Mandatory information required in advertising for therapeutic goods

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Scheduling is a national classification system that controls how medicines and poisons are made available to the public. Medicines and poisons are classified into Schedules according to the level of regulatory control over the availability of the medicine or poison required to protect public health and safety. The schedule applied to a product impacts on whether it can be advertised to the public and, if it can, the information that needs to be included in the advertising.

To establish whether the product being advertised is, or contains, a Schedule 3 substance:

• Does the packaging have a prominent statement on the front stating it is a “Pharmacist Only Medicine”? If so, it is a Schedule 3 substance.
• You can also confirm whether the product is in Schedule 3 by checking the ingredients against the Poisons Standard.

It is possible for a medical device to contain a schedule 3 substance.

The TGA classifies therapeutic goods as:

• Medicines (prescription, over-the-counter and complementary)
• Biologicals
• Medical devices (including in vitro diagnostic devices like pregnancy and ovulation tests), or
• Other therapeutic goods (namely, disinfectants, sterilants, tampons and menstrual cups).

The advertising requirements for each classification of good can vary. For example, biologicals and prescription medicines cannot be advertised to the public at all. Advertising for some medicines will need to include additional information over and above that required for other medicines.

Therapeutic goods, with the exception of some exempt goods like certain homoeopathic medicines and disinfectants, must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be commercially supplied.

Note that there can be overlap between different types of medicines. Medicines may be registered or listed in the ARTG or exempt from this requirement. Over-the-counter medicines (that is medicines that do not require a prescription for supply) may be either registered or listed. Complementary medicines may be registered, listed or exempt. For registered and listed medicines, you can check the ARTG number displayed on the front of medicines packaging against the ARTG on the TGA website to assist you in working out whether it is a prescription, over-the-counter or complementary medicine. For medical devices, you may need to check with the supplier to obtain the ARTG number.

For advertising of exempt medicines, you should select the option “OTC or complementary medicine” below. The advertising of exempt medicines must still comply with the advertising requirements in the Code for OTC medicines and complementary medicines.

Certain types of therapeutic goods cannot be advertised to the public. These include:

• Prescription medicines (i.e. medicines in Schedule 4 or 8 of the Poisons Standard)
• Pharmacist only medicines that are not entered in Appendix H of the Poisons Standard
• Biologicals.

If you are unsure what type of therapeutic good the product you want to advertise to the public is, you can:

• Check the ARTG
• Contact the TGA.

Other useful information

• Advertising basics, general information and enquiries
• Decision tree: Can I advertise this therapeutic good to the public?
• Therapeutic goods legislation and advertising

Some advertisements enable consumers to purchase a therapeutic good without being able to inspect it. For example, online stores, mail order catalogues and call centres all facilitate the purchase of a good without prior inspection. In this decision tree, we refer to this as “direct marketing”.

As the consumer can purchase the good via the advertisement without inspecting it beforehand, it is important that they receive a greater level of information about it. So the requirements for these advertisements are a bit different to other types of advertisements.

To assess whether there is a health warning for the OTG to be advertised, you will need to review:

• the label and/or packaging for the OTG, and
• any instructions for use included with the OTG.

Look for any statements that:

• warn that a person who takes or uses the OTG as intended may:
  • die; or
  • require hospitalisation or a longer period of hospitalisation than would be required if the person had not taken or used the goods; or
  • require a medical practitioner to treat or prevent injury, disability or incapacity as a consequence of taking or using the goods
• indicate the OTG should not be taken or used:
  • by people with a serious form (as defined in section 28 of the Code) of a disease, condition, ailment, or defect
  • by people with certain types of implantable device(s)
  • in pregnancy, or
  • by a specific class of people.

If you identify one or more such statements, the OTG is considered to have health warnings for the purposes of the Code.

(Refer to the definition of ‘health warning’ in section 4 of the Code.)

