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Therapeutic Goods Advertising Code (No.2) 2018

Authoritative Version
Codes & Codes of Practice as made
This instrument repeals both the Therapeutic Goods Advertising Code 2015 and the Therapeutic Goods Advertising Code 2018 and sets out the requirements for the advertising of medicines, medical devices and other therapeutic goods, and includes information both about statements which are required to be included in advertising material, and statements, representations or implications which must not be included in such advertising.
Administered by: Health
Made 31 Oct 2018
Registered 31 Oct 2018
Tabled HR 26 Nov 2018
Tabled Senate 12 Nov 2018
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods Advertising Code (No.2) 2018

I, Adjunct Professor John Skerritt, as delegate of the Minister for Health, make the following Code.

Dated 31 October 2018          

(Signed by)

ADJUNCT PROFESSOR JOHN SKERRITT

Deputy Secretary

Health Products Regulation Group

Department of Health

 

 

 

 


Contents

Part 1—Prelimary                                                                                                         1

1 Name ........................................................................................................................................ 1

2 Commencement......................................................................................................................... 1

3 Authority................................................................................................................................... 1

4 Definitions................................................................................................................................. 1

5 Object........................................................................................................................................ 4

6 Application................................................................................................................................ 5

6A Repeal..................................................................................................................................... 5

6B Transitional arrangements....................................................................................................... 5

7 Price information....................................................................................................................... 5

 

Part 2—General requirements for advertising therapeutic goods                           5

8 Approved advertisements.......................................................................................................... 5

9 Accuracy................................................................................................................................... 6

10 Effect....................................................................................................................................... 6

11 Pharmacist only medicine (required statement)........................................................................ 7

12 What must advertisements contain - goods that are not available for physical examination before purchase      7

13 What must advertisements contain - general rules................................................................. 10

14 Section left blank intentionally............................................................................................... 13

15 Scientific representations....................................................................................................... 13

16 Endorsements........................................................................................................................ 14

17 Testimonials.......................................................................................................................... 15

18 Incentives.............................................................................................................................. 15

19 Advertising to children.......................................................................................................... 15

20 Samples................................................................................................................................. 15

21 Consistency with public health campaigns............................................................................ 16

Part 3—Specific requirements relating to particular therapeutic goods                16

22 Application............................................................................................................................ 16

23 Complementary medicines..................................................................................................... 16

24 Analgesics............................................................................................................................. 16

25 Vitamins and minerals........................................................................................................... 16

26 Weight Management.............................................................................................................. 17

27 Sunscreens............................................................................................................................ 17

Part 4—Restricted representations and prohibited representations                      18

28 Restricted representations—serious form of disease, condition, ailment or defect................. 18

29 Restricted representations—public interest criteria................................................................ 18

30 Prohibited representations..................................................................................................... 18

Schedule 1—Medicines with specific health warnings                    20

1  Medicines mentioned in paragraph (a) of the 'health warning' definition                             20

Schedule 2—Advertising to children                                               30

1 Goods that may be advertised to children................................................................................ 30

Schedule 3—Samples                                                                       31

                                1  Goods that may be offered as samples                                                                                  31

Schedule 4—Price Information                                                        32

1 Purpose................................................................................................................................... 32

2 Application.............................................................................................................................. 32

3 Who may provide price information........................................................................................ 32

4 Responsibility for compliance with this Schedule................................................................... 32

5 Methods for provision of price information............................................................................ 32

6 General requirement restricting promotion.............................................................................. 33

7 Description of medicines......................................................................................................... 34

8 Presentation of price information............................................................................................. 34

9 Pharmaceutical Benefits Scheme subsidised medicines........................................................... 35

Schedule 5Repeals                                                                         36

Therapeutic Goods Advertising Code 2015………………………………………………………………………………….36

Therapeutic Goods Advertising Code 2018………………………………………………………………………………….36

 


Part 1Preliminary

1 Name

                   This instrument is the Therapeutic Goods Advertising Code (No.2) 2018.

                

2 Commencement

(1)                 Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument, except for Part 4 of Schedule 1

1 January 2019.

1 January 2019

2. Part 4 of Schedule 1

1 September 2020.

1 September 2020

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)                 Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

                   This instrument is made under subsection 42BAA(1) of the Act.

4 Definitions

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:

(a)      advertises, by any means, therapeutic goods; or

(b)     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:

(a)              salicylic acid, its salts, its derivatives (including aspirin) and their salts;

(b)     other non-steroidal anti-inflammatory drugs;

(c)      paracetamol;

not including such a medicine where:

(d)             the condition for which it is designed is a self-limiting condition; and

(e)      the substances mentioned in paragraphs (a)-(c) are combined with one or more other active ingredients; and

(f)      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

(a)      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;

(b)     for a medical device or other therapeutic goods, means a statement that is required under the Act, Regulations or Medical Devices Regulations to be included on the label or in instructions for use that warns that a person who takes or uses the device or goods as intended may:

(i)     die; or

(ii)   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

(iii) require a medical practitioner to treat or prevent any of the following as a consequence of taking or using the device or goods:

(A)  injury;

(B)  disability;

(C)  incapacity;

(D)  impairment of any bodily function, organ or structure.

immediate family has the same meaning as in the Regulations.

ingredients means:

(a)      active ingredients; and

(b)     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:

(a)      the total purchase price of medicines that is to be paid by consumers of those medicines; and

(b)     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:

(a)              either:

(i)     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

(ii)   for a spoken statement—able to be clearly heard and understood; and

(b)             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:

(a)              the Commonwealth; or

(b)     a State or Territory; or

(c)      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:

(a)      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

(b)     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.

5 Object

                   The Object of this instrument is to ensure that the advertising of therapeutic goods to consumers is conducted in a manner that:

(a)      promotes the safe and proper use of therapeutic goods by minimising their misuse, overuse or underuse; and

(b)     is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance; and

(c)      supports informed health care choices; and

(d)     is not inconsistent with current public health campaigns.

6 Application

(1)                 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:

                   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.

(2)                 This instrument does not apply to advertisements directed exclusively to health professionals.

