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Changes made to the Therapeutic Goods Advertising Code 2018 following public consultation during April 2018

Version 1.0, October 2018

8 October 2018

Under the Therapeutic Goods Act 1989 (the Act), advertising to the public for therapeutic goods must comply with the Therapeutic Goods Advertising Code (the Code). The Code ensures that the marketing and advertising of therapeutic goods is conducted in a manner that promotes the quality use of the product, is ethical and does not mislead or deceive the consumer.

The Code is a legislative instrument made under section 42BAA of the Act by the Minister or their delegate. On 29 June 2018, the Therapeutic Goods Advertising Code 2018 (2018 Code) was made. It comes into effect on 1 January 2019. Prior to making the 2018 Code, TGA held a public consultation in April 2018 on a draft version.

We received 44 submissions in response to this consultation, which came from a range of stakeholders, including consumers, health professionals, media and industry bodies. We thank those individuals and organisations that lodged submissions for their valuable contribution. Your feedback was used in the development of the final 2018 Code.

This document sets out the differences between the 2018 Code, as made, and the draft version of the Code that was published on the TGA website for public consultation.

Part 1 - Preliminary

2 Commencement

  • The commencement date has been amended from '1 July 2018' to '1 January 2019'.

4 Definitions

  • Reference to 'complementary medicine' and 'listed' has been deleted and 'primary pack' added under 'Note'.
  • A number of new definitions have been included:
    • 'active ingredients'
    • 'approval number'
    • 'approved advertisement'
    • 'complementary medicine'
    • 'health warning'
    • 'ingredients'
    • 'other therapeutic goods'
    • 'patient information leaflet'
    • 'specified media'
  • The following definitions have been amended:
    • 'bench-mark price brand'
    • 'displayed or communicated'
    • 'price information'
    • 'prominently displayed or communicated'
    • 'public health campaign'
    • 'total purchase price'
    • 'unscheduled'

5 Object

  • The term 'marketing' has been removed.
  • In paragraph 5(a), the word 'their' has been inserted between 'minimising' and 'misuse' and the last occurrence 'of the goods' has been removed.
  • In paragraph 5(d), the word 'consistent' has been replaced with 'not inconsistent'.

6 Application of the Code

  • •Subsection 6(6) has been revised to clarify that the subsection applies only to those persons specified in subsection 6(7) who publish or broadcast genuine news no matter what the medium.

7 Price information

  • No change.

Part 2 - Requirements for advertising therapeutic goods - general

8 Approved advertisements

  • Paragraph 8(1)(a) has been amended to clarify that this section applies only to approved advertisements.

9 Accuracy

  • Paragraph 9(a) has been amended to clarify that all information presented in the advertisement must be '...substantiated before the advertising occurs'. Further, the words 'and accurate' have been inserted following 'valid'.
  • A new paragraph 9(c) based upon subsection 4(5) of the 2015 Code (comparative advertising) has been added.
  • The old paragraph 9(c) has been renumbered to 9(d).

10 Effect

  • No change.

