Complementary medicines exempt/excluded from certain regulatory requirements
ARGCM Part A: General guidance on complementary medicine regulation in Australia
Where there is some doubt as to whether a product may fall within the definition of a therapeutic good it may be declared not to be a therapeutic good under section 7 of the Act, where the Secretary has a reasonable basis for arriving at that decision. Refer to Declarations made under section 7 of the Act for more information. A consolidated list of excluded goods is provided in Therapeutic Goods (Excluded Goods) Order No. 1 of 2011.
Some medicines do not need to be registered or listed on the ARTG as a result of a specific exemption or determination under the Act (refer to section 18 of the Act and Schedules 5 and 5A of the Regulations). These include, for example:
- Medicines (other than those used for gene therapy) that are dispensed or extemporaneously compounded by a practitioner for use by a particular person - refer to Complementary medicine practitioner medicines/exemptions.
- Certain homoeopathic preparations - refer to Homoeopathic medicines.
- Certain shampoos for the treatment/prevention of dandruff.
- Starting materials used in the manufacture of therapeutic goods, except when pre-packaged for supply for other therapeutic purposes or formulated as a dosage form.
These goods are exempt from Part 3-2 of the Act, relating to inclusion on the ARTG, however it is important to note that all other applicable requirements under the Act and the Regulations must be complied with.
Some medicines or persons are exempt from the manufacturing requirements set out in Part 3-3 of the Act. The criteria for manufacturing exemptions are provided in Section 34 of the Act, together with Schedule 7 (exempt medicines) and Schedule 8 (exempt persons) of the Regulations.
Schedule 7 of the Regulations provides the following as exempt from the operation of Parts 3-3 of the Act:
- ingredients, except water, used in the manufacture of therapeutic goods where the ingredients:
- do not have a therapeutic action; or
- are herbs, bulk hamamelis water or oils extracted from herbs, the sole therapeutic use of which is as starting materials for use by licensed manufacturers
For example: the Australian manufacturer of a 'bulk' essential oil (the farmer extracting oil from lavender plants) does not need to be licensed for Good Manufacturing Practice (GMP). However, the Australian manufacturers who undertake steps in the manufacturing of the finished dosage form (such as filling, blending, testing, labelling and release for supply) are required to hold the appropriate GMP licence.