Requirements

2021 Code

2018 Code

Mandatory Statements:

• The mandatory statements have been revised and are limited to direct-to-consumer advertising (DTC), where consumers cannot inspect the goods voluntarily before purchase.
• Additional mandatory statements have been included. For example:

1. Advertisement of pharmacist-only products, ‘ask your pharmacist about this product’ statement is mandatory.
2. Advertisement of therapeutic goods specific to HCP must include the statement, ‘this product is not available for purchase by the general public.’
3. Short form advertisements must include the ‘Always follow the directions for use' statement.

1. Medicines claiming to relate to a specific symptom of disease should include the mandatory statement, “If symptoms persist, worsen or change unexpectedly, talk to your healthcare professional.”
2. Advertisement of pharmacist-only medicine, “Ask your pharmacist – they must decide if this product is right for you.”
3. Direct/internet advertising of medicine must include,’ Always read the Label.’

The List of Product Samples:

Under Section 25 (Part 7), the 2021 Code expanded the list of samples that can be advertised. This list includes face masks and gloves, certain sanitary products, hand sanitizers, specific nicotine replacement therapies, and COVID-19 rapid antigen tests.

Included under Section 20 of the Code.

Advertisers cannot advertise their products with a sample except for products listed in Schedule 3.

The Rules for ‘Safe and Proper Use’ of Therapeutic Goods:

Advertisement must ensure that the therapeutic good represented:

• Is consistent with the directions or instructions for use for the product
• Does not overstate efficacy or performance of the good
• Does not lead consumers to use the goods inappropriately or excessively
• Eliminates the advertising, which causes alarms of fear and distress

Advertisement must ensure:

1. Proper use of medicine
2. Medicine doesn’t show delayed effect
3. Medicine doesn’t claim ‘cannot harm’
4. Medicine doesn’t mislead the consumers by stating it to be a miraculous, assured cure

Health Warnings:

Relevant warnings apply only on the direct purchase of drugs advertised, facilitating any purchase. These are applicable for physical and online purchases of therapeutic goods

Health warnings prescribed for medicines in Schedule 1 of the Code has been removed

The Testimonial and Endorsement Advertising Rules:

Section 24 (Part 6)

• consolidated testimonial requirements under section 24
• The 2021 Code clarifies the prohibition of paid or incentivized endorsement and testimonials

Sections 16 - Endorsement:

• Section 16(1)(b) is not applicable for non-prescription medicines
• Section 16(1)(a) is not applicable for Testimonial under s(17)

Section 17 - Testimonial

• Testimonial section is divided into three (03) sub-sections:
• s17(1) - Therapeutic good claim made by a person using the medicine
• s17(2)(a) - Characteristics of a person
• s17(2)(b)(c) - Obligation of the testimonial before being advertised
• s17(3) - Information disclosed in the ad about the testimonial

The Definition:

Includes modified information for the active ingredient, use, health warnings, price

Includes health warnings, prominently displayed, or communicated statements