(3)                 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.

(4)                 In applying this instrument to an advertisement, the total presentation and context of the advertisement is to be taken into account.

(5)                 This instrument applies to any person who:

(a)      advertises, by any means, therapeutic goods; or

(b)     causes the advertising, by any means, of therapeutic goods.

(6)                 However, this instrument does not apply to genuine news that is broadcast or published in any medium by a person mentioned in subsection (7).

(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:

                   broadcaster has the meaning given by clause 3 of Schedule 2 to the Broadcasting Services Act 1992.

                   datacaster means a person who holds a datacasting licence (within the meaning of the Broadcasting Services Act 1992).

                   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.

6A Repeal

                   The instruments specified in Schedule 5 are repealed.

6B Transitional arrangements

(1)                 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:

(a)              the day on which the approval number for the advertisement expires, in accordance with subregulation 5J(3) of the Regulations; and

(b)     for an advertisement for which approval is withdrawn in accordance with   regulation 5L of the Regulations, the day on which approval is withdrawn.

(2)                 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.

7 Price information

(1)                 This instrument, other than Schedule 4, does not apply to advertising that consists solely of the dissemination of price information.

(2)                 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.

Part 2—General requirements for the advertising of therapeutic goods

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.

8 Approved advertisements

(1)                 This section applies only to advertisements:

(a)              that are approved advertisements to which Part 2 of the Regulations applies; and

(b)     that are published in media referred to in paragraph (a) or (d) of the definition of specified media in section 42B of the Act.

(2)                 The advertisement must include the approval number allocated to the advertisement under the Regulations.

(3)                 The approval number must:

(a)      stand alone; and

(b)     be legible; and

(c)      be located in the bottom right hand corner of the advertisement.

9 Accuracy

Advertising for therapeutic goods must satisfy the following:

(a)              any claims made in the advertising are valid and accurate, and all information presented has been substantiated before the advertising occurs; and

(b)     it is truthful, balanced and not misleading or likely to mislead, including in its claims, presentations, representations and comparisons; and

(c)      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

(d)     if the goods are included in the Register— it is consistent with the entry for the therapeutic goods in relation to that inclusion.

10 Effect

Advertising for therapeutic goods must:

(a)              support the safe and proper use of therapeutic goods by:

(i)     presenting the goods in accordance with directions or instructions for use; and

(ii)   not exaggerating product efficacy or performance; and

(b)             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

(c)      not encourage inappropriate or excessive use of the therapeutic goods; and

(d)             not contain any claim, statement, implication or representation that:

(i)     the therapeutic goods are safe or that their use cannot cause harm, or that they have no side-effects; or

(ii)   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

(iii) the therapeutic goods are infallible, unfailing, magical or miraculous; or

(iv) 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.

11 Pharmacist-only medicines (required statement)

(1)                 This section does not apply to:

(a)              a label or consumer medicine information; or

(b)     a patient information leaflet; or

(c)      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.

(2)                 An advertisement for a medicine 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

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

(1)                 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.

(2)                 This section does not apply to:

(a)              a label or consumer medicine information; or

(b)     a patient information leaflet.

(3)                 An advertisement for a medicine must contain the following:

(a)              the name of the medicine, within the meaning of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines;

(b)     the name of the dosage form, within the meaning of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines;

(c)      the quantity of the medicine, within the meaning of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines;

(d)     one or more of the indications for the medicine, as they appear on the medicine’s label;

(e)      a list of the ingredients;

(f)      the requirements specified in the following table in relation to the type of medicine specified:

 

Type of medicine

Requirements

A medicine for which there are no health warnings

The following statement, prominently displayed or communicated:

ALWAYS READ THE LABEL

A medicine for which there are health warnings

Either:

(a) the following statement, prominently displayed or communicated, followed immediately by information about where the health warnings can be found:

     THIS MEDICINE MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE; or

(b) both of the following, prominently displayed or communicated:

(i)  the following statement:

            ALWAYS READ THE LABEL; and

(ii) the health warnings.

 

(g)      the required statement mentioned in subsection 13(6) (as applicable), prominently displayed or communicated;

(h)     the required statement or statements mentioned in subsection 13(7) (as applicable), displayed or communicated;

(4)                 An advertisement for a medical device must contain the following:

(a)      an accurate description of the device;        

(b)     either—

(i)     if the trade name for the device is available—a reference to that name;

(ii)   otherwise—a reference to another name for the device; or

(c)              the intended purpose of, or indications for, the device, as they appear on the device’s label or primary packaging, as appropriate to the device;

(d)             a list of ingredients for the device, where relevant;     

(e)              the requirements specified in the following table in relation to the type of device specified:

 

Type of device

Requirements

A device for which there are no health warnings

One of the following statements, as appropriate for the packaging of the device, prominently displayed or communicated:

(a) ALWAYS READ THE LABEL; or

(b) ALWAYS READ THE INSTRUCTIONS FOR USE

A device for which there are health warnings

One of the following:

(a) the following statement, prominently displayed or communicated, followed immediately by information about where the health warnings can be found:

     THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE; or

 (b) both of the following, prominently displayed or communicated:

 (i) one of the following statements, as appropriate for the packaging of the device:

(A)  ALWAYS READ THE LABEL; or

(B)  ALWAYS READ THE INSTRUCTIONS FOR USE; and

(ii)  the health warnings.

 

(f)              the required statement mentioned in subsection 13(6) (as applicable), prominently displayed or communicated;

(g)              the required statement or statements mentioned in subsection 13(7) (as applicable), prominently displayed or communicated;

(5)                 An advertisement for other therapeutic goods must contain the following:

(a)              an accurate description of the goods;

(b)     either—

(i)     if the trade name for the goods is available—a reference to that name; or

(ii)   otherwise—a reference to another name for the goods;

(c)              the intended purpose of, or indications for, the goods, as they appear on the label for the goods or its primary packaging, as appropriate to the goods;

(d)     a list of ingredients for the goods, where relevant;

(e)      the requirements specified in the following table in relation to the type of goods specified:  

 

Type of goods

Requirements

Other therapeutic goods for which there are no health warnings

One of the following statements, as appropriate for the packaging of the goods, prominently displayed or communicated:

(a) ALWAYS READ THE LABEL; or

(b) ALWAYS READ THE INSTRUCTIONS FOR USE

Other therapeutic goods for which there are health warnings

One of the following:

(a) the following statement, prominently displayed or communicated, followed immediately by information about where the health warnings can be found:

     THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE; or

 (b) both of the following, prominently displayed or communicated:

 (i) one of the following statements, as appropriate for the packaging of the goods:

(A)  ALWAYS READ THE LABEL; or

(B)  ALWAYS READ THE INSTRUCTIONS FOR USE; and

(ii)  the health warnings.