11 What must advertisements contain - general rules

  • A new paragraph 11(1)(b) has been added to provide that section 11 does not apply to a patient information leaflet.
  • The old paragraph 11(1)(b) has been renumbered to 11(1)(c) and amended by;
    • removing 'and/' after 'goods';
    • adding 'or imply' after 'contain'; and
    • adding 'or any other representation' after 'use'.
  • The old paragraph 11(1)(c) has renumbered to 11(1)(e).
  • Paragraph 11(1)(d) has been amended for clarity by removing the phrase 'direct marketing or internet marketing' and making reference to section 12.
  • Paragraph 11(2)(a) has been amended by replacing '...other therapeutic goods legislation...' with 'Therapeutic Goods Order No 92 - Standard for labels of non-prescription medicines'.
  • Paragraph 11(2)(b) has been amended by replacing 'intended purpose of' with 'indications for'.
  • Paragraphs 11(2)(c)and (d) have been replaced by the table which specifies requirements for medicines based on whether any health warnings are required (as defined in section 4 of the Code).
    • The requirement to include a list of the ingredients (old subparagraph 11(2)(c)(ii)) and to specify where further information about the medicine can be found (old paragraph 11(2)(d)) has been removed.
    • The statement 'ALWAYS READ THE LABEL, displayed or communicated' applies only to medicines for which there are no health warnings.
    • A new requirement has been added for 'A medicine for which there are health warnings'. This includes 'either:
      1. The following statement, prominently displayed or communicated:
        THIS MEDICINE MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE; or
      2. both of the following displayed or communicated:
        ALWAYS READ THE LABEL; and the health warnings'.
  • Subsection 11(3) has been revised and now refers only to '...a medical device ...'. Reference to 'or therapeutic goods that are not medicines medical devices or biologicals' has been deleted and the requirement for 'other therapeutic goods' added to the new subsection (4) below.
  • Subsection 11(3)(a) has been amended to refer to the 'device' rather than 'goods'.
  • Paragraph 11(3)(b) has been amended by revising the text to read '(i) if the trade name for the device is available - a reference to that name or (ii) otherwise - a reference to another name for the device.'
  • Paragraph 11(3)(c) has been amended by adding 'or indications for' after 'intended purpose of,'.
  • Paragraph 11(3)(d) and (e) have been replaced by the table which specifies requirements for devices based on whether any health warnings are required.
    • The statement 'ALWAYS READ THE LABEL, displayed or communicated' has been retained for 'a device for which there are no health warnings'. Further, the option to use the alternative statement 'ALWAYS READ THE INSTRUCTIONS FOR USE' has been provided 'as appropriate for the packaging of the device'.
    • A new requirement has been added for 'A device for which there are health warnings'. This includes:
      • '(a) where the label of the device is visible on the primary pack, one of the following:'
        1. THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE, prominently displayed or communicated or
        2. ALWAYS READ THE LABEL and the health warnings, displayed or communicated'.
      • '(b) where the device does not have a label visible on the primary pack, one of the following:'
        1. THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE INSTRUCTIONS FOR USE BEFORE PURCHASE, prominently displayed or communicated or
        2. ALWAYS READ THE INSTRUCTIONS FOR USE and the health warnings, displayed or communicated'.
  • A new subsection 11(4) has been added for 'other therapeutic goods' which sets out similar requirements to those specified for devices under subsection 11(3).
  • The old subsection 11(4) has been renumbered to subsection 11(5) and amended by adding reference to paragraphs 114(d) and by increasing the number of written characters to '300'.