You must include the following information in the advertisement:

1. An accurate description of the goods (subsection 13(4)(a) of the Code)
2. Either (subsection 13(4)(b) of the Code):
   1. The trade name of the goods (if available), or
   2. Another name for the goods
3. At least one of the intended purposes or indications shown on the label or primary packaging for the OTG – this can be word-for-word as it appears on the label/packaging or different wording can be used provided it does not change the meaning or intent of the indication shown on the label or packaging (subsection 13(4)(c) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. One of the following (subsection 13(4)(d) of the Code):
   1. “ALWAYS READ THE LABEL”, or
   2. “ALWAYS READ THE INSTRUCTIONS FOR USE”, as appropriate for the labelling and packaging of the goods

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(5) of the Code)

1. Either “FOLLOW THE DIRECTIONS FOR USE” or “FOLLOW THE INSTRUCTIONS FOR USE”, as appropriate for the good being advertised (subsection 13(6) of the Code)
2. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements, as appropriate to the duration or recurrence of the symptoms (ss.13(7) and (7A) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(8) of the Code).

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What advertisements must contain - general rules
• Q&A: How do I include mandatory statements (including health warnings) in catalogues where I have limited room but need to ensure that they are prominently displayed?

You must include the following information in the advertisement:

1. An accurate description of the goods (subsection 13(4)(a) of the Code)
2. Either (subsection 13(4)(b) of the Code):
   1. The trade name of the goods (if available), or
   2. Another name for the goods
3. At least one of the intended purposes or indications shown on the label or primary packaging for the OTG – this can be word-for-word as it appears on the label/packaging or different wording can be used provided it does not change the meaning or intent of the indication shown on the label or packaging (subsection 13(4)(c) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. One of the following (subsection 13(4)(d) of the Code):
   • Where the label of the goods is visible on the primary pack, one of the following:
     1. “THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE”
     2. “ALWAYS READ THE LABEL” and the health warnings for the goods
   • Where the goods do 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”, or
     2. “ALWAYS READ THE INSTRUCTIONS FOR USE” and the health warnings for the goods

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(5) of the Code)

1. Either “FOLLOW THE DIRECTIONS FOR USE” or “FOLLOW THE INSTRUCTIONS FOR USE”, as appropriate for the good being advertised (subsection 13(6) of the Code)
2. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements, as appropriate to the duration or recurrence of the symptoms (ss.13(7) and (7A) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(8) of the Code).

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What advertisements must contain - general rules
• Q&A: How do I include mandatory statements (including health warnings) in catalogues where I have limited room but need to ensure that they are prominently displayed?

To assess whether there is a health warning for the other therapeutic good (OTG) to be advertised, you will need to review:

• the label and/or packaging for the OTG, and
• any instructions for use included with the OTG.

Look for any statements that:

• warn that a person who takes or uses the OTG as intended may:
  • die; or
  • require hospitalisation or a longer period of hospitalisation than would be required if the person had not taken or used the goods; or
  • require a medical practitioner to treat or prevent injury, disability or incapacity as a consequence of taking or using the goods
• indicate the OTG should not be taken or used:
  • by people with a serious form (as defined in section 28 of the Code) of a disease, condition, ailment, or defect
  • by people with certain types of implantable device(s)
  • in pregnancy, or
  • by a specific class of people.

If you identify one or more such statements, the OTG is considered to have health warnings for the purposes of the Code.

(Refer to the definition of ‘health warning’ in section 4 of the Code.)

You must include the following information in the advertisement:

1. An accurate description of the goods (subsection 12(5)(a) of the Code)
2. Either (subsection 12(5)(b) of the Code):
   1. The trade name of the goods (if available), or
   2. Another name for the goods
3. At least one of the intended purposes or indications shown on the label or primary packaging for the OTG – this can be word-for-word as it appears on the label/packaging or different wording can be used provided it does not change the meaning or intent of the indication shown on the label or packaging (subsection 12(5)(c) of the Code)
4. A list of the ingredients, where the goods consist of, or contain, substances (subsection 12(5)(d) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. One of the following, as appropriate for the packaging of the goods (subsection 12(5)(e) of the Code):
   1. “ALWAYS READ THE LABEL”, or
   2. “ALWAYS READ THE INSTRUCTIONS FOR USE”
2. Either “FOLLOW THE DIRECTIONS FOR USE” or “FOLLOW THE INSTRUCTIONS FOR USE”, as appropriate for the good being advertised (subsection 12(5)(f) of the Code)
3. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements, as appropriate to the duration or recurrence of the symptoms (ss.12(5)(g) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL.

