You are here

Therapeutic goods advertising compliance, 2018-19 annual report

25 October 2019

Book pagination

Appendix 1 - Glossary of advertising provisions

Therapeutic Goods Act 1989

Subsection Description
42DL(12) Advertising offences - general: This subsection applies to the advertisement if it refers to therapeutic goods that are not entered in the Register and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).
42DL(7)(a) Advertising offences - general: This subsection applies to the advertisement if it contains a restricted representation (whether in express terms or by necessary implication) and neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation.
42DL(10) Advertising offences - general: This subsection applies to the advertisement if it refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).
42DL(5)(a) Advertising offences - general: This subsection applies to the advertisement if it contains a prohibited representation (whether in express terms or by necessary implication) about the goods and no permission under section 42DK is in force in relation to the prohibited representation.
42DLB(9) Civil Penalty provision - This subsection applies to the advertisement if it refers to therapeutic goods that are not entered in the Register and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).
41ML(3) False advertising about medical devices: A person commits an offence if the person, by any means, advertises a medical device as being for a purpose; and the device is of a kind included in the Register; and the purpose is not a purpose accepted in relation to that inclusion.
42DLB(7) Civil Penalty provision - This subsection applies to the advertisement if it refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).
42DLB(4)(a) Civil Penalty provision - This subsection applies to the advertisement if it contains a restricted representation (whether in express terms or by necessary implication) and neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation.
42DLB(2)(a) Civil Penalty provision - This subsection applies to the advertisement if it contains a prohibited representation (whether in express terms or by necessary implication) about the goods and no permission under section 42DK is in force in relation to the prohibited representation.
42DMA Civil penalty - non-compliance with the Therapeutic Goods Advertising Code
42DM Offences - non-compliance with the Therapeutic Goods Advertising Code
42DL(9) Suggesting goods approved by government authority
22(5) General offences relating to this Part: A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion.
42DM(3) Offences - non-compliance with the Therapeutic Goods Advertising Code: A person commits an offence if the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods; and (b) the advertisement does not comply with the Therapeutic Goods Advertising Code.
42DLB(5) Civil penalty relating to advertisements - general: This subsection applies to the advertisement if it contains a reference to this Act, other than in a statement of the registration number, listing number or device number of the goods.
42DLB(4) Civil penalty relating to advertisements - general: This subsection applies to the advertisement if it contains a restricted representation (whether in express terms or by necessary implication) and either of the following applies: (a) neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation; (b) an approval under section 42DF or a permission under section 42DK is in force in relation to the restricted representation but the use of the restricted representation is not in accordance with the approval or permission or a condition of the approval or permission.
41ML(1)(d)(ii) False advertising about medical devices: A person commits an offence if the use of the medical device for the advertised purpose, if the medical device were so used, would result in, or would be likely to result in, harm or injury to any person.

Therapeutic Goods Advertising Code 2015

Subsection Description
4(2)c General Principles - An advertisement for therapeutic goods must not: mislead, or be likely to mislead, directly or by implication or through emphasis, comparisons, contrasts or omissions
4(6)b(iii) Professional Recommendation - Advertisements must not contain or imply endorsement by: individual or groups of health professionals referred to in section 42AA of the Act or any other person or group of persons represented directly or indirectly to be health professionals, other than where the emphasis is on the
4(1)b General Principles - An advertisement for therapeutic goods must: contain correct and balanced statements only and claims which the sponsor has already verified.
4(7) Testimonials: Testimonials must not breach the Code. They must be documented, genuine, not misleading and illustrate typical cases only.
4(2)i An advertisement for therapeutic goods must not: contain any claim, statement or implication that the goods are safe or that their use cannot cause harm or that they have no side-effects
5(2) Prohibitions: An advertisement for therapeutic goods must not refer, expressly or by implication, to serious forms of diseases, conditions, ailments or defects specified in Part 2 of Appendix 6, unless prior approval is given under the Act.
4(8) Samples: An advertisement for therapeutic goods (other than therapeutic devices and sun screening preparations) must not contain an offer of a sample.
4(2)b An advertisement for therapeutic goods must not: be likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases
4(2)d An advertisement for therapeutic goods must not: abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or distress
4(2)e(i) An advertisement for therapeutic goods must not: contain any matter which is likely to lead persons to believe that they are suffering from a serious ailment
4(2)e(ii) An advertisement for therapeutic goods must not: contain any matter which is likely to lead persons to believe that harmful consequences may result from the therapeutic good not being used.
4(2)f An advertisement for therapeutic goods must not: encourage, or be likely to encourage, inappropriate or excessive use
4(2)j An advertisement for therapeutic goods must not: be directed to minors, except the therapeutic goods listed in Appendix 5.
4(5) Comparative advertisements must be balanced and must not be misleading or likely to be misleading, either about the therapeutic goods advertised or the therapeutic goods, or classes of therapeutic goods, with which it is compared. Points of comparison should be factual and reflect the body of scientific evidence. Comparisons should not imply that the therapeutic goods, or classes of therapeutic goods, with which comparison is made, are harmful or ineffectual.
4(2)a An advertisement for therapeutic goods must not: be likely to arouse unwarranted and unrealistic expectations of product effectiveness
4(6)c

Advertisements must not contain or imply endorsement of the goods by bodies or peak health professional associations that: (i) represent the interests of health consumers; (ii) conduct or fund research into a disease, condition disorder or syndrome; or (iii) represent health professionals, unless: (iv) the advertisement names the body or association; (v) the endorsement is authenticated; (vi) the nature of the endorsement is clearly disclosed; and (vii) the endorsement is based upon an objective assessment of available scientific data supporting the use of that product. Where this is not the case and where the body or association has received valuable consideration for the endorsement, the advertisement must acknowledge that consideration.

6(3) An advertisement for therapeutic goods shall contain: the trade name of the goods; a reference to the approved/permitted indication(s) for the use of the goods; information outlined in 6(3)c to f

Book pagination