(f)              the required statement mentioned in subsection 13(6) (as applicable), prominently displayed or communicated;

(g)      the required statement or statements mentioned in subsection 13(7) (as applicable), prominently displayed or communicated.

13 What must advertisements contain—general rules

(1)                 This section does not apply to:

(a)      a label or consumer medicine information; or

(b)     a patient information leaflet; or

(c)      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; or

(d)     an advertisement for a medicine to which section 11 applies; or

(e)      an advertisement to which section 12 applies.

(2)                 An advertisement for a medicine must contain the following:

(a)      a reference to the name of the medicine, within the meaning of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines;

(b)     one or more of the indications for the medicine, as they appear on the medicine’s label;

(c)      subject to subsection (5)—the requirements specified in the following table in relation to the type of medicine specified:

 

Type of medicine

Requirements

A medicine for which there are no health warnings

The following statement, prominently displayed or communicated:

ALWAYS READ THE LABEL

A medicine that includes an ingredient in Part 1 or 2 of Schedule 1 for which there are health warnings

Either:

(a) the following statement, prominently displayed or communicated:

     THIS MEDICINE MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE; or

(b) both of the following, prominently displayed or communicated:

(i)  the following statement:

      ALWAYS READ THE LABEL; and

(ii) the health warnings.

(3)                 An advertisement for a medical device must contain the following:

(a)              an accurate description of the device;

(b)     either—

(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;

(c)      a reference to the intended purpose of, or indications for, the device;

(d)             subject to subsection (5)—the requirements specified in the following table in relation to the type of device specified:

 

Type of device

Requirements

A device for which there are no health warnings

One of the following statements, as appropriate for the packaging of the device, prominently displayed or communicated:

(a) ALWAYS READ THE LABEL; or

(b) ALWAYS READ THE INSTRUCTIONS FOR USE

A device for which there are health warnings

Where the label of the device is visible on the primary pack, one of the following:

(a) the following statement, prominently displayed or communicated:

     THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE; or

b) both of the following, prominently displayed or communicated:

(i)  ALWAYS READ THE LABEL; and

(ii) the health warnings.

 

Where the device does not have a label visible on the primary pack, one of the following:

(a) the following statement, prominently displayed or communicated:

     THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE INSTRUCTIONS FOR USE BEFORE PURCHASE; or

b) both of the following, prominently displayed or communicated:

(i)  ALWAYS READ THE INSTRUCTIONS FOR USE; and

(ii) the health warnings.

(4)                 An advertisement for other therapeutic goods must contain the following:

(a)              an accurate description of the goods;

(b)     either—

(i)     if the trade name for the goods is available—a reference to that name; or

(ii)   otherwise—a reference to another name for the goods;

(c)              a reference to the intended purpose of, or indications for, the goods;

(d)             subject to subsection (5)—the requirements specified in the following table in relation to the type of goods specified:

 

Type of goods

Requirements

Other therapeutic goods for which there are no health warnings

One of the following statements, as appropriate for the packaging of the goods, prominently displayed or communicated:

(a) ALWAYS READ THE LABEL; or

(b) ALWAYS READ THE INSTRUCTIONS FOR USE

Other therapeutic goods for which there are health warnings

Where the label of the goods is visible on the primary pack, one of the following:

(a) the following statement, prominently displayed or communicated:

     THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE; or

(b) both of the following, prominently displayed or communicated:

(i)  the following statement:

            ALWAYS READ THE LABEL; and

      (ii) the health warnings.

 

Where the goods do not have a label visible on the primary pack, one of the following:

(a) the following statement, prominently displayed or communicated:

     THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE INSTRUCTIONS FOR USE BEFORE PURCHASE; or

(b) both of the following, prominently displayed or communicated:

(i)  the following statements:

ALWAYS READ THE INSTRUCTIONS   FOR USE; and

 (ii) the health warnings.

(5)                 Paragraphs (2)(c), (3)(d) and (4)(d) do not apply to radio advertisements that are 15 seconds or less in duration or to text only advertisements that consist of 300 characters or less for which there is no reasonable capacity to include pictures, logos or other imagery as part of the advertisement.

(6)                 An advertisement must contain either of the following statements as appropriate, prominently displayed or communicated:

(a)              FOLLOW THE DIRECTIONS FOR USE; or

(b)     FOLLOW THE INSTRUCTIONS FOR USE.

(7)                 Subject to subsection (7A), if an advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain either or both of the following statements as appropriate to the duration or recurrence of the symptoms, prominently displayed or communicated:

(a)              IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or

(b)     IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL

(7A)       For an advertisement to which subsection (7) applies and which must contain both statements in that subsection, the statements may be shortened and combined into one statement, so as to avoid duplication.

(8)                 Subsection (7) does not apply to radio advertisements that are 15 seconds or less in duration or to text only advertisements that consist of 300 characters or less for which there is no reasonable capacity to include pictures, logos or other imagery as part of the advertisement.

14 Section 14 is intentionally not used.

15 Scientific or clinical representations

(1)                 This section does not apply to:

(a)      a label or consumer medicine information; or

(b)     a patient information leaflet.

(2)                 Where an advertisement makes a scientific or clinical representation:

(a)      any scientific or clinical terminology must be appropriate, clearly communicated and able to be readily understood by the audience to whom it is directed; and

(b)     any scientific or clinical representation must be consistent with the body of scientific or clinical evidence applicable to the advertised therapeutic goods.