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What must advertisements contain - goods that are not available for physical examination before purchase

You must include the following information in the advertisement:

1. An accurate description of the goods (subsection 12(5)(a) of the Code)
2. Either (subsection 12(5)(b) of the Code):
   1. The trade name of the goods (if available), or
   2. Another name for the goods
3. At least one of the intended purposes or indications shown on the label or primary packaging for the OTG – this can be word-for-word as it appears on the label/packaging or different wording can be used provided it does not change the meaning or intent of the indication shown on the label or packaging (subsection 12(5)(c) of the Code)
4. A list of the ingredients, where the goods consist of, or contain, substances (subsection 12(5)(d) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. One of the following (subsection 12(5)(e) of the Code):
   1. “THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE”, followed immediately by information about where the health warnings can be found
   2. “ALWAYS READ THE LABEL” and the health warnings for the OTG, or
   3. “ALWAYS READ THE INSTRUCTIONS FOR USE” and the health warnings for the OTG
2. Either “FOLLOW THE DIRECTIONS FOR USE” or “FOLLOW THE INSTRUCTIONS FOR USE”, as appropriate for the good being advertised (subsection 12(5)(f) of the Code)
3. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements, as appropriate to the duration or recurrence of the symptoms (ss.12(5)(g) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL.

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What must advertisements contain - goods that are not available for physical examination before purchase

Some advertisements enable consumers to purchase a device without being able to inspect it. For example, online stores, mail order catalogues and call centres all facilitate the purchase of goods without prior inspection. In this decision tree, we refer to this as “direct marketing”.

As the consumer will purchase the device without inspecting it beforehand, it is important that they receive a greater level of information about the device in the advertisement. So the requirements for these advertisements are different to other types of advertisements.

To assess whether there is a health warning for the device to be advertised, you will need to review:

• the label and/or packaging for the device, and
• any instructions for use included with the device.

Look for any statements that:

• warn that a person who takes or uses the device as intended may:
  • die; or
  • 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
  • require a medical practitioner to treat or prevent injury, disability or incapacity as a consequence of taking or using the device or goods
• indicate the device should not be taken or used:
  • by people with a serious form (as defined in section 28 of the Code) of a disease, condition, ailment, or defect
  • by people with certain types of implantable device(s)
  • in pregnancy, or
  • by a specific class of people.

If you identify one or more such statements, the device is considered to have health warnings for the purposes of the Code.

(Refer to the definition of ‘health warning’ in section 4 of the Code.)

You must include the following information in the advertisement:

1. An accurate description of the device (subsection 13(3)(a) of the Code)
2. Either (subsection 13(3)(b) of the Code):
   1. The trade name of the device (if available), or
   2. Another name for the device
3. At least one of the intended purposes, or indications, shown on the label or primary packaging for the device – this can be word-for-word as it appears on the label/packaging or different wording can be used provided it does not change the meaning or intent of the purpose/indication shown on the label or packaging (subsection 13(3)(c) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. One of the following - as appropriate for the packaging of the device (subsection 13(3)(d) of the Code):
   1. “ALWAYS READ THE LABEL”, or
   2. “ALWAYS READ THE INSTRUCTIONS FOR USE”

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(5) of the Code)

1. Either “FOLLOW THE DIRECTIONS FOR USE” or “FOLLOW THE INSTRUCTIONS FOR USE”, as appropriate for the device being advertised (subsection 13(6) of the Code)
2. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements, as appropriate to the duration or recurrence of the symptoms (ss.13(7) and (7A) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(8) of the Code).

