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Approved names for ingredients

TGA approved terminology for therapeutic goods

11 November 2019

Approved names are used in the regulation of therapeutic goods to:

  • ensure only one name is used to specify a substance (to avoid confusion)
  • ensure that the name clearly and unambiguously identifies the substance for identification and testing purposes
  • ensure consistency of names with international conventions, e.g. International Non-proprietary Names (INNs)

Names are included in the Ingredients Table to ensure the correct name is included in online medicine applications and any associated documentation.

Please note:

  • The inclusion of a name in the Ingredients Table does not imply any recommendation or approval for the use of that substance in therapeutic goods.
  • There are two stages to making an ingredient available for use in a product:
    • approval of the appropriate name

    and

    • evaluation of the ingredient/product for use.
  • Some ingredients in the Ingredients Table may not currently be included in goods on the ARTG.

Ingredient and tissue name categories

There are various categories of ingredients, in accordance with their source. The approved ingredient and tissue name categories (and types of products they can be used in) are in Table 1 below.

Table 1: Ingredient categories
Name category Substance type Description
Australian Approved Name (AAN) Chemical Approved names for chemical substances. (includes antibiotics)
Approved Biological Name (ABN) Biological

Approved names for biological substances derived from human, animal or microbiological sources for use in medicines.

The ABN includes the name of the organism, and may include the part of the organism and the preparation.

ABNs do not include plants, fungi, yeasts or antibiotics.

Approved Cell and Tissue Name (ACN) Cell and tissue For ingredients used in products that are regulated under the regulatory framework for biologicals, e.g. human and living animal cells and tissues. ACNs are not given to ingredients used in medicines.
Approved Herbal Name (AHN) Herbal

The genus and species name (in the Latin binomial format) of a herb.

The genus, species, plant part and preparation (including solvents and extract ratio, if applicable) are included to name a herbal ingredient correctly.

Approved Herbal Substance Name (AHS) Herbal

For herbal ingredients that are fully characterised in a monograph of an accepted pharmacopoeia (usually the British Pharmacopoeia, European Pharmacopoeia or United States Pharmacopeia) e.g. Orange Oil in the British Pharmacopoeia.

The identity and quality of the substance must comply with the monograph that is the source of the substance name. This is an exception to the way that naming references usually apply (see section 3.3 Ingredient naming references).

Approved Ingredient Name (AIN) Herbal

Used in association with complex herbal ingredients that:

  • have been assessed by TGA

and

  • do not meet the Therapeutic Goods Regulations 1990 definition of a herbal substance.

Applicants cannot apply for an AIN. AINs are determined as part of the TGAs evaluation of the substance.

Herbal Component Name (HCN) Herbal

These are used for a particular constituent or a class of constituents in herbal ingredients, and are most often needed where a class of constituents is restricted, e.g. hydroxyanthracene derivatives.

An HCN is not a stand-alone name. It is used in conjunction with the name of the herbal ingredient of which it is a constituent (the 'parent' ingredient).

Approved Food Name (AFN) Food grade

Allocated to food grade substances, e.g. orange.

  • In addition to the AFN, the name of the 'preparation' of the food ingredient (e.g. orange juice) is required to form the approved name for the substance.
  • AFNs are only for use as excipient ingredient names in therapeutic goods.
  • If the substance is to be included as an active ingredient in a product, the name of the substance is to be expressed in AHN format, e.g. Citrus sinensis fruit juice.

The AFN category has been superseded and no new AFNs will be created.

You should use the Approved Herbal Name (AHN) or the Approved Herbal Substance (AHS) name to identify botanical materials used as active ingredients in medicines.

Proprietary ingredients

Proprietary Ingredients (PIs) are fixed formulations comprising a mix of individual ingredients. Examples include flavours and fragrances. They are not given approved names and are not considered an ingredient category of their own. The ingredients within the proprietary formulation must be identified using Australian approved names.

These formulations are included in the Proprietary Ingredients Table, which is a separate list. PIs are given a unique number that can be used to identify the ingredient mix in online applications to the TGA.

