Understanding labelling and presentation requirements for listed medicines

Applicants of all listed medicines are required to certify against the Therapeutic Goods Act 1989 (the Act) that the presentation of the medicine is not unacceptable. Listed medicines are certified against section 26A(2)(c) of the Act and assessed listed medicines are certified against section 26AB(2)(c) of the Act.

Section 3(1) of the Act defines presentation:

‘Presentation' in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.

Some aspects of the medicine that are considered to comprise the ‘presentation’ include (but are not limited to):

• the Australian Register of Therapeutic Goods (ARTG) entry of the medicine
• the medicine name
• the medicine label, including symbols and pictures, logos, indications, directions for use, warning and cautionary statements, claims, etc.
• packaging
• dosage form
• advertising material, including advertising on websites, blogs or social media platforms, consumer reviews and testimonials, etc.

The TGA routinely monitors the presentation of medicines listed in the ARTG, including their advertising.

Breaches related to the advertising of a medicine can generally be taken to also constitute unacceptable presentation.

If any aspect of a medicine’s presentation is found to be unacceptable, it can be cancelled from the ARTG (under section 30 of the Act) and the sponsor might face civil and/or criminal penalties for committing offences under various sections of the Act.

Unacceptable presentation of a listed medicine

Section 3(5) of the Act and 3(A) of the Therapeutic Goods Regulations 1990 (the Regulations) state when the presentation of a good is considered unacceptable.

Section 3(5) of the Act states:

(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and, without limiting the previous words in this subsection, the presentation of therapeutic goods is unacceptable:

(a) if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or

(b) if a name applied to the goods is the same as the name applied to other therapeutic goods that are supplied in Australia where those other goods contain additional or different therapeutically active ingredients; or

(c) if the label of the goods does not declare the presence of a therapeutically active ingredient; or

(ca) if the therapeutic goods are medicine included in a class of a medicine prescribed by the regulations for the purposes of this paragraph—if the medicine’s label does not contain the advisory statements specified under subsection (5A) in relation to the medicine; or

(d) if a form of presentation of the goods may lead to unsafe use of the goods or suggests a purpose that is not in accordance with conditions applicable to the supply of the goods in Australia; or

(e) in prescribed cases.

Section 3(A) of the Regulations states:

(1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in  those goods being mistaken for or confused with confectionary or toys is an unacceptable presentation of the goods.

(2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.

Examples of unacceptable presentations include, but are not limited to:

Labelling and composition issues

• Therapeutically active ingredients present in the formulation not being declared on the medicine label (and/or misleadingly declaring them as ‘excipients’ in the ARTG application).
• A medicine name that is misleading as to the composition of the medicine.
• For a reformulated product, not including appropriate information on the label where the new medicine has different active ingredients, allergens and/or warnings from the product previously supplied under that name.
• A medicine with an identical name to a therapeutic good already included in the ARTG but with different active ingredient(s) and/or formulation.

Misleading claims and advertising

• Making statements attributing a therapeutic role to ingredients declared as non-therapeutically active (excipients) in the ARTG entry.
• Making statements (including through the medicine name) or including pictures suggesting that the product has therapeutic uses (indications) or actions different from, or in addition to, the indications included in the ARTG.
• Including claims that a formulation is ‘hypo-allergenic’ or ‘non-irritant’ when the sponsor does not hold supportive evidence from clinical tests that can be produced on request by us.
• Including claims that a product is free from certain substances, for example: ‘free from artificial colours’, when it is not true.
• Advertising medicines to population groups that are not consistent with the intended uses of the goods or contradict legislative requirements, such as the required warning statements or indication requirements. For example, a medicine only has indications for children over 2 years of age but includes ‘baby’ or ‘infant’ in the product name.

Dosage and usage information

• Not stating the appropriate dosage for all age-groups in the likely target population of the medicine. For example, a medicine directed to adults and children that does not include the specific dosages for ‘children 6-12 years’, ‘children 13-18 years’, ‘adults’, etc.
• Having inappropriate dosage forms or directions for use for the target population of the medicine. For example: a capsule dosage form is not appropriate for infants.
• Omitting warning or cautionary statements needed for proper and safe use of the medicine.

Presentation and packaging concerns

• Presenting a medicine in a form likely to result in it being confused with food, for example: in confectionery-like novelty shapes and packaging.

Advertising of listed medicines

Breaches related to the advertising of a medicine can generally be taken to also constitute unacceptable presentation.

For information about the advertising of medicines, go to:

• Applying the Advertising Code
• Restricted and prohibited representations.

A label is defined in the Act as:

label, in relation to therapeutic goods, means a display of printed information:

(a) on or attached to the goods; or

(b) on or attached to a container or primary pack in which the goods are supplied; or

(c) supplied with such a container or pack.

Sponsors must ensure the product label and any printed information that you choose to supply with the medicine (for example: a package insert) complies with all relevant legislation before it can be supplied in Australia, including advertising requirements.

Listed medicine labels must comply with any labelling requirements applicable under or provided in, but not limited to:

• the Therapeutic goods labelling order as current and in force
• Part 5-1 (Advertising and generic information) of the Therapeutic Goods Act 1989
• Therapeutic Goods Advertising Code
• Therapeutic Goods Regulations 1990
• Therapeutic Goods (Permissible Ingredients) Determination
• Therapeutic Goods (Permissible Indications) Determination
• the Poisons Standard (the SUSMP) (note: Australian States and Territories vary in the way they adopt the Poisons Standard)
• TGA approved terminology for therapeutic goods
• Australian/New Zealand Sunscreen Standard

In relation to medicine labels, listed medicine sponsors should note:

Labelling consistency

• Non-corporate graphics, logos or symbols on labels should be consistent with the product's ARTG entry, including being appropriate for the claimed therapeutic uses of the product. For example: an illustration of a pregnant woman would be inappropriate for a product that has indications that are not permitted for pregnancy.
• Reference to other products: reference in labelling to a sponsor’s other products may be permitted, provided that the products are included in the ARTG (or exempt).
• Negative disclosure statements such as ‘gluten free’ or ‘sugar free’ must be true of all ingredients in the medicine, including proprietary ingredients. The statement ‘sugar free’ is acceptable if no sugars (such as fructose or sucrose) are included.
• Excipient ingredients are not required to be nominated on a medicine label, unless required by legislation, for example: if it is included in Schedule 1 of Therapeutic Goods Order  No. 92 – Standard for labels of non-prescription medicines (TGO 92); or if section 10(2) of TGO 92, as current and in force (which lists substances required to be mandatorily declared on medicine labels).
• If you choose to declare an excipient on a medicine label that is not required by legislation, you need to make sure that the presentation of the excipient information does not constitute an unacceptable presentation. An example of unacceptable presentation is when excipient ingredients are selectively presented to imply that it contributes to the therapeutic activity of the medicine. On the other hand, declaration of excipient information, such as ‘chocolate flavour’, may be considered acceptable presentation as it allows the consumer to make an informed choice about the product.

Advertising and claims

• Statements of comparative advertising, professional recommendations, endorsements and sponsorship must all be compliant with the Therapeutic Goods Advertising Code.
• Information on websites of listed medicines should be consistent with the medicine label and ARTG entry. Websites are advertising and are subject to the Therapeutic Goods Advertising Code.
• Advertising should not imply therapeutic uses that do not align with the medicine’s ARTG entry and the listed medicines framework. For example, websites focused on pregnancy should avoid linking to other listed medicines with indications not permitted for use during pregnancy. Similarly, websites focused on infertility should not include pages for listed medicines with indications for the reproductive system, which are not permitted to refer to infertility.
• While non-therapeutic claims are not required to be included in the medicine’s ARTG entry and can be used in advertising, if a claim is considered to imply a therapeutic use, then a permitted indication of similar intent must be included in the medicine’s ARTG entry.
• Label flashes such as ‘New Formulation’ or ‘Now with …’ must be truthful, accurate and not misleading.
• Therapeutic sunscreens may carry non-therapeutic claims provided they are truthful and not misleading (e.g. cosmetic claims, such as ‘moisturising’). However, a sponsor must be able to substantiate all claims made, see Australian Regulatory Guidelines for Sunscreens.

