Medicines, Poisons and Therapeutic Goods Amendment Regulation 2019 (No 1) (ACT)
Medicines, Poisons and Therapeutic Goods Amendment Regulation 2019 (No 1)
Subordinate Law SL2019-23
The Australian Capital Territory Executive makes the following regulation under the Medicines, Poisons and Therapeutic Goods Act 2008.
Dated 5 September 2019.
Rachel Stephen-Smith
Minister
Suzanne Orr
Minister
Medicines, Poisons and Therapeutic Goods Amendment Regulation 2019 (No 1)
Subordinate Law SL2019-23
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 30 (2), definition of restricted medicine, paragraph (b) 1
5 Section 31 (1) (e) 1
6 Section 33 2
7 Section 41 (1) (h) 2
8 Section 41 (2), except notes 2
9 Section 41 (4), definition of relevant approval particulars, paragraph (a) 2
10 Section 41 (4), definition of relevant approval particulars, paragraph (b) 2
11 Section 160 (c) 2
12 Section 250, definition of designated prescription only medicine, paragraph (b) 3
13 Section 561 (1) (c) (ii) 3
14 New section 563 (2) (aa) 3
15 New section 563 (3) and (4) 3
16 Section 571 (1) (b) (ii) 4
17 Section 575 4
18 Part 13.2 heading, note 5
19 New sections 588 and 589 5
20 Section 591 5
21 Section 592 heading 6
22 Section 592 (1) and note 6
23 Section 592 (2) 6
24 Section 592 (2) and (3) 7
25 Section 593 7
26 Section 594 (a) 8
27 Schedule 3 heading 8
28 Schedule 3, section 3.1 9
29 Schedule 3, part 3.2 10
30 Dictionary, note 3 11
31 Dictionary, new definitions 12
32 Dictionary, definitions of condition 1 etc 12
33 Dictionary, new definition of controlled medicines prescribing standards 13
34 Dictionary, definition of designated appendix D medicine 13
Name of regulation
This regulation is the Medicines, Poisons and Therapeutic Goods Amendment Regulation 2019 (No 1).
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 30 (2), definition of restricted medicine, paragraph (b)
substitute
(b)an appendix D medicine; or
Section 31 (1) (e)
substitute
(e)if the medicine is an appendix D medicine—
(i)the prescriber has an appendix D medicines approval to prescribe the medicine; and
(ii)the prescriber complies with each condition (if any) of the approval (including any conditions in schedule 3, part 3.2, column 4 in relation to the medicine).
Section 33
omit
Section 41 (1) (h)
omit
Section 41 (2), except notes
substitute
(2)However, if the prescription is written for an in-patient at a hospital in the patient’s medical records, the prescription need not include the prescriber’s professional qualifications and business address and telephone number.
Section 41 (4), definition of relevant approval particulars, paragraph (a)
omit
designated
substitute
ACT listed
Section 41 (4), definition of relevant approval particulars, paragraph (b)
omit
designated
Section 160 (c)
omit everything before subparagraph (i), substitute
(c)if the medicine is an appendix D medicine—
Section 250, definition of designated prescription only medicine, paragraph (b)
substitute
(b)an appendix D medicine; and
Section 561 (1) (c) (ii)
omit
determination
New section 563 (2) (aa)
insert
(aa)must comply with any standards determined under section 575 (Controlled medicines prescribing standards); and
New section 563 (3) and (4)
insert
(3)However, the decision of the chief health officer under section 562 need not comply with a controlled medicines prescribing standard if the decision—
(a)is in accordance with a recommendation of the medicines advisory committee that the prescribing standard not apply in the particular circumstances; or
(b)is in accordance with an entry for a controlled medicine listed in the Australian Register of Therapeutic Goods; or
(c)is necessary for the continuation of the patient’s treatment in the particular circumstances.
(4)In this section:
Australian Register of Therapeutic Goods means the register maintained under the Therapeutic Goods Act 1989 (Cwlth).
NoteThe Australian Register of Therapeutic Goods can be accessed at >
Section 571 (1) (b) (ii)
omit
determination
Section 575
substitute
Controlled medicines prescribing standards
(1)The chief health officer may determine standards setting out the circumstances in which approval may be given (the controlled medicines prescribing standards) to prescribe the following:
(a)a category of controlled medicine (a category approval);
(b)a stated form, strength or quantity of a controlled medicine.
Examples
1 approval to prescribe all forms, strengths and quantities of certain controlled medicines for people with terminal illness
2 approval to prescribe up to a stated maximum dose of a particular controlled medicine
(2)The controlled medicines prescribing standards are a notifiable instrument.
NoteA notifiable instrument must be notified under the Legislation Act.
Part 13.2 heading, note
substitute
NoteIt is a condition of an authorisation to prescribe an ACT listed appendix D medicine for the prescriber to have an approval under this part (see s 31 (1) (e)).
New sections 588 and 589
in part 13.2, insert
Modification of medicines and poisons standard—Act, s 15 (1), def medicines and poisons standard
In this regulation:
appendix D medicine—
(a)means a medicine included in the medicines and poisons standard, appendix D; but
(b)does not include a controlled medicine.
Meaning of ACT listed appendix D medicine
In this regulation:
ACT listed appendix D medicine means an appendix D medicine listed in schedule 3, part 3.2, column 3.
Section 591
substitute
Standing approval to prescribe ACT listed appendix D medicines
(1)A prescriber mentioned in schedule 3, part 3.2, column 2 is approved to prescribe an ACT listed appendix D medicine mentioned in column 3 in relation to the prescriber.
(2)However, the prescriber must only prescribe the medicine—
(a)for a purpose (if any) mentioned in schedule 3, part 3.2, column 3; and
(b)in accordance with a condition (if any) mentioned in schedule 3, part 3.2, column 4.
