Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 2) (ACT)
Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 2)
Subordinate Law SL2021-28
The Australian Capital Territory Executive makes the following regulation under the Medicines, Poisons and Therapeutic Goods Act 2008.
Dated 27 October 2021.
Andrew Barr
Chief Minister
Rachel Stephen-Smith
Minister
Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 2)
Subordinate Law SL2021-28
made under the
Medicines, Poisons and Therapeutic Goods Act 2008
Contents
Page
1 Name of regulation 1
2 Commencement 1
3 Legislation amended 1
4 Section 31 (2) and note 1
5 Section 41 (4), definition of relevant approval particulars 2
6 Section 121 (3), definition of authorised prescriber and examples 2
7 Section 124 (1) 2
8 Section 124 (3) 3
9 Section 124 (4), new definition of national residential medication chart 3
10 Section 430 (4), definition of authorised activity, new paragraph (d) 3
11 Sections 555 and 556 3
12 Section 561 (1) (c) (i), except note 5
13 Section 635 (1) 5
14 Section 635 (1), note 2 5
15 Sections 637 and 644 5
16 Section 695 (3), definition of authorised activity, new paragraph (d) 5
17 Section 863 (d) 6
18 New section 863 (g) to (k) 6
19 Section 863, new note 6
20 Schedule 1, part 1.11, item 1, column 3, paragraph (a) (ii) 7
21 Schedule 3, section 3.1, new definition of approved indication 7
22 Schedule 3, part 3.2, item 5, column 2 7
23 Schedule 3, part 3.2, item 6, column 2 7
24 Schedule 3, part 3.2, new items 7 to 9 8
25 Schedule 3, part 3.2, new note 8
26 Dictionary, definition of national residential medication chart prescription 9
Name of regulation
This regulation is the Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 2).
Commencement
This regulation commences on the day after its notification day.
NoteThe naming and commencement provisions automatically commence on the notification day (see Legislation Act, s 75 (1)).
Legislation amended
This regulation amends the Medicines, Poisons and Therapeutic Goods Regulation 2008.
Section 31 (2) and note
substitute
(2)In this section:
national residential medication chart means a medication chart within the meaning of the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth), section 41 (4), as in force from time to time.
NoteThe National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).
Section 41 (4), definition of relevant approval particulars
omit
Section 121 (3), definition of authorised prescriber and examples
substitute
authorised prescriber means—
(a)for a prescription prescribing buprenorphine or methadone for treatment of opioid dependency—a prescriber approved under division 13.1.3 to prescribe the medicine for the treatment of opioid dependency; or
(b)for any other prescription—a prescriber.
Example—paragraph (a)
A doctor employed by an alcohol and drug service prescribing buprenorphine or methadone to treat the opioid dependency for a patient.
Example—paragraph (b)
A doctor practising as a general practitioner prescribing buprenorphine or methadone to treat chronic pain for a patient.
Section 124 (1)
substitute
(1)This section does not apply to—
(a)a prescription written in the medical records of an in-patient at a hospital; or
(b)an electronic prescription, within the meaning of the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth), section 5.
Section 124 (3)
after
dispensed electronic prescription
insert
(other than an electronic prescription mentioned in subsection (1) (b))
Section 124 (4), new definition of national residential medication chart
insert
national residential medication chart—see section 31 (2).
Section 430 (4), definition of authorised activity, new paragraph (d)
insert
(d)if the relevant medicine is integral to genuine medical or scientific research at the institution—reasonable use of the medicine to carry out the research.
Sections 555 and 556
substitute
Standing approval to prescribe controlled medicines for hospital in-patient or patient discharge
A designated prescriber is approved to prescribe a controlled medicine for a patient of the prescriber if—
(a)the patient is an in-patient at a hospital; or
(b)the prescription is issued—
(i)as part of the patient’s discharge from a hospital; and
(ii)for the patient’s use of the controlled medicine for a period of not more than 7 days.
NoteA hospice is a hospital (see Macquarie Dictionary, 8th ed, def hospice).
Standing approval to prescribe controlled medicines for short-term treatment
(1)A designated prescriber is approved to prescribe a controlled medicine for a patient of the prescriber during a short‑term treatment period if—
(a)the prescriber believes on reasonable grounds that the patient—
(i)is not a drug-dependant person in relation to a controlled medicine or prohibited substance; and
(ii)has not been prescribed the same controlled medicine by another prescriber in the 2-month period immediately before the day the prescriber prescribes the controlled medicine; and
(b)the prescriber has not prescribed the same controlled medicine to the patient in the 2-month period immediately before the short-term treatment period; and
(c)the prescriber prescribes the controlled medicine for the patient’s use during the short-term treatment period only.
NoteFor prescribing controlled medicines for more than a short‑term treatment period, see division 13.1.3.
(2)In this section:
short-term treatment period, for a patient to be prescribed a controlled medicine, means a consecutive 2‑month period beginning on the day the prescriber first prescribes the controlled medicine for the period.
Section 561 (1) (c) (i), except note
substitute
(i)the form, strength and the daily dose for a specified period of time; or
Section 635 (1)
omit
Minister
substitute
director-general
Section 635 (1), note 2
omit
Sections 637 and 644
omit
Minister
substitute
director-general
Section 695 (3), definition of authorised activity, new paragraph (d)
insert
(d)if the poison is integral to genuine medical or scientific research at the institution—reasonable use of the poison to carry out the research.
Section 863 (d)
substitute
(d)the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth);
New section 863 (g) to (k)
insert
(g)Australian Immunisation Handbook;
(h)Australian Technical Advisory Group on Immunisation (ATAGI) Clinical guidance on use of COVID-19 vaccine in Australia;
(i)National guidelines for medication-assisted treatment of opioid dependence;
(j)National Immunisation Education Framework for Health Professionals;
(k)National Vaccine Storage Guidelines: Strive for 5.
Section 863, new note
insert
Note 2AThe following are accessible at Australian Immunisation Handbook
· The clinical guidance on use of COVID-19 vaccine
· The National guidelines for medication-assisted treatment of opioid dependence
· The National Immunisation Education Framework for Health Professionals
· The National Vaccine Storage Guidelines: Strive for 5.
Schedule 1, part 1.11, item 1, column 3, paragraph (a) (ii)
substitute
(ii)not more than 30 ampoules, each of 1mL or less, of morphine sulphate, at a concentration of 30mg or less of morphine sulphate per mL;
(iii)not more than 5 ampoules, each of 1mL or less, of hydromorphone, at a concentration of 2mg or less of hydromorphone per mL;
Schedule 3, section 3.1, new definition of approved indication
insert
approved indication means an indication that is accepted by the Secretary of the Australian Government Department of Health in relation to the medicine in the Australian Register of Therapeutic Goods.
NoteApproved indications are shown in the public summary of the Australian Register of Therapeutic Goods on the Therapeutic Goods Administration website at >
Schedule 3, part 3.2, item 5, column 2
after
specialist area of
insert
dentistry,
Schedule 3, part 3.2, item 6, column 2
omit
designated
Schedule 3, part 3.2, new items 7 to 9
insert
| 7 | specialist practising in specialist area of dermatology, gastroenterology and hepatology, infectious diseases, paediatric gastroenterology and hepatology, paediatric infectious diseases | ivermectin | for initial treatment for an indication that is not an approved indication |
| 8 | prescriber | ivermectin | (a) for initial and continued treatment for an indication that is an approved indication; or (b) for continuation of treatment initiated by a specialist under item 7 |
| 9 | prescriber | nicotine for human use |
Schedule 3, part 3.2, new note
insert
Note 2The Poisons Standard Amendment (Hydroxychloroquine and Salbutamol) Instrument 2020 (Cwlth) (F2020L00291) commenced on 24 March 2020.
Dictionary, definition of national residential medication chart prescription
substitute
national residential medication chart prescription means a medication chart prescription within the meaning of the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth), section 41 (4), as in force from time to time.
NoteThe National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).
Endnotes
Notification
Notified under the Legislation Act on 4 November 2021.
Republications of amended laws
For the latest republication of amended laws, see align="center">© Australian Capital Territory 2021
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