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Mandatory statements and product details

12 November 2020

Medicines, devices and other therapeutic goods require particular statements and product details to be included in advertising, which provide information about the product, warnings about the product's use and guidance for consumers to seek assistance if required.

This section does not apply to medicine price lists produced by retail pharmacists that only include the name, image, price or point of sale details of the goods without any claims relating to therapeutic use.

Our decision tree can help you navigate the complex requirements for advertisers in this area.

Decision tree - What information do I need to include in advertising for therapeutic goods?

These same requirements are also set out in full detail below.

Pharmacist-only medicines

Ads for products containing pharmacist-only medicine - that is, with ingredients listed in both Schedule 3 and Appendix H of the Poisons Standard - must include the statement:

  • ASK YOUR PHARMACIST - THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU.

Statements including 'ALWAYS READ THE LABEL' and 'FOLLOW THE DIRECTIONS FOR USE' that are required for advertising other medicines are not required for pharmacist-only medicines.

For details refer to Section 11 of the Code.

Pharmacy and other medicines

For all medicines other than pharmacist-only medicines, the requirements to include product information and statements in advertising will vary depending on the ingredients, method of use and ability for the consumer to examine it when purchasing.

For details refer to Sections 12, 13 and 24 of the Code and Part 2 of Schedule 2 of the Regulations.

Product details

At a minimum, an ad for a medicine must include:

  • The name of the medicine
  • At least one of the indications as it appears on the product label.

If it promotes purchase in a way that would not allow consumers to physically examine the product when purchasing, it must also include:

  • Dosage information
  • Quantity of items included in the package
  • A list of ingredients.

General statements

All must include the statement:

  • FOLLOW THE DIRECTIONS FOR USE.

If the product contains an analgesic, the ad must include the statement:

  • INCORRECT USE COULD BE HARMFUL.

Retail product labels for vitamin supplements taken orally must include a statement that:

  1. VITAMINS CAN ONLY BE OF ASSISTANCE IF THE DIETARY VITAMIN INTAKE IS INADEQUATE; or
  2. VITAMIN SUPPLEMENTS SHOULD NOT REPLACE A BALANCED DIET

Ads for medicines including claims relating to a disease, ailment, condition or defect must include one of the following statements, as appropriate to the duration or recurrence of the symptoms:

  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.

No health warning

Ads for medicines that don't require a health warning must include the statement:

  • ALWAYS READ THE LABEL.

Health warning

Medicine ingredients that attract a health warning and the relevant warning statements are detailed in Schedule 1 of the Code.

Ads for medicines that require a health warning must include prescribed warning statements*.

If the ad promotes purchase in a way that would not allow consumers to physically examine the product when purchasing, it must include one of the following statements:

  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; or
  2. ALWAYS READ THE LABEL and the health warnings for the specified medicine.

If consumers are able to physically examine the product when purchasing, the ad must include one of the following statements.

For an advertisement for a single medicine, 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 specified medicine.

For an advertisement for multiple medicines where at least one has a health warning, you can choose to use the following statement:

  • THESE MEDICINES MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE

* Exceptions include radio ads of 15 seconds or less or text only ads of 300 characters or less that are unable to include graphics or imagery within the ad.

Medical devices and other therapeutic goods

Different statement combinations are required depending on the risks associated with the goods and ability for the consumer to examine it when purchasing.

For details refer to Sections 12 and 13 of the Code.

Product details

At a minimum, an ad for a device or other therapeutic good must include:

  • The product's trade name or other accepted name
  • An accurate description of the product
  • At least one of the indications as it appears on the product label or packaging.

If it promotes purchase in a way that would not allow consumers to physically examine the product when purchasing, it must also include a list of ingredients, where relevant.

General statements

All must include one of the following statements:

  1. FOLLOW THE DIRECTIONS FOR USE
  2. FOLLOW THE INSTRUCTIONS FOR USE.

If the product contains an analgesic, the ad must include the statement:

  • INCORRECT USE COULD BE HARMFUL.

Ads for devices and other therapeutic goods including claims relating to a disease, ailment, condition or defect must include one of the following statements, as appropriate to the duration or recurrence of the symptoms:

  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.

No health warning

Ads for devices and other therapeutic goods that don't require a health warning to be communicated must include one of the following statements as appropriate to the product's packaging:

  1. ALWAYS READ THE LABEL; or
  2. ALWAYS READ THE INSTRUCTIONS FOR USE.

Health warning

Devices and other therapeutic goods which require a health warning are those which have identified risks associated with using the product as intended where someone:

  • May die, require hospitalisation or medical attention to treat or prevent an injury, disability or incapacity.
  • With a serious form of disease or condition, with an implantable device, of a specific class of persons or is pregnant should not use the device.

These will be detailed on the product's label or instructions for use, as required under the Therapeutic Goods (Medical Devices) Regulations.

Ads for devices and other therapeutic goods that require a health warning must include prescribed warning statements*.

If the ad promotes purchase in a way that would not allow consumers to physically examine the product when purchasing, it must include one of the following statements:

  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 specified product; or
  3. ALWAYS READ THE INSTRUCTIONS FOR USE and the health warnings for the specified product.

If consumers are able to physically examine the product when purchasing, the ad must include one of the following statements:

  • 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; or
    2. ALWAYS READ THE LABEL and the health warnings for the specified product.
  • 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 specified product.

* Exceptions include radio ads of 15 seconds or less or text only ads of 300 characters or less that are unable to include graphics or imagery within the ad.