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Approved terminology for complementary medicines
ARGCM Part A: General guidance on complementary medicine regulation in Australia
Guidance on Australian approved terminology is provided in the publication TGA approved terminology for medicines, available on the TGA website. The Ingredients Table (located on the TGA Business Services (TBS) website) is a searchable database of approved terminology for chemical, biological and herbal ingredients, including:
- active ingredients
- components of herbal ingredients.
Types of names include:
- Australian Approved Name (chemical) (AAN)
- Approved Biological Name (ABN)
- Approved Herbal Name (AHN) (the Latin binomial of a herbal species).
A complete herbal ingredient name, to be used in ARTG applications and on medicine labels, consists of 3 components: the 'AHN' (identifies the herb species) plus the 'plant part(s) code' plus the 'plant preparation code'.
Instructions on searching the database are provided in ARGCM Part B: TGA Business Services ingredient database.
- Approved Herbal Substance name (AHS): An AHS is used for herbal materials described in a pharmacopoeial monograph. An AHS name is considered a complete name, as the plant part and preparation are described in the monograph.
- Herbal Component Name (HCN): HCNs are names for components that are found in herbal ingredients. A HCN will only be assigned to a component or group of components of a herbal species if it is either a therapeutic marker (where the component has known therapeutic activity) or a quality marker (a chemical marker used for quality control). Generally, a HCN will not be assigned for ubiquitous non-phytochemical components of herbal species, for example: compounds that commonly occur in plant materials. A HCN is not a stand-alone name and should only be used when expressing the herbal component equivalence for a herbal ingredient name.
- Approved Food Name (AFN): AFNs are allocated to substances that are food grade, for example: blackberry. AFNs can only be used as excipient ingredients in therapeutic goods. If the substance is to be included as an active ingredient in a product, the name of the ingredient must be expressed in AHN format, for example: Rubus fruticosus fruit + preparation.
The Code Tables (located on the TGA Business Services (TBS) website) provide terminology (for example: routes of administration, dosage forms) for use in product applications and on medicine labels, where relevant.
Applying for new Australian approved name
When submitting an application for evaluation of a complementary medicine substance (including a new substance in a proposed registered complementary medicine) that does not have an approved name, the applicant should submit a proposal for a new name with that application using the appropriate form - see Application forms for proposing names.
Note: Assignment of a name does not imply any recommendation for the use of the substance or that the ingredient has been approved for use in therapeutic goods.