5Definitions

5 Definitions

(1)  In this Specification:

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.

Labelling Order means either Therapeutic Goods Order No.69 – General requirements for labels for medicines, made by the Minister under section 10 of the Act (as amended from time to time and published on the Federal Register of Legislation) or Therapeutic Goods Order No.92 – Standards for labels of non-prescription medicines, made by the Minister under section 10 of the Act (as amended from time to time and published on the Federal Register of Legislation)

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 has the same meaning as in the Act.

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

MRDD (Maximum recommended daily dose) is the maximum approved dose per day for a medicine used for its main indication in adults.

Regulations means the Therapeutic Goods Regulations 1990.