Australian regulatory guidelines for complementary medicines (ARGCM)
Version 6.0, October 2016
Overview of listed complementary medicines
Listed medicines are considered 'low risk' medicines. Most, but not all, complementary medicines are listed, rather than registered, on the Australian Register of Therapeutic Goods (ARTG) (however, note that not all listed medicines are complementary medicines, for example: sunscreens and 'export only' medicines are also listed medicines).
Regulation 10 of the Therapeutic Goods Regulations 1990 (the Regulations) provides the therapeutic goods that should be either listed or registered on the ARTG. In order for a complementary medicine to be eligible for listing on the ARTG, it needs to be of a kind mentioned in Schedule 4 to the Regulations.
On 1 January 2016 the TGA commenced a new legislative instrument under section 26BB of the Act which contains a list of ingredients permitted for use in listed medicines, the Permissible Ingredients Determination.
Medicines listed on the ARTG are assigned a unique AUST L number, which must be displayed on the medicine label.
Unlike registered medicines, we do not evaluate listed medicines prior to inclusion on the ARTG. The listing process allows for rapid market access for listed complementary medicines. Upon submission of a listing application, a sponsor legally certifies (under section 26A of the Act) that their medicine meets all applicable legislative requirements in relation to safety, quality and efficacy.
As listed medicines are not evaluated, we use a variety of mechanisms to assure the safety and quality of the ingredients used, as well as the resultant listed medicines. One of these mechanisms is that after listing on the ARTG, a proportion of listed medicines are reviewed for compliance with regulatory requirements.
In order for a complementary medicine to be listed on the ARTG it:
- may only contain low risk (active, excipient and homoeopathic preparation ingredients) ingredients permitted for use in listed medicines
- may only carry indications permitted for use in listed medicines
- must not be a prohibited import for the purposes of the Customs Act 1901
- must not be required to be sterile
- must comply with all legislative requirements in relation to quality, safety and efficacy.
Ingredients permitted for use in listed medicines
Listed complementary medicines may only contain low risk ingredients permitted for use in listed medicines as included in the Permissible Ingredients Determination. To be consistent with their low risk status, regulatory limits/requirements may be placed on the use of certain ingredients in listed medicines. These are specified in the Permissible Ingredient Determination.
The majority of ingredients that can be included in listed medicines are those that were included in therapeutic goods supplied in Australia before the Act came into operation in 1991. Since then, all new active and excipient ingredients have undergone a safety assessment by the TGA. If a person wishes to include an active or excipient ingredient that is not currently approved for use in listed medicines, the substance must be evaluated by the TGA before such use is permitted.
Ingredients derived from animal materials may present a safety risk to consumers, as they may contain certain viruses and/or agents capable of carrying Transmissible Spongiform Encephalopathies (TSEs). Information on the TGA's approach to minimising the risks associated with ingredients of human or animal origin is available in Guidance 10: Adventitious agent safety of medicines. Pre-clearance of animal derived ingredients should be sought from TGA before making a medicine application - refer to Pre-clearance application for animal-derived ingredients).
The current regulatory system provides for listed medicines to contain a wide range of herbal substances provided that it can be adequately demonstrated that the herbal substance is safe. Addition guidance on herbal materials and herbal materials and extracts is provided on our website:
- Identification of herbal materials and extracts
- Equivalence of herbal extracts in complementary medicines
- Guidance on the use of modified unprocessed herbal materials in complementary medicines
TGA Business Services ingredient database
A searchable database of ingredients is accessible via the TGA Business Services website. Instructions on searching this database are provided below.
Searching for ingredients via the TGA Business Services website
Select 'Public TGA Information' from the left hand menu.
- From the dropdown menu select 'Ingredients'.
- Enter the ingredient name or synonym you are looking for in the 'search field' and ensure that in 'all fields' is selected. Click 'Go'.
- When looking at the search results, the right hand column will indicate if the ingredient is 'listable' (that is, if the ingredient is able to be included in listed medicines). The ingredient summary must be checked to determine in what context the ingredient is listable (Step 5).
- To the left of each ingredient is a down arrow icon. Click on this icon to reveal the 'Ingredient summary'. The 'Ingredient summary' provides the approved role of the ingredient (active or excipient).