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What advertisements must contain - general rules
• Q&A: How do I include mandatory statements (including health warnings) in catalogues where I have limited room but need to ensure that they are prominently displayed?

You must include the following information in the advertisement:

1. An accurate description of the device (subsection 13(3)(a) of the Code)
2. Either (subsection 13(3)(b) of the Code):
   1. The trade name of the device (if available), or
   2. Another name for the device
3. At least one of the intended purposes, or indications, shown on the label or primary packaging for the device – this can be word-for-word as it appears on the label/packaging or different wording can be used provided it does not change the meaning or intent of the purpose/indication shown on the label or packaging (subsection 13(3)(c) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. One of the following statements (subsection 13(3)(d) of the Code):
   • Where the device label is visible on the primary pack, either:
     1. “THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE”, followed immediately by information about where the health warnings can be found
     2. “ALWAYS READ THE LABEL” and the health warnings for the medical device
   • Where the device does not have a label visible on the primary pack, either:
     1. “THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE INSTRUCTIONS FOR USE BEFORE PURCHASE”, or
     2. “ALWAYS READ THE INSTRUCTIONS FOR USE” and the health warnings for the medical device

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(5) of the Code)

1. Either “FOLLOW THE DIRECTIONS FOR USE” or “FOLLOW THE INSTRUCTIONS FOR USE”, as appropriate for the device being advertised (subsection 13(6) of the Code)
2. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements, as appropriate to the duration or recurrence of the symptoms (ss.13(7) and (7A) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(8) of the Code).

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What advertisements must contain - general rules
• Q&A: How do I include mandatory statements (including health warnings) in catalogues where I have limited room but need to ensure that they are prominently displayed?

To assess whether there is a health warning for the device to be advertised, you will need to review:

• the label and/or packaging for the device, and
• any instructions for use included with the device.

Look for any statements that:

• warn that a person who takes or uses the device as intended may:
  • die; or
  • 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
  • require a medical practitioner to treat or prevent injury, disability or incapacity as a consequence of taking or using the device or goods
• indicate the device should not be taken or used:
  • by people with a serious form (as defined in section 28 of the Code) of a disease, condition, ailment, or defect
  • by people with certain types of implantable device(s)
  • in pregnancy, or
  • by a specific class of people.

If you identify one or more such statements, the device is considered to have health warnings for the purposes of the Code.

(Refer to the definition of ‘health warning’ in section 4 of the Code.)

You must include the following information in the advertisement:

1. An accurate description of the device (subsection 12(4)(a) of the Code)
2. Either (subsection 12(4)(b) of the Code):
   1. The trade name of the device (if available), or
   2. Another name for the device
3. At least one of the intended purposes, or indications, shown on the label or primary packaging for the device – this can be word-for-word as it appears on the label/packaging or different wording can be used provided it does not change the meaning or intent of the purpose/indication shown on the label or packaging (subsection 12(4)(c) of the Code)
4. A list of the ingredients, where the device consists of, or contains, substances (subsection 12(4)(d) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. One of the following (subsection 12(4)(e) of the Code):
   1. “ALWAYS READ THE LABEL”, or
   2. “ALWAYS READ THE INSTRUCTIONS FOR USE”
2. Either “FOLLOW THE DIRECTIONS FOR USE” or “FOLLOW THE INSTRUCTIONS FOR USE”, as appropriate for the device being advertised (subsection 12(4)(f) of the Code)
3. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements, as appropriate to the duration or recurrence of the symptoms (ss.12(4)(g) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL.

