Australian regulatory guidelines for complementary medicines (ARGCM)

Version 5.3 July 2015

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31 July 2015

Types of complementary medicines

Herbal medicines

Herbal medicines are therapeutic goods that are, or contain as the major active ingredient(s), herbal substances. Herbal substances are preparations of plants, and other organisms that are treated as plants in the International Code of Botanical Nomenclature, such as fungi, algae and yeast. For listed medicines, ingredients of herbal origin must meet the definition of a herbal substance included in the Regulations - refer to 'Ingredients permitted for use in listed medicines'.

Traditional medicines

Traditional medicines include a diverse range of health practices, approaches, knowledge and beliefs incorporating medicines of plant, animal and/or mineral origin. Examples of traditional paradigms include: Traditional Chinese medicine, Ayurvedic medicine, Aboriginal and Torres Strait Islander medicine and Western herbal medicine.

Traditional use is defined in Part 1(2) of the Regulations:

traditional use, for a designated active ingredient, means use of the designated active ingredient that:

  1. is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and
  2. accords with well-established procedures of preparation, application and dosage

An established tradition of use is considered to be three generations of human use, equating to approximately 75 years.

Homoeopathic medicines

In Australia, medicines containing homoeopathic preparations are considered to be low-risk medicines and are regulated under the Act.

Part 1(2) of the Regulations provides the following definition:

homoeopathic preparation means a preparation:

  1. formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and
  2. prepared according to the practices of homoeopathic pharmacy using the methods of:
    1. serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
    2. serial trituration in lactose

A 'homoeopathic preparation' is based upon the central tenet of homoeopathy 'let like cure like' and the principles of homoeopathic pharmacy - 'potentisation', being the serial dilution and succussion of a stock. Homoeopathic medicines are derived from a wide variety of natural source materials, mostly plants and minerals. Some of these source materials are poisonous, for example: Atropa belladonna. The highly diluted nature of homoeopathic preparations is considered to render starting materials non-toxic and therefore safe for therapeutic use.

The term 'mother tincture' means a preparation prepared by the process of solution, extraction or trituration. Homoeopathic medicines are manufactured to different medicinal strengths or ‘potencies’ according to manufacturing standards described in homoeopathic pharmacopoeias. The expressions of homoeopathic potencies are provided below:

  • 'nX' (or 'D') potency: where each dilution of the mother tincture is a decimal or 10-fold dilution and 'n' is the number of dilutions, such that the total dilution is 10n. For example: a 1X potency represents a 1:10 dilution; 2X a 1:100 dilution; 3X a 1: 1,000 dilution; 4X a 1:10,000 dilution.
  • 'nC' potFency: where each dilution of the mother tincture is a centesimal or 100-fold dilution and 'n' is the number of dilutions, such that the total dilution is 100n. For example: a 1C potency represents a 1:100 dilution; 2C a 1:10,000 dilution.
  • 'M' potency: refers to a homoeopathic preparation that has undergone 1,000 potentisation steps in the centesimal scale. For example: 1M potency represents a 1,000C dilution; 2M a 2,000C dilution.
  • 'nLM' (or 'Q'): where each dilution from a mother tincture first potentised to a 3C starting material is a quinquagintamillesimal or 50,000-fold dilution and 'n' is the number of dilutions, such that the total dilution is 50,000n. For example: a LM/01 (or Q/01) potency represents a 1:50,000 dilution from a 3C starting potency; LM/02 (or Q/02) a 1:50,000 dilution from a LM/01 (or Q/01) potency, and so on.

Homoeopathic preparations exempt from inclusion on the ARTG

Where a medicine meets the definition of ‘homoeopathic preparation’ and meets the conditions set out under Item 8 of Schedule 5 to the Regulations it is exempt from the requirement to be included on the ARTG. Note that this does not apply where the homoeopathic preparation is part of a medicine containing other ingredients requiring inclusion on the ARTG.

