Complementary medicines: what they are
ARGCM Part A: General guidance on complementary medicine regulation in Australia
In Australia, medicinal products containing such ingredients as certain herbs, vitamins and minerals, nutritional supplements, homoeopathic medicines and aromatherapy products are referred to as 'complementary medicines' and are regulated as medicines by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989 (the Act) and the supporting Therapeutic Goods Regulations 1990 (the Regulations) - refer to Regulation basics.
Part 1(2) of the Regulations provides the following definitions:
Complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.
Designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14 (to the Regulations).
Schedule 14 to the Regulations provides a list of designated active ingredients:
Designated active ingredients
- an amino acid
- a choline salt
- an essential oil
- plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll
- a homoeopathic preparation
- a microorganism, whole or extracted, except a vaccine
- a mineral including a mineral salt and a naturally occurring mineral
- a mucopolysaccharide
- non-human animal material (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates
- a lipid, including an essential fatty acid or phospholipid
- a substance produced by or obtained from bees, including royal jelly, bee pollen and propolis
- a sugar, polysaccharide or carbohydrate
- a vitamin or provitamin