(3)                 Where an advertisement contains a citation to scientific or clinical literature, either explicitly or impliedly:

(a)      any research results must identify the researcher and financial sponsor of the research, where the advertiser knows, or ought reasonably to have known, that information; and

(b)     the study must be sufficiently identified to enable consumers to access it.

16 Endorsements

(1)                 This section does not apply to:

(a)              a testimonial to which section 17 applies; or

(b)     for a medicine listed in the Register under paragraph 26AE(3)(a) of the Act, a statement, pictorial representation or design prescribed in the Regulations for the purposes of paragraphs 42DL(9)(c) and 42DLB(6)(c) of the Act.

(2)                 Subject to subsection (2A), an advertisement for therapeutic goods must not contain an endorsement from, or imply that the therapeutic goods are endorsed by:

(a)              a government authority, hospital or healthcare facility; or

(b)     an employee or contractor of a government authority, hospital or healthcare facility; or

(c)      a health practitioner, health professional, medical researcher or a group of such persons.

(2A)       For the purposes of paragraph (2)(a), a healthcare facility does not include a community pharmacy.

(3)                 An advertisement for therapeutic goods must not contain an endorsement from, or imply that the therapeutic goods are endorsed by:

(a)              an organisation that:

(i)     represents the interests of healthcare consumers; or

(ii)   represents the interests of health practitioners, health professionals or medical researchers; or

(iii) conducts or funds research into any disease, condition, ailment or defect; or

(b)             an employee or contractor of an organisation mentioned in paragraph (a), other than an individual mentioned in paragraph (2)(b) or (c);

unless the advertisement:

(c)      names the organisation; and

(d)     discloses:

(i)     the nature of the endorsement; and

(ii)   whether the organisation, or employee, has received, or will receive, any valuable consideration for the endorsement.

(4)                 For the purposes of subsection (3), an organisation means any group, association or body (whether incorporated or unincorporated).

17 Testimonials

(1)                 For the purposes of this section, a testimonial means a statement about a therapeutic good made by a person that claims to have used that good.

(2)                 A testimonial used in an advertisement for therapeutic goods must be:

(a)              made by a person:

(i)     whose details are verified prior to the advertising occurring; and

(ii)   who has used the goods for their intended purpose; and

(iii) who is not:

(A)    involved with the production, sale, supply or marketing of the goods; or

(B)     an employee or officer of a corporation that is involved with the production, sale, supply or marketing of the goods; or

(C)     a corporation; or

(D)    mentioned in subsection 16(2); and       

(b)             verified as to the use of the goods and the claims made by the person prior to the advertising occurring; and

(c)      typical of the results to be expected from the use of the goods in accordance with the directions for use, or purpose, of the goods.

(3)                 A testimonial must disclose:

(a)              whether the person providing the testimonial has received, or will receive, any valuable consideration for the testimonial; and

(b)     where another person is taking the place in the advertisement of the person providing the testimonial; and

(c)      where the person providing the testimonial is an immediate family member of an individual who is involved with the production, sale, supply or marketing of the goods.       

18 Incentives

An advertisement must not offer any personal incentive to a pharmacy assistant, or any retail sales person who is not a health professional, to recommend or supply therapeutic goods.

19 Advertising to children

(1)                 This section does not apply to labels.

(2)                 An advertisement for therapeutic goods must not be primarily directed to children under the age of 12 years in any circumstances.

(3)                 An advertisement for therapeutic goods must not be primarily directed to children aged 12 years or over.

(4)                 Subsection (3) does not apply where the goods are mentioned in Schedule 2 and advertised in accordance with any applicable conditions in that Schedule.

20 Samples

(1)                 An advertisement for therapeutic goods must not contain an offer of a sample.

(2)                 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

If a relevant public health campaign of which the advertiser knows, or ought reasonably to have known, is or will be current at the time of advertising therapeutic goods, the promotion of the goods must not be inconsistent with the public health campaign.

Part 3—Specific requirements for the advertising of particular therapeutic goods

Note:          The rules in this Part apply in addition to the rules in Part 2, in relation to advertisements for the particular therapeutic goods mentioned in each section.

22 Application

This Part does not apply to:

(a)              a label or consumer medicine information; or

(b)     a patient information leaflet.

23 Complementary medicines

If an advertisement for a complementary medicine includes a claim or group of claims based on evidence of a history of traditional use, the reliance on this traditional use and paradigm must be disclosed in the advertisement and the disclosure must be prominently displayed or communicated in the advertisement.

24 Analgesics

(1)                 An advertisement for an analgesic must contain the following warning statement, prominently displayed or communicated:

INCORRECT USE COULD BE HARMFUL

(2)                 An advertisement for an analgesic must not imply that:

(a)              analgesic consumption is safe; or

(b)     analgesics will relax, relieve tension, sedate or stimulate.   

25 Vitamins and minerals

                   An advertisement for vitamin or mineral supplements must not claim or imply that the supplements:

(a)              are a substitute for good nutrition or a balanced diet; or

(b)     are in any way superior to or more beneficial than dietary nutrients.         

26 Therapeutic goods that are for weight management

(1)                 An advertisement for therapeutic goods containing any claim relating to weight management must balance the claims with the need for a healthy energy‑controlled diet and physical activity.

(2)                 Advertising of therapeutic goods containing any claim relating to weight management must not include any reference or depiction suggesting that the therapeutic goods will correct or reverse the effects of overeating or over‑consumption of any food or drink.

(3)                 An advertisement for therapeutic goods containing any claim relating to weight management must not:

(a)              feature individuals in images or visual representations; or

(b)     use individuals’ statistics or testimonials;

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.

(4)                 In this section:

weight management includes the following:

(a)              weight loss;

(b)     weight control;

(c)      weight maintenance;

(d)     measurement reduction;

(e)      clothing size reduction;

(f)      hunger suppression.

27 Sunscreens

(1)                 This section applies to an advertisement for a therapeutic good that is or contains a sunscreen that claims or implies that the good (the sunscreen) will prevent any of the following:

(a)      sunburn;

(b)     skin cancer.