Information on 'Product warnings', amongst other things, can be accessed via 'Code tables' under 'Public TGA Information' on the left hand menu.
This database will only provide the approved name or synonym for the ingredient. Sponsors must be aware of any ingredient restrictions, such as those in the Poisons Standard or in the Permissible Ingredients Determination. It is the sponsor's responsibility to ensure that all ingredient restrictions are met. For example; vitamin B6 above a certain dose is scheduled and therefore no longer listable.
Note that substances marked as components (C) are Herbal Component Names which are not approved as substances in their own right and only can be used in conjunction with an approved source. For example, iodine is not approved as a substance in its own right, but is permitted when expressed as a component of Fucus vesiculosus (kelp), which is known to naturally contain iodine.
Some substances refer to edible substances fit for human consumption as a food and are permitted as excipients only (Approved Food Names), for example: apple, pear. Only certain preparations are permitted for most food excipients, such as: fresh dry or powdered plant material and fresh, dried or concentrated juices. Juice preparations may only be named where the fresh plant part has a high water content.
Indications permitted for use in listed complementary medicines
In relation to therapeutic goods, the definition of 'indications' is provided in section 3 of the Therapeutic Goods Act 1989 (the Act) as: 'the specific therapeutic use/s of the goods'. 'Therapeutic use' is also defined in section 3 of the Act.
Indications must be included in the ARTG entry for a medicine. Statements or claims which do not convey a specific therapeutic use do not need to be included in the ARTG, for example: references to the properties of the product or the packaging, such as '25% more' or 'new formula'.
At the time of listing, applicant/sponsors must certify that they hold evidence to support any indications as well as any other claims made for the medicine - refer to Requirements of section 26A of the Act).
When listing a complementary medicine on the ARTG via the electronic application portal (refer to Listed medicines application and submission user guide), sponsors are able to enter indications for their listed medicine by either selecting from a list of 'standard indications' or by entering their own specific indication using a 'free text' field. The standard indications are provided to sponsors as a convenience. Selecting an indication from the standard indications list does not absolve a sponsor from any obligations under the Act or related regulations.
Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations) states that for a medicine to be eligible for listing, the sponsor of the medicine cannot propose an indication that refers to the treatment of any of the diseases, conditions, ailments or defects specified in Appendix 6 Parts 1 or 2 of the Therapeutic Goods Advertising Code. Medicines with these indications must be registered, rather than listed, on the Australian Register of Therapeutic Goods.
It is a separate requirement that any advertising for complementary medicines (including advertising by way of inclusion of an indication on the label or packaging of a medicine) comply with the advertising requirements set out in Part 5-1 of the Act and the Therapeutic Goods Advertising Code - refer to Advertising requirements for complementary medicines.
Under these advertising requirements it is both an offence under the Act (see paragraph 42DL(1)(c)) and a breach of the Therapeutic Goods Advertising Code (see clause 5(2)) for a sponsor to refer to a 'serious form' of any disease, condition, ailment or defect listed in Part 2 of Appendix 6 of the Therapeutic Goods Advertising Code without prior TGA approval. Such a reference is known as a restricted representation - refer to Prohibited and restricted representations in advertising for complementary medicines. An approval can be given either in response to an application by a sponsor or advertiser under section 42DF of the Act or generally under section 42DK of the Act.
For the removal of any doubt, these regulatory requirements apply notwithstanding that the advertising relates to an indication selected by the sponsor from the list of standard indications.
The TGA is developing a comprehensive list of permitted indications for sponsors to be able select when entering their medicine on the ARTG.
Indications relating to vitamin and mineral supplementation
Vitamin or mineral supplementation indications are only permitted where the recommended daily dose of the product provides at least 25% of the Australian Recommended Dietary Intake (RDI) for that vitamin or mineral. If there is no Australian RDI for a vitamin or mineral, an RDI from another country may be used. Indications should not refer to the presence of vitamins or minerals unless they are present in the recommended daily dose of the product to at least the level of 10% of the RDI, unless there is evidence to support a therapeutic effect below this level. The dose must be consistent with the evidence to support the indication being made.