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What must advertisements contain - goods that are not available for physical examination before purchase

You must include the following information in the advertisement:

1. An accurate description of the device (subsection 12(4)(a) of the Code)
2. Either (subsection 12(4)(b) of the Code):
   1. The trade name of the device (if available), or
   2. Another name for the device
3. At least one of the intended purposes, or indications, shown on the label or primary packaging for the device – this can be word-for-word as it appears on the label/packaging or different wording can be used provided it does not change the meaning or intent of the purpose/indication shown on the label or packaging (subsection 12(4)(c) of the Code)
4. A list of the ingredients, where the device consists of, or contains, substances (subsection 12(4)(d) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. One of the following (subsection 12(4)(e) of the Code):
   1. “THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE”, followed immediately by information about where the health warnings can be found, or
   2. “ALWAYS READ THE LABEL” and the health warnings for the medical device, or
   3. “ALWAYS READ THE INSTRUCTIONS FOR USE” and the health warnings for the medical device
2. Either “FOLLOW THE DIRECTIONS FOR USE” or “FOLLOW THE INSTRUCTIONS FOR USE”, as appropriate for the device being advertised (subsection 12(4)(f) of the Code)
3. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements, as appropriate to the duration or recurrence of the symptoms (ss.12(4)(g) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL.

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What must advertisements contain - goods that are not available for physical examination before purchase

Some advertisements enable consumers to purchase a medicine without being able to inspect it. For example, online stores, mail order catalogues and call centres all facilitate the purchase of goods without prior inspection. In this decision tree, we refer to this as “direct marketing”.

As the consumer will purchase the medicine without inspecting it – and the label - beforehand, it is important that they receive a greater level of information about the medicine in the advertisement. So the requirements for these advertisements are different to other types of advertisements.

To determine if the medicine to be advertised has a health warning:

• Identify the ingredients in the medicine from the label of the medicine – you will need to look for both active ingredients and other ingredients that may be specified on the back of the packaging.
• For listed medicines, check each of the ingredients against Part 2 of Schedule 1 of the Code to see if a health warning is listed.
• For all other medicines, check each of the ingredients against Part 1 of Schedule 1 of the Code to see if a health warning is listed.

You must include the following information in the advertisement:

1. The name of the medicine (subsection 13(2)(a) of the Code)
2. At least one of the indications shown on the medicine label – this can be word-for-word as it appears on the label or different wording can be used provided it does not change the meaning or intent of the indication shown on the label (subsection 13(2)(b) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. ALWAYS READ THE LABEL (see subsection 13(2)(c) of the Code)

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(5) of the Code)

1. FOLLOW THE DIRECTIONS FOR USE (see subsection 13(6) of the Code)
2. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements as appropriate to the duration or recurrence of the symptoms (ss.13(7) and (7A) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(8) of the Code)

1. For a complementary medicine that will be advertised with one or more claims based on evidence of a history of traditional use, the traditional use and paradigm must be disclosed (section 23 of the Code)
2. If the medicine is an analgesic (see definition in section 4 of the Code) – INCORRECT USE COULD BE HARMFUL (section 24 of the Code)
3. If the medicine is a sunscreen – messages to the effect that (section 27 of the Code):
   1. prolonged high-risk sun exposure should be avoided; and
   2. frequent re-application or use in accordance with directions is required for effective sun protection.

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What advertisements must contain - general rules
• Q&A: What is the 'name of the medicine' that must be included in advertising?
• Q&A: How do I include mandatory statements (including health warnings) in catalogues where I have limited room but need to ensure that they are prominently displayed?

You must include the following information in the advertisement:

1. The name of the medicine (subsection 13(2)(a) of the Code)
2. At least one of the indications shown on the medicine label – this can be word-for-word as it appears on the label or different wording can be used provided it does not change the meaning or intent of the indication shown on the label (subsection 13(2)(b) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. Either (see subsection 13(2)(c) of the Code):
   • For an advertisement for a single medicine (see subsection 13(2)(c) of the Code), include:
     1. THIS MEDICINE MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE, or
     2. ALWAYS READ THE LABEL and the health warnings for the medicine from Schedule 1 of the Code
   • For an advertisement for multiple medicines, where at least one has a health warning, (see subsection 13(2A) of the Code, rather than using one of the above statements for each medicine, you can choose to use the following instead:
     • THESE MEDICINES MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(5) of the Code)