For more information, see the Notification of a new proprietary ingredient page on the TGA website.

Requirements for approved names

Ingredients that require an approved name

An approved name is required for all ingredients in a therapeutic good. Ingredients can be single molecular entities or complex natural mixtures (e.g. herbal extracts).

Substances that do not require an approved name

Substances that are not required to be identified in the formulation of goods on the ARTG do not require an approved name. Examples include:

  • chemical and biological starting materials
  • some types of growth media
  • manufacturing solvents that are removed in the manufacturing process.

Herbal components do not need approved herbal component names (HCNs) unless it is mandatory that they be declared in the ARTG entry. Sponsors may make claims about herbal components on their label without an approved HCN, as long as the claims are true and comply with regulatory requirements.

Trademarked ingredient names

If a substance has been registered under a trademark in Australia, the trademarked name cannot be used as an approved ingredient name.

If a trademarked name was adopted as an Australian approved name, other sponsors would be required to include that name on their labels. This could result in a breach of trademark legislation.

Punctuation and 'inversion' of names

Punctuation

Punctuation marks are not generally used in ingredient names as they reduce searchability within the Ingredients Table. Where appropriate, punctuation is used as descriptors and designators in the names of chemicals, e.g. 1,3-butylene glycol and cis-3-hexen-1-ol.

Inversion of names

Historically, some ingredient names were expressed in an inverted form to assist with indexing. For example, 'insulin - bovine' rather than 'bovine insulin'. In this example, the correct approved name that must be on a label is 'bovine insulin'.

Specific rules for spelling of chemical names

Alfa vs alpha

Use of 'alpha' or 'alfa' in an ingredient name depends on the context:

  • 'alfa' is used for active ingredients in biological medicines, to differentiate between similar ingredients
  • 'alpha' is used to name a structural isomer.

Sulfur & sulphur

Sulfur (rather than sulphur) is used in names containing this word or its derivatives, e.g. sulfate, sulfonate.

Alternative 's' or 'z' spellings

Ensure words that have alternative 's' or 'z' spellings, e.g. hydrolysed / hydrolyzed, are spelt with an 's', consistent with Australian spelling conventions.

International Non-proprietary Name (INN) spelling conventions

These conventions are applied to ingredient naming, where consistent with the international approach, and include:

  • using 'i' instead of 'y' - e.g. sibutramine mesilate instead of sibutramine mesylate
  • using 't' instead of 'th' - e.g. butizide instead of buthiazide
  • using 'e' instead of 'ae' or 'oe' - e.g. estrogen instead of oestrogen
  • using 'f' instead of 'ph' - e.g. sulphacetamide is now listed as sulfacetamide
  • avoiding the use of 'h' and 'k' - e.g. colecalciferol instead of cholecalciferol.

Synonyms

Synonyms for ingredients are only included in the Ingredients Table for cross-referencing, to assist with identification and searchability.

Synonyms must not be used in place of the approved names:

  • on labels of medicines or other therapeutic goods sold in Australia
  • in applications for entry of goods on the ARTG
  • anywhere else the approved name is required.
Medicines containing herbal ingredients

A synonym or common name can be included in addition to the approved botanical name on medicine labels, as long as the label complies with requirements in the medicine labelling Orders. See section 7.5 Additional information on medicine labels.

Ingredient naming references

Naming references are used to determine the most appropriate name for an ingredient. The naming reference is the publication that was the source of the proposed name, e.g. a monograph.

Naming references usually include the definition or description of the substance. These reference definitions provide a guide so the substance's characteristics can be analysed to verify that it is correctly identified.

In most cases, the name stated in the title of the monograph (or other reference) will be adopted as the Australian approved name for the ingredient.

Naming reference versus quality standard

All therapeutic goods must comply with relevant standards. These can be ministerial standards (such as the Therapeutic Goods Orders) or default standards (for example, monographs in the British Pharmacopoeia or the United States Pharmacopeia-National Formulary).

