Types of ingredients in listed and registered complementary medicines

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ARGCM Part A: General guidance on complementary medicine regulation in Australia

5 February 2018

Active ingredients in complementary medicines

The definition of an active ingredient is included in Regulation 2 of the Regulations:

'active ingredient', for a medicine, means a therapeutically active component in the medicine's final formulation that is responsible for its physiological or pharmacological action.

Excipient ingredients in complementary medicines

An excipient ingredient is not therapeutically active and does not contribute to the physiological or pharmacological action within the medicine's final formulation. Types of excipient ingredients include: a fragrance, flavour, preservative, printing ink, antioxidant, coating, binding agent, filler or an anticaking agent.

Sponsors of complementary medicines should ensure that the role of an excipient ingredient is appropriate and in an appropriate quantity for this purpose within the product formulation. Indications cannot be made for excipient ingredients.

Colourings permitted for use in complementary medicines

Colours used in oral products must be approved for such use - refer to 'Colourings used in medicines for topical and oral use'.

Incidental minor excipients in complementary medicines

Incidental minor excipients (IME) are substances that are added to certain raw material ingredients during the manufacture of that ingredient, for the purpose of increasing its stability, extending shelf-life or improving physical properties. IME are themselves substances that are approved for use in listed medicines and are present in the raw material at levels such that their concentration in the finished medicine is insignificant.

Note: an ingredient that is subject to any restriction or is required to be declared cannot be considered as an incidental minor excipient.

The TGA currently recognise specific instances where an IME included in the raw material may vary, for example:

  • minor changes required to the type of anti-oxidant used in the manufacture of different batches of some oil raw material ingredients, such as fish oil
  • the possible presence of silicon dioxide when used as an anti-caking agent in some ingredients.

In the above cases, the anti-oxidant or silicon dioxide ingredients are considered to be IME and applicants are not required to disclose details of these substances (used in the manufacture of an ingredient) in the listing application (for a medicine whose formulation includes that ingredient).

We will give consideration to recognising other IMEs, if suitable justification is provided. Please contact complementary.medicines@health.gov.au for such enquiries.

Proprietary ingredients in complementary medicines

Proprietary ingredients are entered into the TGA Business System (TBS) by the TGA, using details submitted by the supplier of the ingredient or by a medicine sponsor (on behalf of the supplier) using the Notification of a new proprietary ingredient form. This allows for the capture of complex formulation details and other relevant information, and the provision of a unique name and number. Sponsors may select proprietary ingredients using the assigned ingredient ID number for use in their application for a listed or registered medicine.

Proprietary ingredients may be excipient formulations or active pre-mixes. Proprietary ingredients consisting of excipient formulations include fragrances, flavours, colouring ingredients, trans-dermal patch adhesives and printing inks.

Active pre-mix proprietary ingredients can contain only one active ingredient to be included in listed medicines via the TGA Business Services system.

For any proprietary ingredient to be eligible for inclusion in a listed complementary medicine, all ingredients included in the proprietary ingredient’s formulation must be permitted for use in listed medicines. Information about the eligibility of ingredients for use in listed medicines can be found in the Therapeutic Goods (Permissible Ingredients) Determination. The colourings contained in proprietary ingredients used in listed medicines are required to be only colourings used in medicines for topical and oral use.

The following limits apply to the concentration allowed in listed medicines for proprietary ingredients that are flavours, fragrances and inks:

  • Flavours 5%
  • Fragrances 1%
  • Inks 0.1%

If an ingredient in the proprietary ingredient formulation is not permitted for use in listed medicines the ingredient must be evaluated, either as a new substance for use in listed medicines (see ARGCM Part C) or its safety must be established as part of the evaluation process for a registered medicine.

The specifications applied to proprietary ingredients should be appropriate for the nature of the ingredient, and for its function and proportion in the finished product. For an active pre-mix, specifications must include tests for the identification and content of the active ingredient and impurity tests.

For further information on proprietary ingredients, refer to the Notification of a new proprietary ingredient page on the TGA website.

Proprietary ingredient commercially confidential information

Certain information supplied in relation to the inclusion of proprietary ingredients in TBS is treated as commercially confidential information. Commercially confidential information provided to us will be treated as follows:

Labelling associated with proprietary ingredients in complementary medicines

If the label of a medicine that includes a proprietary ingredient includes a negative disclosure statement (for example: 'sugar free'), sponsors must ensure that the substance referred to in the negative disclosure statement is not contained in any proprietary ingredient in the product formulation. The onus is on the sponsor to obtain this assurance from the supplier.