12 What must advertisements contain - goods that are not available for physical examination before purchase

  • Heading of this section has been amended for clarity to 'What advertisements must contain - goods that are not available for physical examination before purchase'.
  • A new subsection 12(1) has been added for further clarity - 'this section applies to advertisements for goods that are not available physical examination by the consumer before or at the time of purchase'.
  • A note has also been added under subsection 12(1) to clarify that section 12 'does not apply to advertisements covered by section 11'.
  • A new subsection 12(2) has been added to provide that section 12 'does not apply to a label, consumer medicine information or a patient information leaflet'.
  • A new subsection 12(3) has been added setting out the requirements for those statements in section 12 that must be prominently displayed or communicated.
  • The old subsection 12(1) has been renumbered to subsection 12(4) and amended to 'An advertisement for a medicine must contain...'.
  • Old paragraph 12(1)(a) has been renumbered to 12(4)(a) and amended by replacing '...other therapeutic goods legislation...' with 'Therapeutic Goods Order No 92 - Standard for labels of non-prescription medicines'.
  • A new paragraph 12(4)(b) has been added requiring 'the name of the dosage form of the medicine, within the meaning of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines'.
  • A new paragraph 12(4)(c) has been added requiring 'the quantity of the medicine, within the meaning of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines'.
  • Old paragraph 12(1)(b) has been renumbered to paragraph 12(4)(d) and amended to 'the indications for the medicine'.
  • Old paragraph 12(1)(c) has been renumbered to paragraph 12(4)(e).
  • Old paragraph 12(1)(d) has been renumbered to paragraph 12(4)(f) and replaced by the table which specifies requirements for medicines based on whether any health warnings are required (as defined in section 4 of the Code).
    • The statement 'ALWAYS READ THE LABEL, displayed or communicated' applies only to medicines for which there are no health warnings.
    • A new requirement has been added for 'A medicine for which there are health warnings'. This includes 'either:
      1. The following statement, prominently displayed or communicated:
        THIS MEDICINE MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE; or
      2. (b) both of the following displayed or communicated:
        ALWAYS READ THE LABEL; and the health warnings'.
  • Old paragraph 12(1)(e) has been renumbered to paragraph 12(4)(g). Reference to subsection 13(4) has changed to subsection 13(3) due to renumbering of section 13. Further, reference to and subsection 14 and to 'on each page that features the medicine' has been removed.
  • Old paragraph 12(1)(f) has been renumbered to paragraph 12(4)(h). Reference to subsection (13)(3) and to 'on each page that features the medicine' has been removed. A reference to section 23 has been added.
  • Old paragraph 12(1)(g) has been renumbered to paragraph 12(4)(i) and now references 'any other mandatory warnings or advisory statements that are required to be included on the label...'. Further, reference to 'on each page that features the medicine' has been removed.
  • Old paragraph 12(1)(h) has been subsumed into new provisions relating to health warnings.
  • The old subsection 12(2) has been renumbered to subsection 12(5) and amended to 'An advertisement for a medical device must contain...'.
  • Old paragraph 12(2)(a) has been renumbered to paragraph 12(5)(a).
  • Old paragraph 12(2)(b) has been renumbered to paragraph 12(5)(b)and amended by adding the option to reference another name for the device where the trade name is not available.
  • Old paragraph 12(2)(c) has been renumbered to paragraph 12(5)(c)and amended by adding '...or indications for, the device'.
  • A new paragraph 12(5)(d) has been added to include 'a list of ingredients for the device, where relevant'.
  • Old paragraph 12(2)(d) has been renumbered to paragraph 12(5)(e) and replaced by the table which specifies requirements for devices based on whether any health warnings are required (as defined in section 4 of the Code).
    • The statements 'ALWAYS READ THE LABEL, or ALWAYS READ THE INSTRUCTIONS FOR USE displayed or communicated' applies only to devices for which there are no health warnings.
    • A new requirement has been added for 'A device for which there are health warnings'. This includes 'either:
      1. The following statement, prominently displayed or communicated:
        THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE; or
      2. both of the following displayed or communicated:
        ALWAYS READ THE LABEL or ALWAYS READ THE INSTRUCTIONS FOR USE; and the health warnings'.
  • Old paragraph 12(2)(e) has been renumbered to paragraph 12(5)(f). Reference to subsection 13(4) has changed to subsection 13(3) due to renumbering of section 13. Further, reference to 'on each page that features the device' has been removed.
  • Old paragraph 12(2)(f) has been renumbered to paragraph 12(5)(g). Reference to subsection (13)(3) and to 'on each page that features the device' has been removed.
  • Old paragraph 12(2)(g) has been renumbered to paragraph 12(5)(h) and now references 'any other mandatory warnings or advisory statements that are required to be provided with the device ...'. Further, reference to 'on each page that features the device' has been removed.
  • Old paragraph 12(2)(h) has been subsumed into new provisions above relating to health warnings.
  • Old subsection 12(3) has been subsumed into new provisions above related to health warnings.
  • Old subsection 12(4) has been renumbered to subsection 12(6) and amended to 'An advertisement for other therapeutic goods must contain...'.
  • Old paragraph 12(4)(a) has been renumbered to paragraph 12(6)(a).
  • Old paragraph 12(4)(b) has been renumbered to paragraph 12(6)(b) and amended to by adding the option to reference another name for the goods where the trade name is not available.
  • Old paragraph 12(4)(c) has been renumbered to paragraph 12(6)(c) and amended by adding '...or indications for, the goods'.
  • A new paragraph 12(6)(d) has been added to include 'a list of ingredients for the device, where relevant'.
  • A new paragraph 12(6)(e) has been added. It contains the table which specifies requirements for goods based on whether any health warnings are required (as defined in section 4 of the Code).
    • The statements 'ALWAYS READ THE LABEL, or ALWAYS READ THE INSTRUCTIONS FOR USE displayed or communicated' applies only to goods for which there are no health warnings.
    • A new requirement has been added for 'goods for which there are health warnings'. This includes 'either:
      1. The following statement, prominently displayed or communicated:
        THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE; or
      2. both of the following displayed or communicated:
        ALWAYS READ THE LABEL or ALWAYS READ THE INSTRUCTIONS FOR USE; and the health warnings'.
  • A new paragraph 12(6)(f) has been added for consistency with the subsections 12(4) and (5). It requires the statement prescribed by subsection 13(3) (as applicable) to be prominently displayed or communicated in the advertisement.
  • A new paragraph 12(6)(g) has been added for consistency with the subsections 12(4) and (5). It requires the statement prescribed by subsection (13)(2) to be displayed or communicated in the advertisement.
  • A new paragraph 12(6)(h) has been added for consistency with the subsections 12(4) and (5). It requires 'any other mandatory warnings or advisory statements that are required to be provided with the good, displayed or communicated'.
  • Old paragraph 12(4)(d) has been subsumed into new provisions relating to health warnings.