Schedule 5

  1. the following medicines unless the indications proposed by the sponsor are in the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Therapeutic Goods Advertising Code:
    1. homoeopathic preparations more dilute than a one thousand fold dilution of a mother tincture and which are not required to be sterile; and which do not include an ingredient of:
      1. human origin; or
      2. animal origin, if the ingredient consists of, or is derived from, any of the following parts of cattle, sheep, goats or mule deer:
        1. adrenal;
        2. brain;
        3. cerebrospinal fluid;
        4. dura mater;
        5. eye;
        6. ileum;
        7. lymph nodes;
        8. pineal gland;
        9. pituitary;
        10. placenta;
        11. proximal colon;
        12. spinal cord;
        13. spleen;
        14. tonsil

That is, most homoeopathic preparations that are more dilute than a 1,000 fold dilution of a mother tincture (4X and above) are not required to be on the ARTG as they are considered to be sufficiently low risk. Some homoeopathic medicines however, are required to be on the ARTG - refer to Homoeopathic preparations required to be listed on the ARTG.

A homoeopathic medicine prepared by practitioners specifically for an individual patient, after consultation with that patient, does not need to be entered on the ARTG - refer to Exemptions for extemporaneously compounded and dispensed complementary medicines.

Homoeopathic preparations required to be listed on the ARTG

Items 4 and 4A of Part 1 of Schedule 4 to the Regulations state that the following therapeutic goods are required to be included in the part of the ARTG for listed goods:

  1. mother tinctures
  2. 4A. homoeopathic preparations that:
    1. consist of, or contain a dilution of, mother tincture that:
      1. is a 1,000 fold dilution, or a lesser dilution, of that mother tincture; and
      2. is not required to be sterile; and
      3. is not included in a Schedule to the Poisons Standard or Appendix C of the Poisons Standard otherwise than because of a component that is more than a 1,000 fold dilution of a mother tincture; and
    2. do not consist of, or contain as a component, a preparation of a herb specified in Part 4 of this Schedule as a 1,000 fold dilution, or a lesser dilution, of a mother tincture.
  1. homoeopathic preparations (where each dilution is more dilute than a one thousand fold dilution of a mother tincture), each of which:
    1. is not required to be sterile; and
    2. according to the indications proposed by the sponsor of the preparation, is for the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Therapeutic Goods Advertising Code

That is, mother tinctures and 1X, 2X and 3X homoeopathic preparations must be included on the ARTG to be supplied in Australia.

Homoeopathic medicines that contain a substance that is in:

  • a Schedule or Appendix C to the Poisons Standard; or
  • Part 4 of Schedule 4 to the Regulations

may be able to be listed on the ARTG, provided that the ingredient is more dilute than a 1,000 fold dilution of the mother tincture (that is, 4X or above) and the medicine is not required to be sterile.

Manufacturing requirements for homoeopathic preparations

In Australia, homoeopathic medicines that:

  • are not required to be sterile
  • only contain homoeopathic preparations that are more dilute than a 1,000 fold dilution of the mother tincture (4X or above)

are exempt from the Australian requirement that the manufacturer must hold a GMP license - refer to Item 7 of Schedule 7 to the Regulations.

Specific labelling requirements for homoeopathic preparations

All commercially supplied homoeopathic medicines in Australia, regardless of whether they are included on the ARTG, must:

  • comply with advertising requirements set out in Schedule 2 of the Regulations
  • be labelled in compliance with the general requirements for labels for medicinal products as current and in force (currently TGO 69), and any other applicable official standards.

TGO 69 Part 3 includes some special requirements for homoeopathic preparations:

3(15) Homoeopathic preparations
Where all the active ingredients in the goods are homoeopathic preparations then:

  1. the label on the container and the label on the outside of the primary pack if any, must include, in addition to the relevant requirements in subclauses 3(2) and 3(3), a statement indicating that the active ingredients in the goods are homoeopathic preparations, such as, 'homoeopathic product' or 'homoeopathic preparation'; and
  2. where the indications for use are of a kind permitted to be advertised only to persons described in subregulations 4(1) and 4(2) of the Regulations, the label on the container and the label on the outside of the primary pack if any, must include a statement that the therapeutic indications have not been approved, such as 'Homoeopathic product without approved therapeutic indications'.

