Definitions

section 4

section 4

(Part 1)

Definitions Removed

Definitions Added

Amended definitions and notes

• approval number⁺
• approved advertisement⁺
• dispensing doctor
• ingredient
• specified media⁺
• unscheduled

+ these definitions relate to the scheme for preapproval of certain advertisements. The scheme ceased operating from 1 July 2020 with the repeal of the authorising legislation. The remaining terms and their definitions are no longer used in the Code.

• instructions for use^#
• intended purpose^#
• active ingredient^#
• class 1 medical device^#
• patient information leaflet^#
• pharmaceutical benefits scheme simplifies references to the scheme.
• pharmacy marketing group clarifies intent of provisions for price information.
• price information list defines the term throughout the Code based on the definition in sub-section 33(1).
• repatriation pharmaceutical benefits scheme simplifies references to the scheme
• serious defines the term throughout the Code based on the definition in section 28.
• short form advertisement extracted from provisions relating to this advertising. Policy intent remains unchanged for the term.
• TGO 91 simplifies references to the standard
• TGO 92 simplifies references to the standard
• trade name#
• traditional use#

# these terms have the same meaning as in the Regulations or MD Regulations.

Notes added to set out in full definitions used in the Code from the Act These definitions were current at the time of making the Code:

• health practitioner
• indications
• label
• registered goods
• supply
• intended purpose

• note for the Act's definition of advertise has been moved from section 6 (2018 Code) to note 3 in section 4
• active ingredient^#
• health professional amended to clarify it does not include purchasing officers for the purposes used in the Code
• price information amended to clarify the kinds of goods to which price information can apply.
• prominently displayed or communicated has been amended to remove redundant terms and clarify the meaning.
• health warning - separate definitions of health warning for medicines, medical devices and 'other therapeutic goods' (OTGs) are set out within the relevant provisions. For example, the definition of health warning in relation to medicines is in subsection 19(4).

# these terms have been amended to have the same meaning as in the Regulations or MD Regulations.

Object of Code

section 5

section 2

(Part 1)

Legal technical amendments to improve readability.

Application

section 6

sections 5 & 6

(Part 2)

The original provision has been separated into two sections; advertisements to which the Code applies (s5) and advertisements to which the Code does not apply (s6).

Section 6

Clarifies that:

• The Code does not apply to advertisements directed exclusively to any person listed in s42AA of the Act, not just health professionals.
• The Code, other than Part 9 does not apply to the dissemination of price information.

Transitional Arrangements

section 6B

section 5

• Code commences on 1 January 2022 with a 6-month transitions period to 30 June 2022. All advertisements must comply with 2021 code from 1 July 2022.

Price information

section 7 & schedule 4

sections 31-36

(Part 9)

• A new Part 9 has been created to bring price information into substantive provisions within the Code.
• Amended general structure and consolidated provisions without changing the intent of provisions. The definition of price information has been amended to clarify the application of the part to registered medicines in Schedules 3 (but not Appendix H), 4 and 8 of the Poisons Standard. This also clarifies that therapeutic goods that are unregistered but fall into Schedule 3, 4,or 8 of the Poisons Standard by virtue of the ingredients they contain, cannot have price information published without committing offences under applicable provisions in section 42DL of the Act.

Approved advertisements

section 8

Nil

• Abolished. The advertising pre-approvals scheme ceased from 1 July 2020.

Accuracy

section 9

section 8

(Part 3)

• moved original subsection 9(c) (2018 Code) to sch 1, section 9.

Effect

section 10

section 9

(Part 3)

• Added paragraph 9(2)(a) in relation to fear and distress
• amended heading to 'Safe and Proper use'
• Comparisons with goods 9(3)(f) has been clarified to include comparisons with therapeutic services as well as goods.

Mandatory statements

sections 11, 12, 13

sections 14-21

(Part 4)

• removed table of health warnings at schedule 1
• Requirement for all ads to display health warnings reduced to only those advertisements facilitating direct sale to consumers where the goods cannot be inspected before purchase ((in circumstances where there is a legislative instrument requiring an advisory statement on label or on information accompanying the goods).
• Part 4 - divided into 3 Divisions:
• Division 1 - preliminary
  • application (provides that the requirements in Part 4 do not apply to labels, CMI, IFU, etc.)
• Division 2 - Mandatory statements for particular advertisements
  • s15 Pharmacist only
  • s16 Therapeutic goods not available for purchase by general public
  • s17 Short form advertising
• Division 3 - mandatory statements for other advertisements
  • application (provides that the requirements in Division 3 do not apply to the advertisements mentioned in Division 2 - Pharmacist only, etc.)
  • s19 Medicines (including definitions for health warning, accepted indication and relevant instrument)
  • s20 Medical devices (including definitions for health warning, accepted t indication and relevant instrument)
  • s21 Other therapeutic goods (including definitions for health warning, accepted indication and relevant instrument)
  • ss13(5) (short form advertising) replaced by s17.

Symptoms Statement

Sub-Section 13(7), (7A) and (8)

N/A

• Requirement abolished. Advertisers are still able to use the symptom statements if desired.

Scientific/clinical representations

section 15

section 11

(Part 3)

• Added that this section does not apply to 'instructions for use' in addition to labels, consumer medicine information and patient information leaflets.

Endorsements / testimonials

sections 16 &17

section 24

(Part 6)

• Consolidated endorsements and testimonials into 1 provision at s24.
• Clarified:
  • That where a testimonial is provided by the immediate family member of a person engaged in the marketing or supply of the goods (a relevant person), that relationship must be disclosed in the advertisement.
  • current or former health professionals, health practitioners and those representing themselves as being such a person are prohibited from providing a testimonial or endorsement
  • That anyone receiving a valuable consideration for a testimonial is a “relevant person” and unable to make a testimonial (See note under s24(4)(d))

Incentives

section 18

section 26

(Part 7)

• created a new Part 7 for incentives (and samples)

Advertising to children

section 19

section 12

• clear operative provision to give effect to new table at annexure 1
• Clarification that goods that include a substance included in Schedule 2, 3, 4 or 8 of the current Poisons Standard cannot be advertised to children

Samples

section 20

section 25

(Part 7)

• created a new Part 7 for samples (and incentives)
• clear operative provision to give effect to new table at annexure 2
• Clarification that that the provision applies to the sample itself (which is an advertisement in its own right) and the offer of a sample in an advertisement.
• Clarification that goods that include a substance included in Schedule 2, 3, 4 or 8 of the current Poisons Standard cannot be offered as a sample
• for goods that are included in the Register, the sample provided must be a pack accepted in relation to the goods inclusion
• included a new definition of sample at ss25(2)

Public health campaigns

section 21

section 10

(Part 3)

• provision moved forward to an earlier section in the 2021 code to give it more prominence and to clarify that it is a general requirement for all advertising.

Requirements for particular therapeutic goods

sections 22, 23, 24, 25, 26 & 27

sch 1, sections 22 & 23

(Part 5)

• created a new Part 5 for additional requirements for advertising particular therapeutic goods (analgesics, complementary medicines, sunscreen and weight management goods).
• moved provisions forward to follow directly after mandatory statement/information
• removed provisions relating to analgesics (s24(2), 2018 Code) and vitamins (s25, 2018 Code) as these are prohibited representations. These provisions are incorporated unchanged in the Regulations. See Part 1 of Schedule 2, Items 4 and 8 respectively.

Restricted and prohibited representations

sections 28, 29 & 30

sections 28 & 29

• removed section on prohibited representations (s30, 2018 Code) - incorporated unchanged in the Regulations. See Part 1 of Schedule 2, Item 10.