Australia's TGA Guidance Blog: Labelling and Presentation Requirements for Listed Medicines

On 9 April 2025, the Therapeutic Goods Administration (TGA) released updated guidance titled “Understanding Labelling and Presentation Requirements for Listed Medicines”. This document provides comprehensive insights into the acceptable and unacceptable presentations of listed medicines, specifics of listed medicine labels, TGA's assessment criteria, naming conventions, and labelling requirements for specific ingredients and medicines.

Listed Medicines: Medicines included in the Australian Register of Therapeutic Goods (ARTG) based on self-assessment by sponsors, asserting compliance with all regulatory requirements.

Unacceptable Presentation: Defined under Section 3(5) of the Act, it includes presentations that are misleading or confusing regarding the content, proper use, or identification of the goods.

This guideline aims to:

1. Ensure listed medicines are presented truthfully and accurately to consumers.

2. Prevent misleading claims or designs that could imply unapproved therapeutic uses.

3. Standardize labelling to improve readability and safety.

Non-compliance can result in regulatory action, including product recalls or cancellation from the Australian Register of Therapeutic Goods (ARTG).

Acceptable vs. Unacceptable Presentation

• Acceptable:

  • Claims aligned with TGA-approved indications (e.g., “Helps relieve mild stress”).

  • Designs that avoid implying unsupported benefits (e.g., no images of medical professionals).

• Unacceptable:

  • Claims suggesting treatment or prevention of serious diseases (e.g., cancer, diabetes).

  • Use of words like “cure” or “diagnose” unless explicitly approved.

Core Components of the Guidance

1. Listed Medicine Presentation

Sponsors must ensure that the presentation of their listed medicines is not unacceptable. This includes:

• Ensuring the medicine name is not misleading or confusing.

• Avoiding names that suggest the medicine has ingredients or characteristics it does not possess.

• Clearly declaring all therapeutically active ingredients on the label.

• Ensuring the presentation does not lead to unsafe use or suggest purposes not in accordance with approved conditions.

2. Listed Medicine Labels

Key requirements for labels include:

• Displaying the name of the medicine as it appears on the ARTG Certificate of Listing.

• Ensuring the medicine name is presented in an uninterrupted and continuous manner, without disruption by trademarks, graphics, or additional text, as stipulated in subsection 9(2) of TGO 92.

• Sponsors facing challenges in complying with these requirements due to existing branding can request consent for non-compliance under specific conditions.

3. Umbrella Branding

When a sponsor markets different products under a single brand name (e.g., "Bean's Throat Lozenges," "Bean's Multivitamins"), it's crucial to:

• Clearly distinguish between different products to prevent consumer confusion.

• Avoid using a brand name strongly associated with a particular active ingredient or therapeutic use on products with different active ingredients, unless differentiated.

4. Labelling Requirements for Specific Ingredients and Listed Medicines

Sponsors must:

• Ensure that any negative disclosure statements (e.g., "sugar-free") are accurate, even concerning proprietary ingredients.

• Comply with all requirements of the Therapeutic Goods Labelling Order, including the declaration of excipient ingredients on the label, even for ingredients contained within proprietary ingredients.

Label Requirements

1. Mandatory Information: Labels must include:

• Product name and ARTG number.

• Active ingredients and their quantities.

• Directions for use (e.g., dosage, frequency).

• Storage conditions (e.g., “Store below 25°C”).

• Sponsor’s name and Australian address.

2. Critical Health Information Table: Introduced in 2025, this table must be prominently displayed and include:

Section	Details Required
Active Ingredients	Name and quantity per dose.
Indications	Approved uses (e.g., “Relieves mild anxiety”).
Warnings	Contraindications (e.g., “Not for children under 12”).
Directions	Dosage instructions.
Other Info	Allergens, storage, sponsor contact.

3. Allergen Declarations

• Must list allergens like gluten, lactose, shellfish, or nuts if present.

• Exemptions apply during the 4-year transition period for new allergens.

4. Font and Legibility

• Minimum font size: 1.5 mm for critical information.

• High contrast between text and background (e.g., black on white).

Sponsors must diligently review and adhere to these requirements to maintain the integrity of their products in the Australian market.

For detailed information, refer to the official TGA guidance: Understanding Labelling and Presentation Requirements for Listed Medicines