4Definitions

4 Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

1.       health practitioner;
2.       health professional;

(b) indications;

(c) label;

(d) medicine;

(e) presentation;

(f) Register;

(g) Therapeutic Goods Advertising Code.

  In this instrument:

Act means the Therapeutic Goods Act 1989

Code Tables are tables that can be accessed from the Therapeutic Goods Administration Business Service website at www.ebs.tga.gov.au under the heading “Public TGA Information”, as at the commencement of this instrument.

Dentist means a person who is registered under the Health Practitioner Regulation National Law in the dentistry profession.

Doctor means a medical practitioner.

Evidence guidelines means the TGA document titled Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines, published on the TGA’s website (www.tga.gov.au), as at the commencement of this instrument.

Medically diagnosed, in relation to a disease, condition, ailment or defect, is where the disease, condition, ailment or defect has been diagnosed by a suitably qualified medical practitioner.

Medical practitioner means a person who is registered under the Health Practitioner Regulation National Law in the medical profession.

Regulations mean the Therapeutic Goods Regulations 1990.

Scientific means a scientific indication.

Scientific indication means an indication that is supported by scientific evidence, such as clinical studies or systematic reviews, as described in the Evidence guidelines.

Serious, in relation to a form of a disease, condition, ailment or defect, has the same meaning as in the Therapeutic Goods Advertising Code.

TGA means the Therapeutic Goods Administration.

Traditional means a traditional indication.

Traditional Ayurvedic medicine means a traditional Ayurvedic medicine indication.

Traditional Ayurvedic medicine (TAY) indication means a traditional indication that is based on traditional use in the Ayurvedic medicine paradigm.

Traditional Chinese medicine means a traditional Chinese medicine indication.

Traditional Chinese medicine (TCM) indication means a traditional indication that is based on traditional use in the traditional Chinese medicine paradigm.