13 Required statements

  • Subsection 13(1) has been amended for consistency with subsection 11(1).
  • Old subsections 13(2) and (3) have been combined into new subsection 13(2); 'An advertisement must contain either of the following statements (as appropriate), displayed or communicated
  • FOLLOW THE DIRECTIONS FOR USE; or
  • FOLLOW THE INSTRUCTIONS FOR USE'.
  • Old subsection 13(4) has been renumbered to subsection 13(3) and amended by adding the words 'statements as appropriate to duration of recurrence of the symptoms'. The mandatory statement prescribed by old subsection 13(4) has been split into two statements to provide advertisers with an option based upon '...duration or recurrence of the symptoms, prominently displayed or communicated:
  • IF SYMPTOMS PERSIST, TALK TO YOUR HEALTHCARE PROFESSIONAL; or
  • IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTHCARE PROFESSIONAL'.
  • Old subsection 13(5) has been renumbered to subsection 13(4) and amended for consistency with subsection 11(5).

14 Required statement - pharmacist-only medicines

  • A new subsection 14(1) has been added for consistency with subsection 11(1).
  • The existing provision has been renumbered to subsection 14(2).

15 Scientific representations

  • A new subsection 15(1) has been added to been added to provide that section 15 does not apply to a label, consumer medicine information or a patient information leaflet.
  • Old paragraphs 15(a) and (d) have been grouped together under new subsection 15(2) as paragraphs (a) and (b) respectively and apply to advertisements that make a scientific or clinical claim.
  • Old paragraphs 15(b) and (c) have been grouped together under new subsection 15(3) as paragraphs (a) and (b) respectively and apply to advertisements that contain a citation to scientific literature.

16 Endorsements

  • A new subsection 16(1) has been added to clarify that 'this section does not apply to a testimonial covered by section 17'.
  • Old subsection 16(1) has been renumbered to subsection 16(2).
  • Old paragraph 16(1)(d) has been deleted.
  • Old subsection 16(2) has been renumbered to subsection 16(3).
  • Old paragraph 16(2)(b) has been renumbered to paragraph 16(3)(b) and amended by adding the term 'contractor' and changing the reference to 'subsection 1' to 'paragraph (2)(b) or (c)'.

17 Testimonials

  • New subsection 17(1) has been added to clarify that 'a testimonial means a statement about a therapeutic good made by a person that claims to have used that good'.
  • Old subsection 17(1) has been renumbered to subsection 17(2).
  • Old subparagraph 17(1)(a)(i) has been renumbered to subparagraph 17(2)(a)(i) and amended by clarifying that the persons '...details are verified prior to the advertising occurring'.
  • Old subparagraph 17(1)(a)(iii)(B) has been deleted.
  • Old subparagraph 17(1)(a)(iii)(C) has been renumbered to subparagraph 17(2)(a)(iii)(B) and the term 'marketing' has been removed.
  • New subparagraphs 17(2)(a)(iii)(C) and (D) have been added and refer to 'a body corporate' and those 'mentioned in subsection 16(2)' respectively.
  • Old subparagraph 17(1)(b) has been renumbered to subparagraph 17(2)(b) and amended to clarify that the claims made the person are 'verified ...prior to the advertising occurring'.
  • Old subsection 17(2) has been renumbered to subsection 17(3).
  • Old subparagraph 17(2)(c) has been removed and replaced by new subparagraph 17(3)(c) requiring disclosure of 'where the person providing the testimonial is a relative or associate of an individual who is involved with the production, sale or supply of the goods'.

18 Incentives

  • This section has been amended by referencing 'health professional' which is defined.

19 Advertising to children

  • New subsection 19(1) has been added to clarify that 'this section does not apply to labels'.
  • Old subsections 19(1) and (2) have been renumbered to subsections 19(2) and (3) respectively and amended to clarify that the advertising '...must not be primarily directed to children...'.
  • New subsection 19(4) has been added to clarify that 'subsection (3) does not apply where the goods are mentioned in Schedule 2 and advertised in accordance with any applicable conditions in that Schedule' and subsection(3) modified accordingly.

