Medicines and Poisons (Medicines) Amendment Regulation 2022

1Short title

This regulation may be cited as the Medicines and Poisons (Medicines) Amendment Regulation 2022.

2Commencement

This regulation commences on 1 July 2022.

3Regulation amended

This regulation amends the Medicines and Poisons (Medicines) Regulation 2021.

4Amendment of s 84 (Sending prescription electronically)

(1)Section 84(2), ‘for a diversion-risk medicine’—
omit.

(2)Section 84(3), from ‘Before’ to ‘steps’—
omit, insert—

If the medicine is a diversion-risk medicine, the prescriber must take all reasonable steps, before sending the digital copy,

5Amendment of s 87 (Additional content of written prescription for S8 medicine)

Section 87(2)(a), ‘both’—
omit, insert—

if the prescription is a paper prescription—both

6Amendment of s 159 (Amounts when selling S4 medicine)

Section 159(a), ‘the minimum standard pack’—
omit, insert—

the smallest available size of a manufacturer’s pack of the medicine

7Amendment of s 195 (Definitions for part)

Section 195, definition shared clinic, ‘to more than 1 person’—
omit.

8Amendment of sch 1 (Extended practice authorities and departmental standards)

Schedule 1, part 1, entry for Aboriginal and Torres Strait Islander health practitioners, ‘1’—
omit, insert—

2

9Amendment of sch 2 (Categories of medicines)

Schedule 2, part 1—
omit, insert—

Part 1 Restricted medicines

Division 1 Medicines for human use

The following medicines for human use—

acitretin

ambrisentan

bexarotene

bosentan

buprenorphine for treating opioid dependency

clomifene

clozapine

corifollitropin alfa

cyclofenil or another substance prepared to stimulate ovulation

dinoprost

dinoprostone

enzalutamide

etretinate

follitropin alpha

follitropin beta

hydroxychloroquine

isotretinoin for oral use

ivermectin other than a preparation in oral tablet form for treating a condition shown as an approved indication on the Australian Register of Therapeutic Goods for treatment with ivermectin in oral tablet form

luteinising hormone

macitentan

methadone for treating opioid dependency

riociguat

sodium oxybate

teriparatide

thalidomide

tretinoin for oral use

urofollitropin (human follicle stimulating hormone)

Division 2 Other medicines

amfetamines

lenalidomide

methylphenidate

pomalidomide

10Amendment of sch 6 (Medical practitioners and assistants)

(1)Schedule 6, sections 22, 32 and 58, ‘human’—
omit.

(2)Schedule 6, section 22, items 1 to 4, before ‘thalidomide’—
insert—

restricted ivermectin,

(3)Schedule 6, part 2—
insert—

Division 5A Gastroenterologists and hepatologists

26AClass of person

A medical practitioner who is a specialist registrant in gastroenterology and hepatology.

26BDealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	restricted ivermectin
2	give a treatment dose	restricted ivermectin
3	dispense	restricted ivermectin
4	administer	restricted ivermectin
5	give a purchase order	stock of restricted ivermectin	the stock is not for a specified place
6	possess	restricted ivermectin

(4)Schedule 6, section 36, items 1 to 6, after ‘hydroxychloroquine’—
insert—

, restricted ivermectin

(5)Schedule 6, section 47, items 1 to 6, after ‘hydroxychloroquine’—
insert—

, restricted ivermectin

(6)Schedule 6, section 52—
omit, insert—

52Dealing authorised

1	prescribe	ambrisentan, bosentan, macitentan, riociguat or sodium oxybate
2	give a treatment dose	ambrisentan, bosentan, macitentan, riociguat or sodium oxybate
3	dispense	ambrisentan, bosentan, macitentan, riociguat or sodium oxybate
4	administer	ambrisentan, bosentan, macitentan, riociguat or sodium oxybate
5	give a purchase order	stock of a medicine mentioned in this column	the stock is not for a specified place
6	possess	a medicine mentioned in this column

11Amendment of sch 8 (Ocular treatment professions)

(1)Schedule 8, section 1, definition optometry guidelines, ‘10 September 2018’—
omit, insert—

10 December 2021

(2)Schedule 8, section 3, item 1, column 2, ‘appendix B’—
omit, insert—

appendix A

12Amendment of sch 22 (Dictionary)

(1)Schedule 22—
insert—

Australian Register of Therapeutic Goods means the Australian Register of Therapeutic Goods maintained under the Therapeutic Goods Act 1989 (Cwlth).

restricted ivermectin means a restricted medicine that is ivermectin.

(2)Schedule 22, definition adrenaline (epinephrine) autoinjector, paragraph (b), from ‘maintained’ to ‘(Cwlth)’—
omit.

(3)Schedule 22, definition registered medicine, from ‘maintained’ to ‘(Cwlth)’—
omit.