code 2018
presentation in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods Subsection 3(1) of the Act
price information

information about:

  1. the total purchase price of medicines that is to be paid by consumers of those medicines; and
  2. 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
Therapeutic Goods Advertising Code 2018
primary pack the complete pack in which the goods, or the goods and their container, are to be supplied to consumers Subsection 3(1) of the Act
prohibited representation

a representation referred to in subsection 42DJ(1)

Note: subregulation 6B(1) in the Regulations provides further details.

Section 42B of the Act
prominently displayed or communicated

In relation to a statement in an advertisement, means:

  1. either:
    1. 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
    2. for a spoken statement - able to be clearly heard and understood; and
  2. repeated as often as is necessary to ensure that is likely to be noticeable for a viewer or listener
Therapeutic Goods Advertising Code 2018
public health campaign

a campaign about a public health matter that is conducted, approved or funded by:

  1. the Commonwealth; or
  2. a State or Territory; or
  3. a Commonwealth, State or Territory statutory authority
Therapeutic Goods Advertising Code 2018
publisher

in relation to an advertisement for therapeutic goods, means a person (other than a person who is required to enter those goods on the ARTG) who undertakes, as a business activity in its own right:

  1. the publishing of the advertisement in specified media other than broadcast media; or
  2. the placement of the advertisement for such publication
Section 42B of the Act
publishing in relation to an advertisement, includes inserting material within the pages of an item of mainstream media Section 42B of the Act
Register

the Australian Register of Therapeutic Goods maintained under section 9A of the Act

Also referred to as the 'ARTG''.

Register
Regulations the Therapeutic Goods Regulations 1990 Therapeutic Goods Advertising Code 2018
required representation a representation referred to in subsection 42DJ(2) Section 42B of the Act
restricted representation a representation referred to in section 42DD Section 42B of the Act
specified media

in relation to an advertisement or generic information, means:

  1. mainstream media; or
  2. broadcast media; or
  3. cinematograph films; or
  4. displays about goods, including posters:
    1. in shopping malls (except inside an individual shop); and
    2. in or on public transport; and
    3. on billboards
Section 42B of the Act
sponsor

in relation to therapeutic goods, means:

  1. a person who exports, or arranges the exportation of, the goods from Australia; or
  2. a person who imports, or arranges the importation of, the goods into Australia; o
  3. a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);

but does not include a person who:

  1. exports, imports or manufactures the goods; or
  2. arranges the exportation, importation or manufacture of the goods;

on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia

Subsection 3(1) of the Act
State includes the Australian Capital Territory and the Northern Territory Subsection 3(1) of the Act
State law a law of a State, of the Australian Capital Territory or of the Northern Territory Subsection 3(1) of the Act
supply

includes:

  1. supply by way of sale, exchange, gift, lease, loan, hire or hire purchase; and
  2. supply, whether free of charge or otherwise, by way of sample or advertisement; and
  3. supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons; and
  4. supply by way of administration to, or application in the treatment of, a person
Subsection 3(1) of the Act
therapeutic goods

means goods:

  1. that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:
    1. for therapeutic use; or
    2. for use as an ingredient or component in the manufacture of therapeutic goods; or
    3. for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or
  2. included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii);

and includes biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include:

  1. goods declared not to be therapeutic goods under an order in force under section 7; or
  2. goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or
  3. goods (other than goods declared to be therapeutic goods under an order in force under section 7) for which there is a standard (within the meaning of subsection 4(1) of the Food Standards Australia New Zealand Act 1991); or
  4. goods (other than goods declared to be therapeutic goods under an order in force under section 7) which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented; or
  5. goods covered by a determination under subsection 7AA(1) (excluded goods); or
  6. goods covered by a determination under subsection 7AA(2) (excluded goods), if the goods are used, advertised, or presented for supply in the way specified in the determination
Subsection 3(1) of the Act
therapeutic use

means use in or in connection with:

  1. preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or
  2. influencing, inhibiting or modifying a physiological process in persons; or
  3. testing the susceptibility of persons to a disease or ailment; or
  4. influencing, controlling or preventing conception in persons; or
  5. testing for pregnancy in persons; or
  6. the replacement or modification of parts of the anatomy in persons
Subsection 3(1) of the Act
total purchase price

in relation to therapeutic goods, means the total cost of the goods to a consumer, including:

  1. 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
  2. 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
Therapeutic Goods Advertising Code 2018
traditional use

for a designated active ingredient, means use of the designated active ingredient that:

  1. is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and
  2. accords with well established procedures of preparation, application and dosage
Therapeutic Goods Regulations 1990
unscheduled in relation to a good, means not consisting of, or containing, a substance in a schedule to the current Poisons Standard Therapeutic Goods Advertising Code 2018

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