(2)                 Advertising of sunscreens must:

(a)              depict sunscreens as being only one part of sun protection; and

(b)     include statements or visual representations, prominently displayed or communicated, to the effect that:

(i)     prolonged high-risk sun exposure should be avoided; and

(ii)   frequent re-application or use in accordance with directions is required for effective sun protection.

Part 4—Restricted representations and prohibited representations

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

(1)                 For the purposes of section 42DD of the Act, a form of a disease, condition, ailment or defect is a serious form if:

(a)              it is medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified health professional, except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or

                     (b)  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.

Note 1:       Section 42DD of the Act provides that a representation that refers to a serious form of a disease, condition, ailment or defect is a restricted representation.

Note 2:       Sections 42DF and 42DK of the Act provide for the Secretary to approve or permit the use of a restricted representation in certain circumstances.

Note 3:       See sections 42DL and 42DLB of the Act for offences and a civil penalty for advertising therapeutic goods, where the advertisement contains a restricted representation.

(2)                 Subsection (1) does not apply to the diseases mentioned in section 30.

29 Restricted representations—public interest criteria

                   For the purposes of paragraph 42DF(4)(c) of the Act, the public interest criteria are as follows:

(a)              whether the reference would be likely to take advantage of the vulnerability of consumers, or particular groups of consumers, when faced with the disease, condition, ailment or defect;

(b)     whether the reference would be likely to result in consumers not seeking timely professional medical advice where required (such as where that advice is important to prevent negative health consequences, morbidity or mortality, or deterioration or progression of the disease, condition, ailment or defect);

(c)      whether the reference would be likely (alone, through repetition or together with other references) to have a negative impact on public health (or to have an effect on persons other than those to whom the advertisement is directed);

(d)     such other aspects of the public interest as may appear to be appropriate to the Secretary.

30 Prohibited representations

                   For the purposes of paragraph 6B(1)(b) of the Regulations, the following representations are prohibited representations:

(a)      any representation regarding abortifacient action;

(b)     any representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to, the following diseases:

(i)     neoplastic disease;

(ii)   sexually transmitted diseases;

(iii) human immunodeficiency virus and acquired immune deficiency syndrome (HIV AIDS);

(iv) hepatitis C virus (HCV);

(v)   mental illness.

Note 1:       Subsection 42DJ(1) of the Act provides that representations of a kind specified in Regulations made for the purposes of that subsection are prohibited representations about therapeutic goods of a kind specified in those regulations. Subregulation 6B(1) of the Regulations provides that the representations mentioned in this instrument are prohibited representations.

Note 2:       Section 42DK of the Act provides for the Secretary to permit the use of a prohibited representation in certain circumstances.

Note 3:       See sections 42DL and 42DLB of the Act for offences and a civil penalty for advertising therapeutic goods, where the advertisement contains a prohibited representation.


 

Schedule 1—Medicine ingredients with specific health warnings

Note:              See section 4 (paragraph (a) of the definition of ‘health warnings’).

 

1 Table of medicine ingredients, circumstances and statements

The following Table lists ingredients, circumstances and statements for the purposes of paragraph (a) of the definition of ‘health warnings’ in section 4.

 

1. Ingredients        

 

2. Circumstances

3. Health Warning

 

Part 1: Statements for ingredient(s) in registered medicines

 

Aspartame

In preparations for oral use

Phenylketonurics -  product contains aspartame (phenylalanine)

Aspirin

 

In preparations for oral use

Do not use if you have a stomach ulcer, heart failure, are pregnant or allergic to anti-inflammatory medicines

 

Benzydamine

In preparations for topical use on mucosal surfaces, oral or dermal use

Do not use if you are allergic to benzydamine or other anti-inflammatory medicines

Butoconazole

In preparations for vaginal use

Do not use if pregnant

Chlorhexidine

In topical products including preparations for topical use on mucosal surfaces

Chlorhexidine can cause severe allergic reactions

Cold and Flu preparations containing the following:

·         Ammonia and ammonium salts, including:

o   ammonium chloride

o    ammonium bicarbonate

o   ammonium carbonate

·         Brompheniramine

·         Bromhexine

·         Clorphenamine (Chlorpheniramine)

·         Dexchlorpheniramine

·         Dextromethorphan

·         Dihydrocodeine

·         Diphenhydramine

·         Doxylamine

·         Guaifenesin (guaiphenesin)

·         Ipecacuanha

·         Oxymetazoline

·         Pentoxyverine

·         Pheniramine

·         Phenylephrine

·         Pholcodine

·         Promethazine

·         Pseudoephedrine

·         Senega

·         Triprolidine

·         Xylometazoline

1.      In preparations for oral use indicated for cough cold or flu which DO NOT include dosage instructions for children aged under 12 years OR includes dosage instructions for children aged ‘x’ to 11 years (where ‘x’ is 6,7,8,9,10 or 11)

 

2.      In nasal decongestant preparations for topical use indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years OR includes dosage instructions for children aged ‘x’ to 11 years (where ‘x’ is 6,7,8,9,10 or 11)

Either:

Do not give to children under 12 years of age

 

OR

 

Do not give to children under ‘x’ years of age.