Sponsors must also ensure that their medicine label complies with all the requirements of the Therapeutic Goods labelling Order as current and in force, including the declaration of excipient ingredients that must be declared on the medicine label.

Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) commenced on 31 August 2016 and has a 4 year transition period. During this time, complementary (non-prescription) medicines must comply with either TGO 92 or Therapeutic Goods Order No. 69. General requirements for labels for medicines (TGO 69). Sponsors must specify which order they are compliant with. On and from 1 September 2020, these medicines must comply with TGO 92.

Good manufacturing requirements for proprietary ingredients

Australian manufacturers who are involved in the manufacture of active ingredients, mixtures containing active ingredients and any other step taken to bring therapeutic goods to their final state (for example: intermediate manufacturing steps, testing, packaging/labelling and release for supply) are required to have a licence under Part 3-3 of the Act, unless specifically exempted.

Where a proprietary ingredient comprises multiple active ingredients or 'excipient plus active' ingredient formulations, manufacture of the proprietary ingredient may be considered a significant step in the manufacture of the finished product and evidence of licensing or approval of the manufacturer may be required.

However, where a proprietary ingredient is used in an excipient role within the medicine (for example: colours, printing inks, flavours, fragrances, and preservatives) evidence of Good Manufacturing Practice (GMP) is not required.

Active Herbal Extracts

An 'Active Herbal Extract' is a herbal extract or concentrate for which a supplier intends specific information on the extraction method, steps and/or solvent details, to remain confidential from sponsors who include the extract as an active ingredient in a medicine. The formulation can contain only one active herbal ingredient, but may also contain excipient ingredient(s). To be a permitted ingredient in listed medicines, the active ingredient must comply with the definition of a herbal substance (as defined in Regulation 2 of the Regulations).

For more information refer to the Guide to the completion of the 'Notification of selective non-disclosure of Active Herbal Extract details' form and the Notification of selective non-disclosure of Active Herbal Extract details form.

In relation to Good Manufacturing Practice requirements for Active Herbal Extracts see Good manufacturing practice requirements for proprietary ingredients.

Amino acid chelates

The TGA defines a metal amino acid chelate as a complex consisting of a metal ion with one or more proteinogenic amino acid ligands bound to it in such a way that the metal ion is part of a ring within the molecule.

Currently a number of metal amino acid chelates are included in the Permissible Ingredients Determination and are therefore eligible for inclusion in medicines listed on the ARTG. We have determined a number of specific names for these ingredients to enable sponsors to identify ingredients accurately - refer to new ingredient names for metal amino acid chelates.

Ingredients in listed complementary medicines

Listed medicines may only contain low risk (active and excipient) ingredients that are permitted for use in listed medicines - refer to Ingredients permitted for use in listed complementary medicines. When listing a medicine the sponsor must certify that all ingredients in their medicine are eligible for listing.

Australian native and endangered species in complementary medicines

In Australia, the export and import of wildlife, wildlife specimens and products made or derived from wildlife is regulated under the Environment Protection and Biodiversity Conservation Act 1999 (the EPBC Act). This includes the movement of endangered species listed under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and of Australian native species.

For queries regarding the importation of restricted/endangered species and the general importation of plant material, please refer to the following authorities:

The TGA does not have the legislative power to reject listing or registration applications on the grounds that they contain a substance derived from a species that is subject to State or Australian Government environmental regulation. This may result in the situation where therapeutic goods that are listed or registered on the ARTG may be seized at Customs if they are exported or imported.

It is the responsibility of sponsors of therapeutic goods containing substances that are derived from Australian native or endangered species to be aware that controls on the trade of these goods may exist and comply with those requirements.

Genetically modified substances in complementary medicines

The nationally consistent legislative scheme for regulating gene technology comprises the Commonwealth Gene Technology Act 2000, the Gene Technology Regulations 2001 and corresponding State and Territory legislation - refer to the Office of the Gene Technology Regulator website. It is the responsibility of sponsors including genetically modified substances in their complementary medicine to ensure they comply with the provisions of all relevant legislation.

For applications for new complementary medicine substances and new registered complementary medicines, the applicant must advise us if the proposed substance is, or is obtained from, a genetically modified organism. We will assess the safety, quality and, where relevant, efficacy of the genetically modified organism or material in the same way as for any other new complementary medicine substance or new registered medicine.