Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022

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

Dated     15 December 2022

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  Authorisation

Schedule 1—Biologicals authorised for supply

Schedule 2—Repeals

Therapeutic Goods (Biologicals—Authorised Supply) Rules 2020

1  Name

  This instrument is the Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022.

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Note: This table relates only to the provisions of this instrument as originally made.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 subsection 32CM(7A) 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) biological;

(b) health practitioner;

(c) included in the Register;

(d) Register;

(e) sponsor;

(f) supply.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

SAS Guidance means the document titled Special Access Scheme Guidance for health practitioners and sponsors (Version 1.1, September 2017) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.

Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.

5  Authorisation

Supply by a specified health practitioner

 (1) A health practitioner specified in column 5 of an item in the table in Schedule 1 is authorised to supply a biological to a patient of that practitioner where:

 (a) the biological is specified in column 2 of that item; and

 (b) the biological is to be administered by the route specified in column 3 of that item; and

 (c) the supply is for the indication specified in column 4 of that item; and

 (d) the conditions specified in subsection (2) are satisfied.

 (2) The health practitioner must:

 (a) inform the patient, or a parent or guardian of the patient, that the biological is not included in the Register; and

 (b) obtain informed consent from the patient, or a parent or guardian of the patient, in relation to, and before, the supply of the biological; and

 (c) supply the biological in accordance with good medical practice or the relevant code of conduct for the health practitioner; and

 (d) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the biological—notify the Therapeutic Goods Administration and the sponsor of the biological about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

 (e) if the health practitioner becomes aware of a defect in the biological—notify the Therapeutic Goods Administration and the sponsor of the biological in accordance with the reporting guidelines set out in the SAS Guidance.

Supply to a patient of a specified health practitioner

 (3) A health practitioner is authorised to supply a biological to a patient of a health practitioner specified in column 5 of an item in the table in Schedule 1 (the treating practitioner) where:

 (a) the biological is specified in column 2 of that item; and

 (b) the supply is requested by the treating practitioner; and

 (c) the biological is to be administered by the route specified in column 3 of that item; and

 (d) the supply is for the indication specified in column 4 of that item; and

 (e) the conditions specified in subsection (4) are satisfied.

 (4) The health practitioner supplying the biological must:

 (a) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the biological—notify the Therapeutic Goods Administration and the sponsor of the biological about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

 (b) if the health practitioner becomes aware of a defect in the biological—notify the Therapeutic Goods Administration and the sponsor of the biological in accordance with the reporting guidelines set out in the SAS Guidance.

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

Schedule 1—Biologicals authorised for supply

Note: See section 5.

Schedule 2—Repeals

Note: See section 6.

Therapeutic Goods (Biologicals—Authorised Supply) Rules 2020

1  The whole of the instrument

Repeal the instrument