1. FOLLOW THE DIRECTIONS FOR USE (see subsection 13(6) of the Code)
2. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements as appropriate to the duration or recurrence of the symptoms (ss.13(7) and (7A) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL;
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL

NOTE: Radio advertisements that are 15 seconds or less in duration and text-only advertisements of 300 characters or less, for which there is no capacity to include pictures, are exempt from this requirement (see subsection 13(8) of the Code)

1. For a complementary medicine that will be advertised with one or more claims based on evidence of a history of traditional use, the traditional use and paradigm must be disclosed (section 23 of the Code)
2. If the medicine is an analgesic (see definition in section 4 of the Code) – INCORRECT USE COULD BE HARMFUL (section 24 of the Code)
3. If the medicine is a sunscreen– messages to the effect that (section 27 of the Code):
   1. prolonged high-risk sun exposure should be avoided; and
   2. frequent re-application or use in accordance with directions is required for effective sun protection.

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What advertisements must contain - general rules
• Q&A: What is the 'name of the medicine' that must be included in advertising?
• Q&A: How do I include mandatory statements (including health warnings) in catalogues where I have limited room but need to ensure that they are prominently displayed?

To determine if the medicine to be advertised has a health warning:

• Identify the active ingredients in the medicine.
• Identify any other relevant ingredients in the medicine (e.g. lactose, gluten, pollen).
• For listed medicines, check each of the ingredients against Parts 2 and 3 of Schedule 1 of the Code to see if a health warning is present.
• For all other medicines, check each of the ingredients against Parts 1 and 3 of Schedule 1 of the Code to see if a health warning is present.

You must include the following information in the advertisement:

1. The name of the medicine (ss.12(3)(a) of the Code)
2. The dosage form (ss.12(3)(b) of the Code)
3. The quantity of the medicine (ss.12(3)(c) of the Code)
4. At least one of the indications shown on the medicine label – this can be word-for-word as it appears on the label or different wording can be used provided it does not change the meaning or intent of the indication shown on the label (ss.12(3)(d) of the Code)
5. A list of the ingredients (ss.12(3)(e) of the Code) – see section 4 of the Code for the definition of ‘ingredients’.

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. “ALWAYS READ THE LABEL” (subsection 12(3)(f) of the Code)
2. “FOLLOW THE DIRECTIONS FOR USE” (subsection 12(3)(g) of the Code)
3. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements as appropriate to the duration or recurrence of the symptoms (subsection 12(3)(h) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL; or
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL
4. For a complementary medicine that will be advertised with one or more claims based on evidence of a history of traditional use, the traditional use and paradigm must be disclosed (s.23 of the Code)
5. If the medicine is an analgesic (see definition in section 4 of the Code) – “INCORRECT USE COULD BE HARMFUL” (section 24 of the Code)
6. If the medicine is a sunscreen – messages to the effect that (section 27 of the Code):
   1. prolonged high-risk sun exposure should be avoided; and
   2. frequent re-application or use in accordance with directions is required for effective sun protection.

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• What must advertisements contain - goods that are not available for physical examination before purchase
• Q&A: What is the 'name of the medicine' that must be included in advertising?

You must include the following information in the advertisement:

1. The name of the medicine (ss.12(3)(a) of the Code)
2. The dosage form (ss.12(3)(b) of the Code)
3. The quantity of the medicine (ss.12(3)(c) of the Code)
4. At least one of the indications shown on the medicine label – this can be word-for-word as it appears on the label or different wording can be used provided it does not change the meaning or intent of the indication shown on the label (ss.12(3)(d) of the Code)
5. A list of the ingredients – both actives and any excipients that require identification under the labelling order (ss.12(3)(e) of the Code).

