Listed medicines are considered to be lower risk and are therefore subjected to a lower level of regulation. Listed medicines include vitamins, minerals, traditional and other complementary medicines, and sunscreens. Registered medicines are considered to be higher risk and must meet stricter criteria before being supplied in Australia.
The criteria that needs to be met before a medicine is ‘eligible for listing’ is outlined in Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations). Schedule 4 the the Regulations describes nine broad categories of medicine that can be ‘listed’ on the ARTG instead of being registered. Thee categories most commonly used by the complementary medicines industry are:
- medicines (captured by item 3 of the Schedule)
- homoeopathic preparations (captured by items 4A and 5 of the Schedule)
- sunscreens (captured by item 7 of the Schedule)
- medicine kits (captured by item 12) of the Schedule.
The requirements for these medicines relate to the types of ingredients they contain and the types of claims that they make.
Medicines – Item 3 of Schedule 4
For medicine to be eligible for listing,:
- only contain ingredients that are included in the Permissible Ingredients Determination
- not include any ingredients that are in a Schedule to the Poisons Standard
- not be the type of medicine that must be sterile
- not contain indications for the treatment of a disease listed in Appendix 6 of the Advertising Code.
These requirements apply concurrently. For example, an ingredient may need to meet requirements from the Poisons Standard and even tighter requirements in the Permissible Ingredients Determination.
Learn more: what is the permissible ingredients determination?
If a medicine breaches any of these requirements, it cannot be listed on the ARTG but could be registered instead.
Homoeopathic preparations – Items 4A & 5 of Schedule 4
The eligibility for listing criteria for homoeopathic medicines depend on whether the preparation contains ingredients that are more or less dilute than a 1000x dilution of a mother tincture.
If homoeopathic preparations contain ingredients that are less dilute than 1000x dilution of a mother tincture then they must:
- only contain ingredients from the Permissible Ingredients Determination
- not be the type of medicine that must be sterile
- not include any ingredients that are in a Schedule to the Poisons Standard.
If homoeopathic preparations contain ingredients that are more dilute than 1000x dilution of a mother tincture then they must:
- only contain ingredients from the Permissible Ingredients Determination
- not be the type of medicine that must be sterile
- make indications for the treatment of a disease listed in Appendix 6 of the Advertising Code.
Sunscreens – Item 7 of Schedule 4
Sunscreens can be listed on the ARTG if:
- the sun protection factor (SPF) and performance statements comply with the Sunscreen Standard
- they only contain ingredients from the Permissible Ingredients Determination
- they are not for the treatment of a disease listed in Appendix 6 of the Advertising Code.
Kits – Item 12 of Schedule 4
Medicine kits that are made up of one or more medicines or medicines and biologicals can be listed on the ARTG.
Once included on the ARTG, these products are issued with an AUST L number which must be included on the front of medicine labels.
Follow the links below to learn more about your regulatory requirements:
What is the Therapeutic Goods (Permissible Ingredients) Determination?
What do I need to know about the Advertising Code?