Using a particular reference to define a name does not always mean that it is also the standard that defines the quality of the substance. For example, Merck is used as a naming reference but is not a standard under the Act.

In some instances, the naming reference is a standard, but it may not be the only relevant default standard. For example, the naming reference for 'nicotinamide' may be the British Pharmacopoeia, however a default standard that may be used to define the quality of the ingredient could be the monograph in the United States Pharmacopeia - National Formulary which refers to the same ingredient as 'niacinamide.' In these circumstances, the alternative ingredient name may be included as a synonym to assist with searchability in the Ingredients Table.

Please note

An exception to the way naming references usually apply is made for Australian Herbal Substance (AHS) names where the identity and quality of the substance must comply with the monograph that is the naming reference for the substance name.

Where there are different names for an ingredient

There may be situations where an ingredient appears under different names in several of our primary naming references. In this situation, the alternative names not accepted may be included in the Ingredients Table as a synonym of the approved name.

Modified reference codes in the Ingredients Table

The word 'modified' following a reference in the Ingredients Table indicates that the name has been adapted from the title or entry in the naming reference, rather than being identical. This is because the name in the reference is spelled slightly differently from the approved name, e.g. dimethylol dimethyl hydantoin as the AAN instead of DMDM hydantoin. To indicate the difference between the names, the reference is International Cosmetic Ingredient Dictionary (modified) and the suffix 'M' is included in the reference code as follows: ICIDM. The definition in the ICID still defines the ingredient.

Modified references are also used where a name with an INN and its salt are approved at the same time but an appropriate reference for the salt does not yet exist.

Default references for AANs and ABNs

International Non-proprietary name (INN) terminology, maintained by the World Health Organization (WHO), is the default naming reference for chemical ingredients (AANs) and biological ingredients derived from human or animal materials (most ABNs).

If you want to use a different name

If an ingredient has an INN and you want to use a different name:

  • you will need to justify the use of a different name
  • we will review the suitability of alternative names on a case-by-case basis.

Further guidance on INN naming

Additional references for AANs and ABNs

If no INN is available, we prefer the following alternative references:

  • British Pharmacopoeia (BP)
  • European Pharmacopoeia (EP)
  • United States Pharmacopeia - National Formulary (USP)
  • British Approved Names (BAN)
  • United States Adopted Name (USAN)
  • Other internationally recognised references include Martindale, Food Chemicals Codex, International Cosmetic Ingredient Dictionary, Chemical Abstracts Service and the Merck Index. The full list of references are available on ingredient proposal forms and the Code Tables.

If no monograph is available

If the ingredient does not have an entry in any of the references above, we will consider other references, preferably well-recognised, peer-reviewed journals.

Further information on preferred references is available on the proposal forms for ingredient names.

Herbal naming references for AHNs

Herbal ingredients are named using Latin binomial nomenclature, including genus and species. For example, the Latin binomial for sage is Salvia officinalis.

Subspecies are included where this better defines the ingredient and where the different species are therapeutically relevant such as Brassica oleracea var. botrytis for cauliflower or Brassica oleracea var. italica for broccoli.

We use a number of naming references to name herbal species for Approved Herbal Names (AHNs). The Kew Science Medicinal Plant Name Services is the preferred reference for Approved Herbal Names. This is because it is regularly updated and actively maintained. See preferred herbal naming references in Table 2.

Table 2: Preferred herbal naming references
Herbal Naming Reference Acronym
Plant Name Services MPNS
The Plant List TPL
Germplasm Resource GRIN
Tropicos TRP

Fungi and algae are treated as plants in the International Code of Botanical Nomenclature. We include these in the Approved Herbal Name category but we use different references. See Table 3 for these preferred references.

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Table 3: Other naming references (by kingdom)
Other Kingdom References Naming Reference Acronym
Algae Algaebase ALGA
FungiIndex Fungorum IF

TGA reference code

Some Australian approved names use the reference code 'TGA <year>'. This indicates that there no INN and/or a suitable entry in any of our accepted references.

To view the full list of reference codes, refer to the Code Tables homepage on the TGA Business Services website (TBS).