4Definitions

4  Definitions

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

(a) health practitioner;

(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 means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services, as in force or existing from time to time.

dentist means a person registered as a dentist under a law of a State or Territory that provides for the registration of dentists.

doctor means a medical practitioner.

evidence guidelines means the document titled Supporting claims and indications for listed medicines, published by the Therapeutic Goods Administration, as in force or existing from time to time.

Note: The evidence guidelines are published at www.tga.gov.au.

health professional means a person mentioned in paragraph 42AA(a), (aa), (c) or (d) of the Act.

medically diagnosed, in relation to a disease, ailment, defect or injury, means a disease, ailment, defect or injury that is diagnosed by a suitably qualified medical practitioner.

medical practitioner means a person registered as a medical practitioner under a law of a State or Territory that provides for the registration of medical practitioners.

Regulations means the Therapeutic Goods Regulations 1990.

scientific, in relation to the type of evidence for an indication, means evidence that is based on scientific research and quantifiable data, as described in the evidence guidelines.

Note: Scientific evidence includes relevant clinical trials on humans and systematic reviews.

serious, in relation to a form of a disease, ailment, defect or injury, has the same meaning as in section 28 of the Therapeutic Goods Advertising Code, in relation to a form of a disease, condition, ailment or defect.

TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration’s website which may be accessed on the internet at www.ebs.tga.gov.au.

Therapeutic Goods Administration, or TGA, has the same meaning as in the Regulations.

traditional, in relation to the type of evidence for an indication, means evidence of traditional use in a recognised paradigm outside modern conventional medicine, as described in the evidence guidelines.