Diphenoxylate

In preparations for oral use

Do not give to children under 12 years of age

 

Famciclovir

In medicines for oral use

Do not use if you have problems with your immune system or allergic to famciclovir or penciclovir

 

Fluconazole

In medicines for oral use

Do not use if pregnant

Fluorides (1of 2)

In liquid preparations for topical use and containing 1000mg/kg or more of fluoride ion

Do not use in children under 6 years

Fluorides (2 of 2)

In preparations as oral fluoride supplements

 

Do not use if pregnant

Hydroquinone

In preparations for topical use  

Do not use on children

Hydroxyanthracene derivatives such as those from:

·         Aloe

·         Buckthorn

·         Cascara

·         Frangula

·         Rhubarb

·         Senna

 

In preparations for oral use where the MRDD contains MORE than 10 mg

Do not use if you have  abdominal pain, nausea, vomiting or diarrhoea

Ibuprofen/ Paracetamol combinations 

 

In preparations  for oral use

 

Do not use if you have a stomach ulcer, impaired kidney function, heart failure, allergic to  anti-inflammatory medicines, pregnant or trying to become pregnant

 

Levocabastine

In topical eye or nasal preparations   

Do not use if pregnant

Loperamide

In preparations for oral use

Do not use if you have a condition where constipation should be avoided or give to

children under 12 years

 

Metoclopramide

In preparations for oral use

Do not use if you have epilepsy or give to children and adolescents under 18 years

 

Non-Steroidal Anti-inflammatory medicines:

·         Diclofenac

·         Flurbiprofen

·         Ibuprofen

·         Ketoprofen

·         Naproxen

·         Mefenamic acid

In preparations for oral use

Do not use if you have a stomach ulcer, impaired kidney function, heart failure, are allergic to anti-inflammatory medicines, or in the last 3 months of pregnancy

Phenylalanine

In preparations for oral use

Phenylketonurics -  this product contains phenylalanine

 

Promethazine

In preparations for oral use

Do not use if pregnant or breastfeeding

Tioconazole

In preparations for vaginal use

Do not use if pregnant

Vasoconstrictor eye drops:

·         Naphazoline

·         Oxymetazoline

·         Phenylephrine

·         Tetrahydrozoline

·         Tramazoline

·         Tymazoline

·         Xylometazoline

In topical eye preparations

Do not use if you have glaucoma or other serious eye conditions

 

Part 2: Statements for ingredient(s) in listed medicines

 

Actaea Racemosa including:

·         Black Cohosh Dry

·         Black Cohosh Powder

 

In preparations for oral use

Black Cohosh can harm the liver in some people

 

Aspartame

In preparations for oral use

Phenylketonurics -  product contains aspartame (phenylalanine)

Azadirachta Indica (neem)

In preparations for dermal use

Do not use if pregnant or likely to become pregnant

 

Carthamus Tinctorius

In preparations for oral use

Do not use if pregnant or likely to become pregnant

 

Chelidonium Majus

In preparations for oral use

Greater Celandine may harm the liver in some people

 

Fallopia Multiflora

In preparations for oral use

Fallopia multiflora may harm the liver in some people

 

Fluorides including:

·         Sodium Fluoride

·         Sodium Monofluorophosphate

In liquid preparations for topical use and containing 1000mg/kg or more of fluoride ion

 

Do not use in children under 6 years

Foeniculum Vulgare including:

·         Fennel Bitter Seed Dry

·         Fennel Oil

·         Fennel Sweet Seed Dry

In preparations for oral use

Do not use if pregnant, likely to become pregnant or breastfeeding  

Hydroxyanthracene derivatives including the following ingredients:

·         Aloe Ferox

·         Aloe Perryi

·         Aloe Vera

·         Aloes Cape

·         Cascara Dry

·         Cascara Powder

·         Cassia Fistula

·         Frangula Bark Dry

·         Frangula Bark Powder

·         Frangula Purshiana

·         Rhamnus Cathartica

·         Rhamnus Frangula

·         Rheum Officinale

·         Rheum Palmatum

·         Rheum Rhaponticum

·         Rheum Tanguticum

·         Rhubarb

·         Rhubarb Root Dry

·         Rhubard Root Powder

·         Senna Alexandrina

·         Senna Fruit Alexandrian Dry

·         Senna Fruit Alexandrian Powder

·         Senna Fruit Tinnevelly Dry

·         Senna Fruit Tinnevelly Powder

·         Senna Leaf Dry

·         Senna Leaf Powder

·         Senna Occidentalis

·         Senna Tora

In preparations for oral use where the MRDD contains MORE than 10 mg

Do not use if you have abdominal pain, nausea, vomiting or diarrhoea

 

Khaya Senegalensis

In preparations for oral use

Do not use if pregnant or likely to become pregnant

 

Larrea Tridentata

In preparations for oral use

Chaparral may harm the liver in some people

 

Methyl Salicylate including:

·         Betula Lenta

·         Betula Nigra

·         Betula Pendula

·         Birch Leaf Dry

·         Filipendula Ulmaria

·         Gaultheria Procumbens

·         Meadowsweet Herb

·         Nyctanthes Abortristis

·         Wintergreen oil

In preparations for topical use

Do not use if pregnant, likely to become pregnant or in children under 6 years

Phenylalanine

In preparations for oral use

Phenylketonurics -  this product contains phenylalanine

 

Piper Methysticum

In preparations for oral use and containing more than 25 mg of kavalactones (of Piper methysticum)

 

Kava may harm the liver in some people

Pollen

In preparations for oral use

 

Pollen can cause severe allergic reactions

 

Propolis  including:

·         Propolis Balsam

·         Propolis Dry Extract

·         Propolis LiquidExtract

·         Propolis Resin

·         Propolis Tincture

In preparations for oral use

 

Propolis can cause allergic reactions

Royal Jelly including:

·         Royal Jelly Fresh

·         Royal Jelly Lyophilised

In preparations for oral use

Can cause severe allergic reactions, do not use if you have asthma or allergies

 

Part 3: Statements for ingredients(s) in either registered or listed medicines

 

Aspartame

In preparations for oral use

Phenylketonurics -  product contains aspartame (phenylalanine)

Alpha Casozepine Enriched Hydrolysed Milk Protein

 

In preparations for oral use

 

Derived from cow's milk

Arachis including:

·         Arachis Hypogaea

·         Arachis Oil

·         Peanut

In all preparations

 

Contains Peanut

Avena including:

·         Avena Fatua

·         Avena Sativa

·         Oat

·         Oat Bran

·         Oatmeal Collodial

In preparations for oral use

 

Contains Gluten

Benzoates including:

·         Benzoic acid   

·         Sodium Benzoate

In all preparations

Contains benzoates

Or

Contains <insert name of benzoate used>

 

Bovine Colostrum Powder

In preparations for oral use

Contains cow's milk proteins and  lactose

 

Bovine Lactoferrin

In preparations for oral use

Derived from cow’s milk. 

