Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (Cth)

Therapeutic Goods (Medicines Advisory Statements) Specification 2021

I, Jane Cook, as delegate of the Minister for Health and Aged Care, make the following specification.

Dated 22 December 2021

Dr Jane Cook First Assistant Secretary Medicines Regulation Division Health Products Regulation Group Department of Health

Contents 1 Name 2 Commencement 3 Authority 4 Definitions 5 Interpretation 6 Application 7 Medicines advisory statements 8 Transitional arrangements 9 Repeals Schedule 1—Required Advisory Statements for Medicine Labels No. 6

1 Name This instrument is the Therapeutic Goods (Medicines Advisory Statements) Specification 2021.

2 Commencement (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument 1 January 2022. 1 January 2022

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument. (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority This instrument is made under subsection 3(5A) of the Therapeutic Goods Act 1989.

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). topical use means application of a substance for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.