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Complementary medicine presentation
ARGCM Part A: General guidance on complementary medicine regulation in Australia
Section 3(1) of the Act provides the following definition:
'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
Sponsors should be aware that the overall 'presentation' of a medicine includes such things as (but is not limited to):
- medicine name
- medicine label
- promotional/advertising material
- package inserts
- dosage form
Complementary medicine labels
A product's 'label' includes the label attached to the container (for example: bottle, tube, sachet or blister pack) and the primary pack (for example: carton). Sponsors must ensure the product label and any printed information supplied with the medicine (for example: a package insert) complies with all relevant legislation before it can be supplied in Australia, including advertising requirements. Specific documents relating to medicine labelling requirements include:
- The Therapeutic goods labelling Order as current and in force Part 5-1 (Advertising and generic information) of the Therapeutic Goods Act 1989
- The Therapeutic Goods Advertising Code
- The Therapeutic Goods Regulations 1990
- The Therapeutic Goods (Permissible Ingredients) Determination
- The Medicines Advisory Statements Specification 2016
- The Poisons Standard (the SUSMP) (note: Australian states and territories vary in the way they adopt the Poisons Standard)
- The TGA approved terminology for medicines
Complementary medicines must also comply with any standard and specific conditions applying to registered or listed therapeutic goods under Section 28 of the Act.
Medicine labels for listed medicines are not submitted at the time of listing and are therefore not approved by the TGA. However, listed medicine labels may be reviewed as part of random and targeted compliance reviews - see Compliance reviews of listed complementary medicines.
Medicine labels for registered complementary medicines are evaluated. In evaluating a new registered complementary medicine (and in a listing compliance review of listed complementary 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.
In relation to medicine labels, sponsors should also note the following:
- Graphics, logos and symbols: Non-corporate graphics, logos or symbols on labels should be consistent with the product's approved details, including being appropriate for the claimed therapeutic use of the product. For example: an illustration of a baby would be inappropriate for a product with a dose range starting at 2 years.
- Statements of comparative advertising, professional recommendations, endorsements, sponsorship must all be compliant with the Therapeutic Goods Advertising Code.
- Reference to other products: Reference in labelling to a sponsor's other products may be permitted, provided that the products are included on 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 where no sugars (such as fructose or sucrose) are included.
- Internet addresses: The inclusion of internet addresses on labelling is only acceptable where the information on the website (including any direct links from that website) is consistent with the information included in the ARTG for that product. Websites are considered advertising and are subject to the Therapeutic Goods Advertising Code.
- Label flashes: As a general guideline, label flashes such as 'New Formulation' or 'Now with …' should not be used to describe any product, presentation or therapeutic indication/claim which has been available and promoted in Australia for more than 12 months.
- Excipient ingredients on medicine labels: An excipient ingredient need not be nominated on a medicine label, unless it is a restricted ingredient, for example: included in the Poisons Standard; or included in the First schedule of Therapeutic Goods Labelling order, as current and in force (which lists excipient ingredients required to be mandatorily declared on medicine labels). Where a sponsor chooses to disclose a (non-mandatory) excipient on a medicine label, then all excipients must be disclosed, that is: declaration of excipients on a medicine label cannot be selective.
- 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.