3(16) Formulations containing both homoeopathic and non-homoeopathic ingredients
Where goods contain active ingredients that are homoeopathic preparations and other active ingredients that are not homoeopathic preparations -

  1. the label on the container and the label on the outside of the primary pack, if any, must include, in addition to the relevant requirements in subclauses 3(2) and 3(3), a statement that the goods include ingredients that are homoeopathic preparations, such as 'Contains homoeopathic ingredients'; and
  2. (b) where the indications for use are of a kind permitted to be advertised only to persons described in subregulations 4(1) and 4(2) of the Regulations, the label on the container and the label on the outside of the primary pack, if any, must include a statement that the therapeutic indications of the homoeopathic ingredients have not been approved, such as, 'Contains homoeopathic ingredients without approved therapeutic indications'.

Guidance on indications for homoeopathic medicines

The Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines detail the requirements for making therapeutic indications for listed medicines, including homoeopathic medicines listed on the ARTG.

A homoeopathic product can carry claims specified in Part 1 or 2 of Appendix 6 of the Therapeutic Goods Advertising Code and be listed on the ARTG. This is provided the medicine is not displayed or advertised to the general public for purposes outside those permitted by the Therapeutic Goods Advertising Code and the Regulations, for example: it is supplied solely to practitioners. However, in accordance with TGO 69, the label on the container and on the primary pack must include a statement to indicate that the medicine contains homoeopathic ingredients with indications that have not been ‘approved’ by the TGA.

Anthroposophic medicines

Anthroposophic practitioners use a range of interventions including conventional therapies, remedies based upon homoeopathic principles, herbal medicine and external therapies.

Essential oils

The purpose of a product containing an essential oil determines which agency regulates it. That is, if the product makes only cosmetic claims it is considered a cosmetic and regulated by National Industrial Chemicals Notification and Assessment Scheme (NICNAS), but if the product makes a therapeutic claim it would be considered a therapeutic good and regulated by the TGA.

Sponsors of products containing essential oil(s), which are considered to be therapeutic goods must comply with all statutory requirements, including: the default standards, The Poisons Standard; TGO No. 69 - General requirements for labels for medicines; and TGO No. 80 - Child Resistant Packaging Requirements for Medicines.

Essential oils that are supplied solely as starting materials to practitioners are generally exempt from the requirement to be included on the ARTG before supply - refer to Exempt goods.

Vitamins and minerals

As with all complementary medicines, there are various legislative requirements which must be addressed in relation to medicines containing vitamins and minerals in order for them to be included on the ARTG. For example, the Therapeutic Goods Advertising Code states that an advertisement for vitamins must not imply that vitamin supplements are a substitute for good nutrition or a balanced diet. Other relevant legislative documents include: TGO 69, TGO 78 and Required Advisory Statements for Medicine Labels (RASML).

Many vitamins and minerals are scheduled in The Poisons Standard and in accordance with this scheduling, such things as pack size and container dimensions may be limited.

Nutritional substances

Some nutritional substances are regulated as foods and others are regulated as therapeutic goods. Refer to Food/complementary medicine interface. Examples of nutritional substances, if presented as therapeutic goods, that are considered to be complementary medicines include fish oils, shark cartilage and krill oil.

Essences (flower, shell, gem/crystal)

Essences (for example: flower, shell, gem/crystal) are not generally regulated as medicines in Australia, unless they have therapeutic indications. In general, indications in relation to spiritual or emotional states (apart from those that state or imply depression or other mental illness) are not considered therapeutic indications.

Unless exempt goods, any product for which therapeutic indications are made by the sponsor must be entered on the ARTG before it can be legally imported, exported, manufactured or supplied for use in Australia.

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