In addition, the following information must be prominently displayed or communicated in the advertisement:

1. Either (ss.12(3)(f) of the Code):
   1. “THIS MEDICINE MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE”, followed immediately by information about where the health warnings can be found
   2. “ALWAYS READ THE LABEL” and the health warnings for the medicine from Schedule 1 of the Code
2. “FOLLOW THE DIRECTIONS FOR USE” (ss.12(3)(g) of the Code)
3. If the advertisement contains a claim relating to a symptom of a disease, condition, ailment or defect, the advertisement must contain one of the following statements as appropriate to the duration or recurrence of the symptoms (ss.12(3)(h) of the Code):
   1. IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL; or
   2. IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL
   3. IF SYMPTOMS PERSIST, WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL
4. For a complementary medicine that will be advertised with one or more claims based on evidence of a history of traditional use, the traditional use and paradigm must be disclosed (s.23 of the Code)
5. If the medicine is an analgesic (see definition in section 4 of the Code) – “INCORRECT USE COULD BE HARMFUL” must be shown (s.24 of the Code)
6. If the medicine is a sunscreen – messages to the effect that (s.27 of the Code):
   1. prolonged high-risk sun exposure should be avoided; and
   2. frequent re-application or use in accordance with directions is required for effective sun protection.

If you have one or more of the following in your advertisement, you may also need to include additional information:

1. If the advertisement includes a citation to clinical or scientific literature (including implied citations like “clinically proven to …”), the advertisement must provide additional information about the study or research (see subsection 15(3) of the Code)
2. Using an endorsement from certain types of individuals or organisations in advertising requires additional information about the nature of the endorsement to be included in the advertising (see subsection 16(3) of the Code)
3. In certain situations, advertising that includes testimonials must include additional information about the nature of the testimonial (see subsection 17(3) of the Code).

Not all Schedule 3 substances can be advertised to the public – only those listed in Appendix H of the Poisons Standard can be advertised to the public.

Further information about Appendix H, and the possible reasons why a Schedule 3 medicine has not been included in it are available on the TGA website.

Not all Schedule 3 (pharmacist only) medicines can be advertised to the public. Only those Schedule 3 medicines listed in Appendix H of the Poisons Standard can be advertised to consumers.

However, for Schedule 3 medicines that are not in Appendix H, pharmacies can provide price information. See Schedule 4 of the Code and the corresponding guidance for more information.

Other useful information

• Advertising basics, general information and enquiries
• Decision tree: Can I advertise this therapeutic good to the public?
• Therapeutic goods legislation and advertising

The advertisement must prominently display or communicate the following information prescribed by the Advertising Code for Schedule 3 substances:

• “ASK YOUR PHARMACIST—THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU” (section 11 of the Code), and
• if the medicine is also an analgesic (as defined in section 4 of the Code) - “INCORRECT USE COULD BE HARMFUL” (section 24 of the Code).

This requirement applies to all types of advertisements for Schedule 3 substances that are entered in Appendix H of the Poisons Standard.

These are the minimum information requirements for the advertisement. You can include additional information about the product in the advertisement if you wish.

Other useful information

• Advertising basics, general information and enquiries
• Therapeutic goods legislation and advertising
• Pharmacist-only medicines (required statement)
• Q&A: How do I include mandatory statements (including health warnings) in catalogues where I have limited room but need to ensure that they are prominently displayed?

The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials.

The decision tree will provide you with the minimum set of information required in your advertisement under the Code, based on the type of therapeutic good and the type of advertisement. You can include additional information in the advertisement if you wish, provided the minimum requirements are met.

Note that compliance with the minimum information requirements does not guarantee that your advertisement will fully comply with the Code and the advertising legislation more broadly. You will still need to review your advertising for compliance with all other relevant requirements in the Therapeutic Goods Act 1989 (the Act) and the Code.

Also note that under the Act and Code requirements, representations that refer to serious forms of a disease, condition, ailment or defect are restricted representations and prior approval from the TGA will be required before you advertise the goods.