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; and

(d) 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 sale or 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 products obtained from natural raw materials either by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation.  It also means:

 (a) oils of equivalent composition derived through synthetic means; or

 (b) compounded oils of equivalent composition comprising 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.

Poisons Standard means the current Poisons Standard as in force on the commencement of this instrument.

Regulations means the Therapeutic Goods Regulations 1990.

signal heading means the signal word or words relating to a Schedule to the SUSMP in which the substance is included and the purpose for which it is to be used, as shown in the following table: