Therapeutic Goods (Medicines Advisory Statements) Specification 2019

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 March 2019. 1 March 2019

Note: This table relates only to the provisions of this instrument as originally made.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; 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:

SUSMP means the Standard for the Uniform Scheduling of Medicines and Poisons, as set out in Schedule 1 to the Poisons Standard.

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.

5  Interpretation

 (1) Unless the contrary intention appears, a reference to a substance in this instrument includes:

 (a) that substance as prepared from natural sources or artificially; and

 (b) where the substance is a plant (other than a plant referred to in Schedules 8 or 9 of the SUSMP), that plant or any part of that plant when packed or prepared for therapeutic use; and

 (c) every salt, active principle or derivative of the substance, including esters and ethers and every salt of such an active principle or derivative; and

 (d) every alkaloid of the substance and every salt of such an alkaloid; and

 (e) except where the stereoisomer is defined in the substance name (e.g. dextromethorphan), every stereoisomer of the substance and every salt of such a stereoisomer; and

 (f) a preparation or admixture containing any proportion of the substance

  but does not include:

 (g) a preparation or product included in Appendix A of the SUSMP; or

 (h) a substance included in Appendix G of the SUSMP at a concentration not exceeding the concentration specified in column 2 of that Appendix in respect of the substance; or

 (i) any other substance included in Schedules 1 to 6 to the SUSMP, at a concentration not exceeding 10 mg per litre or 10 mg per kilogram, unless that substance is also included in Schedule 7 or 8 to the SUSMP.

 (2) Unless the contrary intention appears, where a concentration, strength or quantity is specified in this instrument in respect of a substance:

 (a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance that is listed in this instrument; and

 (b) the expression “one per cent” means:

 (i) in the case of a liquid preparation, 1 gram of the substance per 100 mL of the preparation; or

 (ii) in the case of a solid or semi-solid preparation, 1 gram of the substance per 100 grams of the preparation and

 (iii) any expression of greater or lesser percentages shall have a corresponding meaning; and

 (c) in the case of codeine, such concentration, strength or quantity is calculated as anhydrous codeine.

(3) In Schedule 1, the following symbols in column 3 have the following meanings:

6  Application

  This instrument applies to a medicine that is a medicine in a prescribed class.

7  Medicines advisory statements

 (1) Subject to this section and section 8, the advisory statements mentioned in column 3 of the table in Schedule 1 to this instrument, are specified for the purposes of paragraph 3(5)(ca) of the Act in respect of a medicine in a prescribed class that contains the substance described in column 1 of the corresponding row and in the conditions set out in column 2.

 (2) In addition, the advisory statements mentioned in Schedule 1, where varied or, if more than one such statement applies, combined to form a simple sentence on the label of a medicine in a prescribed class in a manner that does not change the intent of the advisory statement, are specified for the purposes of paragraph 3(5)(ca) of the Act.

Note:  Unless otherwise specified in column 2 of the table in Schedule 1, the requirements only apply if the substance is included in the medicine as an active ingredient.

8  Transitional arrangements

 (1) In this section:

  former specification means the instrument specified in Schedule 2, as in force immediately before the commencement of this instrument.

  transition period, for a medicine in a prescribed class, means the period beginning on the commencement of this instrument, and ending on 31 August 2020.

 (2) Despite the repeal of the former specification in section 9 of this instrument, that specification continues to apply for the duration of the transition period in relation to the classes of medicines prescribed for the purposes of paragraph 3(5)(ca) of the Act, such that the advisory statements specified in the former specification may continue to be used on a label of a medicine, as an alternative to the advisory statements specified under section 7 of this instrument.

Note:  During the transition period, the label of a medicine may contain the applicable advisory statements specified in Schedule 2 of the former specification instead of Schedule 1 to this instrument. However, once the transition period ceases, the label must contain the applicable advisory statements specified in Schedule 1.

9  Repeals

  Each instrument that is specified in Schedule 2 to this instrument is repealed as set out in the applicable items in that Schedule.

Schedule 1—Required Advisory Statements for Medicine Labels No. 5

Note: See section 7.

Table: Required Advisory Statements for Medicine Labels No. 5

Schedule 2—Repeals

Medicines Advisory Statements Specification 2017

1  The whole of the instrument

Repeal the instrument.