Example—par (b)
If sch 3, pt 3.2, col 4 includes a condition requiring a prescriber to advise a woman of child-bearing age to avoid becoming pregnant during or for a certain period after the completion of treatment, the prescriber is authorised to prescribe the medicine only if the prescriber gives the patient the advice.
Section 592 heading
substitute
Applications for CHO approval to prescribe appendix D medicines
Section 592 (1) and note
substitute
(1)A prescriber may, in writing, apply to the chief health officer for approval to prescribe an appendix D medicine.
Section 592 (2)
omit
doctor’s
substitute
prescriber’s
Section 592 (2) and (3)
omit
doctor
substitute
prescriber
Section 593
substitute
CHO decisions on applications to prescribe appendix D medicines
(1)The chief health officer must approve, or refuse to approve, an application by a prescriber under section 592 for approval to prescribe an appendix D medicine.
(2)An approval under subsection (1) to prescribe an appendix D medicine is subject to the following conditions:
(a)if the medicine is an ACT listed appendix D medicine—that the prescriber complies with any conditions in schedule 3, part 3.2, column 4 in relation to the medicine;
(b)any other condition included in the approval by the chief health officer.
Example—par (a)
If sch 3, pt 3.2, col 4 includes a condition requiring a prescriber to advise a woman of child‑bearing age to avoid becoming pregnant during or for a certain period after the completion of treatment, the prescriber is authorised to prescribe the medicine only if the prescriber gives the patient the advice.
(3)For this section, the chief health officer—
(a)must have regard to the specialist area (if any) in which the prescriber practises and the requirements (if any) stated in the medicines and poisons standard, appendix D for the medicine to which the application relates; and
(b)may have regard to anything else the chief health officer considers appropriate.
(4)The chief health officer must send the prescriber written notice of the chief health officer’s decision not later than 7 days after the day the decision is made.
Section 594 (a)
omit
doctor’s
substitute
prescriber’s
Schedule 3 heading
substitute
Schedule 3ACT listed appendix D medicines—standing approvals
(see s 31, s 41, s 160, s 591, s 592 and s 593)
Schedule 3, section 3.1
substitute
3.1Definitions—sch 3
In this schedule:
condition 1, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, means the prescriber must ensure that the possibility of pregnancy by the woman has been excluded prior to commencement of treatment.
condition 2, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, means the prescriber must advise the woman to avoid becoming pregnant during, or for a period of 1 month after the completion of, treatment.
condition 3, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, means the prescriber must advise the woman to avoid becoming pregnant during, or for a period of 3 months after the completion of, treatment.
condition 4, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, means the prescriber must advise the woman to avoid becoming pregnant during, or for a period of 24 months after the completion of, treatment.
Schedule 3, part 3.2
substitute
Part 3.2Standing approvals for ACT listed appendix D medicines
| column 1 item | column 2 prescriber | column 3 medicine | column 4 conditions (if any) |
| 1 | specialist practising in specialist area of dermatology | acitretin for human use alefacept for human use bexarotene for human use etretinate for human use isotretinoin for human oral use thalidomide for human use | conditions 1 and 4 conditions 1 and 2 conditions 1 and 4 conditions 1 and 2 conditions 1 and 2 |
| 2 | specialist practising in specialist area of endocrinology, gynaecology or obstetrics | clomiphene for human use corifollitropin alfa for human use cyclofenil for human use dinoprost for human use dinoprostone for human use follitropin alpha (recombinant human follicle‑stimulating hormone) for human use follitropin beta (recombinant human follicle‑stimulating hormone) for human use follitropin delta (recombinant human follicle‑stimulating hormone) for human use luteinising hormone for human use urofollitropin (human follicle‑stimulating hormone) for human use | |
| 3 | specialist practising in specialist area of mental health doctor employed by Territory and working under supervision of chief psychiatrist under Mental Health Act 2015 | clozapine for human use | |
| 4 | specialist physician | ambrisentan for human use acitretin for human use etretinate for human use bexarotene for human use bosentan for human use enzalutamide for human use isotretinoin for human oral use lenalidomide for human use macitentan for human use pomalidomide riociguat for human use sitaxentan for human use teriparatide for human use thalidomide for human use tretinoin for human oral use | conditions 1 and 3 conditions 1 and 4 conditions 1 and 4 conditions 1 and 2 conditions 1 and 3 conditions 1 and 3 conditions 1 and 2 conditions 1 and 2 conditions 1 and 3 conditions 1 and 2 conditions 1 and 2 conditions 1 and 3 conditions 1 and 2 conditions 1 and 2 |
NoteSpecialist includes a doctor training in a specialist area—see the dictionary.
Dictionary, note 3
insert
· medicines advisory committee
Dictionary, new definitions
insert
ACT listed appendix D medicine—see section 589.
appendix D medicine—see section 588.
Dictionary, definitions of condition 1 etc
substitute
condition 1, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, for schedule 3 (ACT listed appendix D medicines—standing approvals)—see schedule 3, section 3.1.
condition 2, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, for schedule 3 (ACT listed appendix D medicines—standing approvals)—see schedule 3, section 3.1.
condition 3, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, for schedule 3 (ACT listed appendix D medicines—standing approvals)—see schedule 3, section 3.1.
condition 4, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, for schedule 3 (ACT listed appendix D medicines—standing approvals)—see schedule 3, section 3.1.
Dictionary, new definition of controlled medicines prescribing standards
insert
controlled medicines prescribing standards—see section 575.
Dictionary, definition of designated appendix D medicine
omit
Endnotes
Notification
Notified under the Legislation Act on 12 September 2019.
Republications of amended laws
For the latest republication of amended laws, see align="center">© Australian Capital Territory 2019
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