20 Samples

  • Old section 20 - Allergies - has been subsumed into new provisions relating to health warnings.
  • A new section 20 has been inserted dealing with 'Samples'.
  • New subsection 20(1) is based upon the existing subsection 4(8) of the 2015 Advertising Code and requires that 'an advertisement for therapeutic goods must not contain an offer of a sample'.
  • New subsection 20(2) clarifies that 'subsection (1) does not apply where the goods are mentioned in Schedule 3 and advertised in accordance with any applicable conditions in that Schedule'.

21 Consistency with public health campaigns

  • No change.

Part 3 - Rules relating to particular therapeutic goods

22 Application

  • This section has been amended to provide that section 15 does not apply to a label, consumer medicine information or a patient information leaflet.

23 Complementary medicines

  • This section has been amended by adding 'or group of claims' after 'claim' and moving 'and paradigm' to after the second occurrence of 'traditional use'.

24 Analgesics

  • No change.

25 Vitamins and minerals

  • Subsection numbering removed. No change to text.

26 Weight management

  • Subsection 26(3)(b) (at the end) has been amended by removing reference to the words 'expected to be' and the word 'typical' so that it now reads '...unless the results achieved by those individuals from the use of the goods would be expected to be achieved on average by users of the goods'.

27 Sunscreens

  • New subsection 27(1) has been added to clarify that 'this section applies to an advertisement for a sunscreen that claims or implies that the sunscreen will prevent any of the following:
    1. sunburn;
    2. skin cancer'.

Part 4 - Restricted representations and prohibited representations

28 Restricted representations - serious form of disease, condition, ailment or defect

  • Old paragraph 28(a) has been renumber to paragraph 28(1)(a) and amended by replacing the words 'and' with 'or', 'healthcare' with 'health' and adding the exception 'where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management'.
  • Old paragraph 28(b) has been deleted.
  • Old paragraph 28(c) has been renumbered to paragraph 28(1)(b) and amended to read 'there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self-administered test), which requires medical interpretation or follow-up'.
  • New subsection (2) has been added to clarify that 'subsection (1) does not apply to the diseases mentioned in section 30'.

29 Restricted representations - public interest criteria

  • No change.

30 Prohibited representations

  • Paragraph 30(b) has been amended by replacing 'or' after 'prevention' with ',', deleting 'of' after 'diagnosis' and adding the following text '...(including screening), monitoring or susceptibility of, or pre-disposition to,...'

Schedule 1 - Price Information

1 Purpose

  • No change.

2 Application

  • No change.

3 Who may provide price information

  • No change.

4 Responsibility for compliance with this Schedule

  • Amended to clarify that the persons who:
    1. publish, by any means, price information for therapeutic goods; or
    2. cause the publication, by any means, of price information for therapeutic goods
  • are responsible for ensuring compliance with the Price Information Schedule.

5 Methods for provision of price information

  • Paragraphs 5(2)(a) and 5(2)(b) have been amended by deleting the following text at the end of each paragraph; '...and the dosage form, strength and quantity of each medicine as relevant'.

6 General requirement restricting promotion

  • Paragraph 6(2)(c) has been amended by deleting the word 'particular' and adding after 'multiple packs' the following text '...that are not approved sponsor pack sizes or multiples of those sizes, except as provided under clause 7 of this Schedule'.

7 Description of medicines

  • Subsection 7(1) has been amended by adding 'within the meaning of whichever is relevant to the medicine:
    1. the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines; or
    2. the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines'.
  • Subsection 7(2) has been amended by adding a new paragraph;
    • '(d) the quantity contained in the sponsor's standard pack'.

8 Presentation of price information

  • No change.

9 Pharmaceutical Benefits Scheme subsidised medicines

  • No change.

Schedule 2 - Advertising to children

1 Goods that may be advertised to children

  • The word 'years' has been added after 'children aged 12'
  • Paragraph 1(f) has been amended by inserting the words 'Class 1 medical' before the word 'devices...'.

Schedule 3 - Samples

1 Goods that may be offered as samples

  • A new schedule that permits the offer of samples of condoms and sunscreens in advertisements (consistent with existing subsection 4(8) of the 2015 Advertising Code).

Version history
Version Description of change Author Effective date
V1.0 Original publication Advertising Compliance Unit, Regulatory Education and Compliance Branch 08/10/2018