Therapeutic Goods (Authorised Supply of Specified Medicines) Rules March 2018

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Therapeutic Goods (Authorised Supply of Specified Medicines) Rules March 2018

Therapeutic Goods Act 1989

I, LARRY KELLY, a delegate of the Minister for Health for the purposes of subsection 19(7A) of the Therapeutic Goods Act 1989, revoke the Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017 that was registered on 29 September 2017, and make the following Rules.

Dated 12 March 2018

(Signed by)

LARRY KELLY

Delegate of the Minister for Health

1 Name

These Rules are the Therapeutic Goods (Authorised Supply of Specified Medicines) Rules March 2018.

2 Commencement

These Rules commence the day after they are registered.

3 Authority

These Rules are made under subsection 19(7A) of the Therapeutic Goods Act 1989.

4 Authorisation to supply medicines

(1) A health practitioner of the class specified in column 5 in an item in table 1 is authorised to supply a medicine that:

(a) contains only the active ingredient or ingredients, in the strength or concentration (if any), specified in column 1 in the item; and

(b) is in the dosage form specified in column 2 in the item;

to a person if:

(c) the person is a patient of the health practitioner; and

(d) the medicine is to be administered through the route of administration specified in column 3 in the item; and

(e) the supply is for an indication specified in column 4 in the item; and

(f) the following conditions are satisfied:

(i) the health practitioner must inform the patient, or a parent or guardian of the patient, that the medicine is not registered or listed;

(ii) the health practitioner must ensure that the medicine is supplied only after receiving informed consent from the patient, or a parent or guardian of the patient;

(iii) the health practitioner must ensure that the medicine is supplied in accordance with good medical practice;

(iv) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the adverse event, in accordance with subsection (3);

(v) if the health practitioner becomes aware of any defect in the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the defect, in accordance with subsection (3).

(2) A health practitioner is authorised to supply a medicine that:

(a) contains only the active ingredient or ingredients, in the strength or concentration (if any), specified in column 1 in an item in table 1; and

(b) is in the dosage form specified in column 2 in the item;

to a person if:

(c) the person is a patient of another health practitioner (the treating practitioner); and

(d) the treating practitioner is a health practitioner of the class specified in column 5 in the item; and

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

(f) the medicine is to be administered through the route of administration specified in column 3 in the item; and

(g) the supply is for an indication specified in column 4 in the item; and

(h) the following conditions are satisfied:

(i) if the health practitioner supplying the medicine becomes aware that the patient has suffered an adverse event in relation to the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the adverse event, in accordance with subsection (3);

(ii) if the health practitioner supplying the medicine becomes aware of any defect in the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the defect, in accordance with subsection (3).

(3) For the purposes of subparagraphs (1)(f)(iv) and (v) and (2)(h)(i) and (ii), notification must be in accordance with the reporting guidelines set out in the document titled Special Access Scheme Guidance for health practitioners and sponsors, version 1.1, published by the Therapeutic Goods Administration in September 2017.

Table 1: Authorised supply of medicines