 

Bovine Whey Ig-Rich Fraction

 

In preparations for oral use

 

Derived from cow’s milk. 

Calcium Sodium Caseinate

In preparations for oral use

Derived from cow’s milk

 

Canarium Indicum

In preparations for topical use

 

 

Derived from nuts

Euphausia Superba Oil

In preparations for oral use

Derived from seafood

 

Glucosamine  including:

·         Acetyl Glucosamine

·         Glucosamine  Hydrochloride

·         Glucosamine Sulfate

·         Glucosamine Sulfate Potassium Chloride

·         Glucosamine Sulfate Sodium Hydrochloride

 

In preparations for oral use and when derived seafood

Derived from seafood

Hydroxybenzoic acid esters including:

·         Ethyl hydroxybenzoate

·         Methyl hydroxybenzoate

·         Propyl hydroxybenzoate

·         Sodium Methyl hydroxybenzoate

·         Sodium Propyl hydroxybenzoate

In preparations for oral use

Contains Hydroxybenzoates

Or

Contains <insert name of Hydroxybenzoate used>

Hordeum including:

·         Hordeum Distichon

·         Hordeum  Vulgare

·         Barley

·         Barley Bran

·         Barley Germ

In preparations for oral use

 

Contains Gluten

Lactitol including:

·         Lactitol Monohydrate

In preparations for oral use

 

Derived from cow’s milk and contains lactose

Maltodextrin

In preparations for oral use and where ingredient is derived from gluten containing grains such as wheat, barley, rye and oats

 

Contains Gluten

Milk including:

·         Goat Milk

·         Nonfat Dry Milk

·         Whole Dry Milk

In preparations for oral use and contains Lactose

Contains Lactose

 

Phenylalanine

In preparations for oral use

Phenylketonurics -  this product contains phenylalanine

 

Poliglusam

In preparations for oral use

Derived from seafood

 

Secale including:

·         Secale Cereale

·         Rye

 

In preparations for oral use

 

Contains Gluten

Sorbic acid and Sorbic acid salts including:

·         Potassium Sorbate

In preparations for oral use

Contains Sorbates

OR

Contains <insert name of sorbate used>

 

Squid Oil including:

·         Concentrated Squid Omega-3 Triglycerides

In preparations for oral use

 

Derived from seafood

Lactose including:

·         Lactose Monohydrate

 

In preparations for oral use

Contains Lactose

Sulfite Salts including

·         Sodium Bisulfite

·         Sodium Metabisulfite

·         Sodium Sulfite

·         Sodium Bisulfite Heptahydrate

·         Sulfur Dioxide

 

In preparations for oral use

Contains Sulfites

OR

Contains <insert name of sulfite used>

Tartrazine

In preparation  for oral use

Contains Tartrazine

 

Triticum including:

·         Triticum Aestivum

·         Triticum Durum

·         Hydrolysed Wheat Protein

·         Pregelatinised Wheat Starch

·         Wheat

·         Wheat Bran

·         Wheat Dextrin

·         Wheat Germ

·         Wheat Germ Glycerides

·         Wheat Starch

In preparations for oral use

 

Contains Gluten

Whey including:

·         Whey powder

·         Whey protein

In preparations for oral use

Contains Lactose

Part 4: Statements for ingredients(s) in either registered or listed medicines on and after 1 September 2020

 

Egg, egg products including:

·         Egg Lecithin

·         Eggshell Membrane Hydrolysate

·         Eggshell Membrane Powder

In preparations for oral use

Contains Egg

Sesamum Indicum including:

·         Sesame Oil

·         Sesame Seed

In preparations for oral use

Contains Sesame

Soya beans and soya products including:

·         Glycine Max

·         Soya bean

·         Soya oil

excluding:

·         fully refined soya oil, vitamin e (such as d-alpha tocopherol) from soya bean sources,

·         phytosterols from soya bean sources

·          plant stanol esters from soya bean sources.

In preparations for oral use

Contains Soya

Tree nuts and tree nut products including:

·         Almond oil

·         Anarcardium Occidentale

·         Bertholletia Excelsa

·         Brazil Nut

·         Cashew

·         Castanea spp including:

o   Castanea Mollisima

o   Castanea Sativa

·         Chestnut Sweet

·         Corylus spp including:

o   Corylus Avellana

o   Corylus Americana

·         Hazelnut

·         Hazelnut Oil

·         Juglans spp including:

o   Juglans Cinerea

o   Juglans Nigra

o   Juglans Regia

·         Macadamia nut

·         Macadamia nut oil

·         Prunus dulcis

·         Semecarpus Anacardium

·         Walnut

·         Walnut Oil

In preparations for oral use

Contains Nut

 

 


 

 

Schedule 2—Advertising to children

Note:          See subsection 19(4).

1 Goods that may be advertised to children

For the purposes of section 19, the following therapeutic goods may be primarily advertised to children aged 12 years or over:

(a)      tampons;

(b)     acne preparations;

(c)      sunscreens SPF 15+;

(d)     condoms and personal lubricants;

(e)      bandages and dressings;

(f)      Class 1 medical devices for management of chronic conditions under medical supervision;

(g)      cold sore preparations;

(h)     lip balm;

(i)       unscheduled anti-dandruff preparations.

                         


 

Schedule 3—Samples

Note:          See section 20.

1 Goods that may be offered as samples

For the purposes of section 20, samples of the following therapeutic goods may be offered in advertisements:

(a)              condoms;

(b)     a therapeutic good that is or contains a sunscreen;

(c)      stoma devices for self-management;

(d)     continence catheter devices for self-management.

                         

 


 

Schedule 4—Price Information

 

Note:          See section 7.

1 Purpose

The purpose of this Schedule is to set out the conditions under which information about the price of prescription medicines and certain pharmacist‑only medicines may be provided to the general public.

2 Application

(1)                 This Schedule applies to all price information directed to consumers of therapeutic goods that consist of, or contain, substances included in Schedules 3, 4 or 8 to the current Poisons Standard, but not included in Appendix H to that Standard.

