Requirements for Listing Complimentary Medicines on the ARTG

Complementary Medicines (including vitamin, minerals, herbal medicines and homeopathic preparations) in Australia are regulated by the Therapeutic Good Administration (TGA) and must adhere to certain regulatory requirements. This is to ensure the safety and efficacy of the product.

Most complementary medicines are Listed Medicines (AUST L); however, they may also be regulated as Registered or Assessed Listed Medicines. The latter two options require a higher level of evidence on the efficacy of the ingredients/product.  

In accordance with the TGA Evidence Guidelines, there are 4 key considerations to having your products Listed on the (ARTG):

Ingredients

All ingredients used in Listed Medicines must be listed in the Permissible Ingredients Determination which means they are considered low-risk ingredients and are pre-approved for use in Listed Medicines. In addition, these ingredients must not be included in the schedules of the Poison Standard. If an ingredient is not in the Permissible Ingredients Determination, then it cannot be used in the medicine. 

Evidence

If the ingredients are permitted for use in Listed Medicines, evidence must be provided demonstrating their efficacy.  This evidence can be in the form of scientific literature (utilising scientific textbooks, studies and clinical trials) or traditional evidence which typically utilises traditional monographs from pharmacopoeias and materia medicas.  This evidence is compiled in a document called the Evidence Package which must be held on file by the sponsor.

Claims

There are strict guidelines around the claims that can be made on a Listed Medicine product. The claims are based on the evidence of the ingredients and selected from a list of Therapeutic Goods Permissible Indications Determination which describes the therapeutic use of the product. Since Listed Medicines are considered ‘low-risk medicines’, Permitted Indications have been assessed against a set of criteria and determined to be appropriate for listed medicines. These criteria are intended to ensure that permitted indications will only cover (and listed medicines will be limited to making) indications relating to:

  • health maintenance
  • health enhancement
  • prevention of a non-serious vitamin or mineral dietary deficiency; or
  • certain non-serious, self-limiting diseases, ailments, defects or injuries.

GMP Compliance

In Australia, the manufacturers of therapeutic goods (including listed and complementary medicines) must hold a TGA GMP licence or overseas equivalent for all steps of manufacture and for the dosage form/type.  Where a product is imported, each nominated international manufacturer must demonstrate an acceptable standard of good manufacturing practice (GMP) as would be required of an Australian manufacturer. Pre-clearance of international manufacturers is mandatory for listed complementary medicines.  This pre-clearance (or GMP clearance) is required before an application is made. Sponsors are required to maintain evidence of GMP Compliance of an overseas manufacturer as a standard condition of registration or listing of a therapeutic good.

In addition to the above points, a product also needs to be evaluated in terms of the dosages it provides, product name, labelling and advertising as these are all subject to TGA guidelines.

We Can Help Get Your Product to Market.

Got a new product idea or existing product ready to go?

Our experienced team at DTS can guide you every step of the way and offer services to assist with: product development and formulation, existing product compliance reviews, compilation of evidence packages, reviews of label and marketing copies, completing TGA application submissions and advising on all your regulatory and compliance needs.

References:

TGA. (2019). Evidence Guidelines. Sourced from: https://www.tga.gov.au/publication/evidence-guidelines

TGA. (2019). Manufacturing Basics. Sourced from: https://www.tga.gov.au/manufacturing-basics