Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Warfarin) Instrument 2023

I, Nicholas Henderson, as delegate of the Minister for Health and Aged Care, make the following instrument.

Dated 16 March 2023

Nicholas Henderson

Acting First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of Health and Aged Care

Contents

1  Name

2  Commencement

3  Authority

4  Definitions

5  Declaration of a serious scarcity

6  Substitution of scarce medicine by pharmacists

7  Period instrument in force

8  Repeals

Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances

Schedule 2—General permitted circumstances

1  Name

  This instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Warfarin) Instrument 2023.

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.

Note: This table relates only to the provisions of this instrument as originally made.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 section 30EK 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) medicine;

(b) Register;

(c) registered goods;

(d) registration number.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

pharmacist has the same meaning as in subsection 30EK(6) of the Act.

prescriber means the person who:

 (a) is authorised under a law of a State or Territory to prescribe medicine; and

 (b) prescribed the scarce medicine for the patient.

registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.

scarce medicine has the meaning given by section 5.

substitutable medicine has the meaning given by section 6.

tablet has the same meaning as in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.

Note: TGO 101 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.

5  Declaration of a serious scarcity

  For paragraph 30EK(1)(a) of the Act, a serious scarcity of the medicine specified in column 2 of each item in the table in Schedule 1 (the scarce medicine) across the whole of Australia is declared.

6  Substitution of scarce medicine by pharmacists

  For paragraph 30EK(1)(b) of the Act, in relation to each item mentioned in the table in Schedule 1, each medicine specified in column 3 (the substitutable medicine) is permitted to be dispensed by a pharmacist in substitution for the scarce medicine specified in column 2, in the circumstances specified in:

 (a) column 5 of that item (the specific permitted circumstances); and

 (b) the table in Schedule 2 (the general permitted circumstances).

Note: Substitution is only permitted where both the specific permitted circumstances and the general permitted circumstances exist.

7  Period instrument in force

  This instrument remains in force until 7 August 2023.

8  Repeals

  Unless repealed earlier, this instrument is repealed at the start of 8 August 2023.

Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances

Note: See sections 5 and 6.

Schedule 2—General permitted circumstances

Note: See section 6.