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) current Poisons Standard;

(b) label;

(c) medicine;

(d) supply;

(e) therapeutic use.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

dermal use means application to the skin primarily for localised effect.

divided preparation means a preparation manufactured and packed as discrete pre-measured dosage units prior to supply, and includes tablets, capsules, cachets, single dose powders or single dose sachets of powders or granules.

dosage unit means an individual dose of a medicine for therapeutic use, and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules.

essential oils means:

 (a) products obtained from natural raw materials by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation; or

 (b) oils of equivalent composition to products mentioned in paragraph (a) that are derived through synthetic means; or

 (c) prepared mixtures of oils of equivalent composition to products mentioned in paragraph (a) that comprise a mixture of synthetic and natural components.

external, in relation to the use of a medicine, means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice.

internal use means administration:

 (a) orally, except for topical effect in the mouth; or

 (b) for absorption and the production of a systemic effect:

 (i) by way of a body orifice other than the mouth; or

 (ii) parenterally, other than by application to unbroken skin.

main label means:

 (a) where there are two or more labels or two or more portions of a single label—that label or portion of the label where the product name is more or most conspicuously shown; or

 (b) where the product name is equally conspicuous on two or more labels or portions of a label—each such label or portion.

medicine in a prescribed class means medicine included in a class of medicine prescribed by the Regulations for the purposes of paragraph 3(5)(ca) of the Act.

MRDD or maximum recommended daily dose means the maximum approved dose per day for a medicine used for its main indication in adults.

Regulations means the Therapeutic Goods Regulations 1990.

signal words, in relation to a substance included in a schedule to the current Poisons Standard, means the signal word or words as specified in subsection 5(4).