(2)                 Price information may not be provided for Pharmaceutical Benefits Scheme medicines supplied through alternative arrangements under section 100 of the National Health Act 1953, other than dispensing fees for buprenorphine hydrochloride and methadone hydrochloride.     

3 Who may provide price information

(1)                 Price information may only be provided by retail pharmacists, agents acting on behalf of retail pharmacists including pharmacy marketing groups, or dispensing doctors.

(2)                 Price information may not be provided by manufacturers, distributors or sponsors of medicines, other than pharmacy marketing groups acting in accordance with subclause (1).

4 Responsibility for compliance with this Schedule

(1)                 The following persons are responsible for ensuring compliance with this Schedule:

(a)              any person who publishes, by any means, price information for therapeutic goods to which this Schedule applies; or

(b)     any person who causes the publication, by any means, of price information for therapeutic goods to which this Schedule applies.

5 Methods for provision of price information

(1)                 Price information to which this Schedule applies may be provided by any method except:

(a)      transmission using radio or television; or

(b)     displays, including posters:

(i)     in shopping malls (except inside individual shops); and

(ii)   in or on public transport; and

(iii) on billboards; or

(c)              cinema advertising.

Online price information identified through a search function

(2)                 Where price information for the medicine is identified through a search function included in an electronic sales system, the results of the search must only include:

(a)              if the search is conducted using the name of the medicine or part thereof—a list of relevant medicines of that name;

(b)     if the search is conducted using an active ingredient or part thereof of the medicine—a list of relevant medicines in alphabetical order.

(3)                 The following provisions of this Schedule do not apply to price information identified in accordance with subclause (2):

(a)              subclause 6(1) and paragraph 6(3)(a);

(b)     clause 8;

(c)      clause 9.

6 General requirement restricting promotion

(1)                 Price information must not present or describe a medicine in a way that directs consumers to a particular medicine over and above any other medicine, whether or not that particular medicine is also referred to in the price information.

(2)                 Price information must not:

(a)              include or be presented with any promotional statement, picture or design; or

(b)     use:

(i)     adjectives or phrases that qualify the name of the medicine, sponsor’s pack size or formula of the medicine; or

(ii)   terms indicating the predicted or recommended length of supply; or

(c)              promote the purchase of quantities or multiple packs that are not approved sponsor pack sizes or multiples of those sizes, except as provided under clause 7 of this Schedule; or

(d)     use comparative adjectives or terms to qualify the price of the medicine; or

(e)      give any prominence to the text of the name, description or price of a medicine compared to the remainder of the price information text; or

(f)      offer rewards or bonus points, or be included in association with any other advertising that promotes rewards or bonus points; or

(g)      limit or qualify the availability of the price, other than by including a statement of validity or expiry of the price; or

(h)     include any embellishment; or

(i)       be accompanied by, or located in proximity to, information (including implications or references to other sources of information) regarding approved or unapproved indications, diseases, conditions, ailments or defects so that a reasonable person could infer that the medicine will cure or alleviate those diseases, conditions, ailments or defects.

(3)                 Price information must:

(a)              include at least 25 medicines; and

(b)     be accompanied by the names and contact details of the retail suppliers from whom the medicine referred to in that price information may be obtained at the listed price.

(4)                 Paragraph (3)(a) does not apply to price information for medicines mentioned in subclause 5(2) of this Schedule.

7 Description of medicines

(1)                 Medicines must be described in price information using the name of the medicine within the meaning of whichever is relevant to the medicine:

(a)              the Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines; or

(b)     the Therapeutic Goods Order No. 92 – Standard for labels of non‑prescription medicines.

(2)                 Price information must include, for each medicine:

(a)              if there is more than one strength of a form of the medicine—the strength of each active ingredient as it appears on the label of the medicine; and

(b)     the form in which the medicine is presented; and

(c)      the price for the relevant number of units of the sponsor’s standard pack; and

(d)     the quantity contained in the sponsor’s standard pack.

(3)                 For this section, the relevant number of units of the sponsor’s standard pack is:

(a)              if the Pharmaceutical Benefits Scheme or Repatriation Benefits Scheme permit more than one unit of the sponsor’s pack to be prescribed—the maximum number of units that may be prescribed under those schemes; and   

(b)     otherwise—one.     

(4)                 The need for a prescription for a particular medicine may also be indicated.

8 Presentation of price information

Alphabetical order

(1)                 Subject to subclause (2), medicines must be listed in alphabetical order by name, or by the names of active ingredients. Medicines must be set out in alphabetical order in each list according to only one of these classifications. More than one alphabetical list may be provided at the same time.

Medicine grouping

(2)                 Medicines may be grouped according to the Schedule in the current Poisons Standard in which they are included, provided that:

(a)              there are a sufficient number of medicines from each Schedule in each grouping so that consumers are not directed to a particular medicine over and above any other medicines; and

(b)     there are medicines from three or more sponsors included in the price information.

9 Pharmaceutical Benefits Scheme subsidised medicines

(1)                 Where a pharmacy marketing group publishes price information which includes both a Pharmaceutical Benefits Scheme subsidised medicine with a brand premium or therapeutic group premium and their own generic medicine, that information must include at least one other bench-mark price brand of that medicine in addition to their own medicine (where such products exist).

(2)                 Medicines subsidised under the Pharmaceutical Benefits Scheme must be identified and the total purchase price must be clearly specified as the general or concessional price. Both prices may be provided.

(3)                 Price lists which include a Pharmaceutical Benefits Scheme subsidised medicine must include an indication that the price is subsidised by the Australian Government, and only applies when prescribed for the medical conditions listed in the Pharmaceutical Benefits Scheme Schedule for that medicine.

(4)                 The price information may include a statement that specified medicines are subsidised under the Pharmaceutical Benefits Scheme only for a limited range of diseases, conditions, ailments or defects.

 


 

Schedule 5—Repeals

Note:          See section 6A.

Therapeutic Goods Advertising Code 2015

1  The whole of the instrument

Repeal the instrument

Therapeutic Goods Advertising Code 2018

2  The whole of the instrument

Repeal the instrument