International and non-English information

• Products that are supplied in Australia and also exported to another country may include international product registration numbers (in addition to the ARTG number) required by the importing country.
• When presenting non-English information, the information should be consistent with the ARTG entry and Australian legislative requirements.

TGA assessment of medicine labels

Medicine labels for listed medicines are not pre-market assessed by the TGA. However, listed medicine labels may be post-market assessed by us as part of compliance monitoring, investigations or reviews. See Understanding listed medicines compliance reviews.

Medicine labels for assessed listed medicines and registered complementary medicines are assessed by us pre-market. In assessing these medicines, all aspects of the medicine presentation, including proposed labelling and package inserts, are assessed for compliance with the various legislative requirements (including advertising requirements). This is to ensure clarity is provided for consumers in relation to the medicine and its proposed use.

Listed medicine name on labels

Medicine labels are required to display the name of the medicine as it appears on the ARTG Certificate of Listing. Inclusion of a brand name, as part of the ‘name of the product’ in the ARTG will result in this being considered ‘the name of the medicine’ for the purposes of TGO 92. Similarly, it would be clear that the name, inclusive of the brand name component, would be used to identify the goods for recall purposes. Generally, the TGA would anticipate that a brand name would be included in the ARTG because it is intended to uniquely identify the medicine and is an effective means to uniquely identify the goods for recall purposes.

Umbrella branding

‘Umbrella’ or ‘family’ branding describes the situation where a sponsor markets different products under the one brand name (e.g. Bean’s Throat Lozenges, Bean’s Multivitamins, Bean’s Cough Medicine).

Where a well-known brand name is used for products with different active ingredients or different indications, the product name should clearly distinguish the different products from one another.

If a brand name is strongly associated with a particular active ingredient, or therapeutic uses or use in certain population groups, the use of this brand name on a new product range with different active ingredients could cause a consumer to confuse the two product ranges. In these circumstances, the presentation of the product may be considered unacceptable.

Consent for non-compliance with subsection 9(2) of TGO 92

The Therapeutic Goods Order No. 92 (TGO 92) includes requirements to ensure easy readability and identification of key health information, such as active ingredients. These requirements aim to address key concerns from consumers, health practitioners and Poison Centres of the need for easy identification of medicines and the active ingredients in those medicines.

To achieve this, subsection 9(2) of TGO 92 requires that:

• the medicine name be presented in an uninterrupted and continuous manner (i.e. the complete name all in one place on the label).
• the use of trademarks, graphics or additional text must not disrupt the medicine name. This will ensure that the medicine name is clearly recognisable.

Some non-prescription medicine sponsors have raised concerns due to having difficulty complying with the TGO 92 requirements for the presentation of the medicine name because their medicine label includes a long-standing brand name or branding either within or adjacent to the name of the medicine that uniquely identifies a range of products from that sponsor. In some cases, inclusion of a ‘distinguishing mark’ such as a registered trademark, a graphic image, icon or logo, a brand name, slogan or tagline, within or adjacent to the medicine name may cause the medicine’s label to be non-compliant with subsection 9(2) of TGO 92.

To address this, the TGA has established a process for sponsors of non-prescription medicines (which includes: listed, listed assessed, registered complementary and OTC medicines) to request consent for non-compliance with subsection 9(2) of TGO 92 relating to the presentation of the name of the medicine on product labels. Products must meet a set of requirements to be eligible for consideration under this measure. For more information, please see:

• Requesting to supply a non-prescription medicine that is not compliant with the labelling order
• Section 14/14A application form relating to subsection 9(2) of TGO 92

Consideration of potential amendments to the requirements relating to the presentation of the name of the medicine on product labels may occur prior to the sunsetting of the TGO 92.

Labelling requirements for specific ingredients/listed medicines

^[1] In many places in the TGO 92 allows label statements to be followed with “or words to that effect”. In the case of 8(1)(n)(i)(B), TGO 92 does not give that option. As such, only those precise words meet the requirements of TGO 92.

Acronyms and glossary terms