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Serial 67
Medicines,
Poisons and Therapeutic Goods Legislation Amendment Bill
2022
Ms
Fyles
A Bill for an Act to amend the Medicines, Poisons and Therapeutic Goods Act 2012 and the Medicines, Poisons and Therapeutic Goods Regulations 2014
NORTHERN TERRITORY OF AUSTRALIA
MEDICINES, POISONS AND THERAPEUTIC GOODS LEGISLATION AMENDMENT ACT 2022
____________________
Act No. [ ] of 2022
____________________
Table of provisions
37 Supply of Schedule 3 substance
38 Administration
of Schedule 3
substance
63 Administering
Schedule 4 or 8 substances under administration order – Aboriginal and
Torres Strait health practitioners, nurses, midwives and pharmacists
64 Administering
Schedule 4 or 8 substances supplied on supply order – nurses
employed at residential facilities
Subdivision
3A Administering,
supplying and possessing Scheduled substances under SSTP
70 Definitions
70A Prescribed health practitioners and healthcare workers
70B Form and content of SSTP
70C Administering, supplying and possessing Schedule 4 or 8 substance under SSTP – prescribed health practitioners
70D Administering,
supplying and possessing Schedule 3, 4 or 8 substance under SSTP –
prescribed healthcare
workers
71 Supplying
Schedule 3 substances
72 Administering
Schedule 3
substances
75 Supplying
and administering Schedule 3 substance supplied by health
practitioner
100 Administration
or supply of Schedule 8 substance to be
witnessed
Division
4A Advertising use of
pesticides
112A Definition
112B Representation by unauthorised person
112C Advertisement
to include authorisation
number
122A Schedule
4 supplier certificate of
registration
123A Schedule
3
authorisation
136A Schedule
3
authorisation
140 Prohibited
substance
authorisation
145A Conditions
– Schedule 3
authorisation
254 Approval
of SSTP
Part
9.5 Transitional
matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act
2022
299 Definitions
300 Scheduled substance treatment protocols approved before commencement
301 Transitional authority for health practitioners approved to administer Schedule 4 or 8 substance before commencement
302 Transitional authority for health practitioners approved to supply Schedule 4 or 8 substance before commencement
303 COVID-19 vaccine administration protocols approved before commencement
304 Transitional authority for persons authorised to deal with COVID-19 vaccine before commencement
305 Supply of Schedule 3 substances – authorities issued before commencement
306 Declared places
307 Offence
provisions – before and after
commencement
3A Meaning
of amphetamine
Division
1A Administering,
supplying and possessing Scheduled substances under SSTP
17A Prescribed health practitioners
17B Prescribed healthcare workers
17C Content
of
SSTP
61 Period
of retention of
registers
90 Appointed
Committee members
NORTHERN
TERRITORY OF AUSTRALIA
____________________
Act No. [ ] of 2022
____________________
An Act to amend the Medicines, Poisons and Therapeutic Goods Act 2012 and the Medicines, Poisons and Therapeutic Goods Regulations 2014
[Assented to [ ] 2022]
[Introduced [ ] 2022]
The Legislative Assembly of the Northern Territory enacts as follows:
Part
1 Preliminary
matters
1 Short
title
This Act may be cited as the Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022.
This Act commences on the day after the day on which the Administrator's assent to this Act is declared.
Part
2 Amendment of Medicines, Poisons and Therapeutic Goods Act
2012
3 Act
amended
This Part amends the Medicines, Poisons and Therapeutic Goods Act 2012.
4 Section 5 amended (Definitions)
(1) Section 5, definitions amphetamine, approved ATSI health practitioner, approved midwife, approved nurse, approved paramedic, COVID-19, COVID-19 vaccine, COVID-19 vaccine administration protocol, excluded person and Scheduled substance treatment protocol
omit
(2) Section 5
insert
approved SSTP, for Chapter 2, Part 2.3, Division 1, Subdivision 3A, see section 70.
pest authorisation, for Chapter 2, Part 2.7, Division 4A, see section 112A.
prescribed health practitioner, for Chapter 2, Part 2.3, Division 1, Subdivision 3A, see section 70.
prescribed healthcare worker, for Chapter 2, Part 2.3, Division 1, Subdivision 3A, see section 70.
Schedule 3 authorisation, see section 123A.
Schedule 4 supplier certificate of registration, see section 122A.
Scheduled substance treatment protocol, see section 70B(1).
SSTP means a Scheduled substance treatment protocol.
(3) Section 5, definition authorised purpose, paragraph (b)
omit
(4) Section 5, definition authorised purpose, paragraph (c)
omit
another
insert
a
(5) Section 5, definition certificate of registration, paragraph (b)
omit
registration.
insert
registration; or
(6) Section 5, definition certificate of registration, after paragraph (b)
insert
(c) a Schedule 4 supplier certificate of registration.
5 Section 10 amended (Meaning of unrestricted Schedule 8 substance and restricted Schedule 8 substance)
Section 10(2)
omit, insert
(2) A restricted Schedule 8 substance is a Schedule 8 substance declared under section 246(1)(b) to be a restricted Schedule 8 substance.
6 Section 11 repealed (Meaning of amphetamine)
Section 11
repeal
7 Section 21 amended (Meaning of supply and sell)
(1) Section 21(1)(b)
omit
prescription; and
insert
prescription.
(2) Section 21(1)(c)
omit
8 Section 25 amended (Meaning of nurse, midwife and related terms)
Section 25(4) and (7)
omit
9 Section 28 amended (Meaning of Aboriginal and Torres Strait Islander health practitioner and approved ATSI health practitioner)
(1) Section 28, heading
omit
and approved ATSI health practitioner
(2) Section 28(1)
omit
(1)
(3) Section 28(2)
omit
10 Section 28A amended (Meaning of paramedic and approved paramedic)
(1) Section 28A, heading
omit
and approved paramedic
(2) Section 28A(1)
omit
(1)
(3) Section 28A(2)
omit
11 Sections 37 and 38 replaced
Sections 37 and 38
repeal, insert
37 Supply of Schedule 3 substance
(1) A person commits an offence if:
(a) the person intentionally supplies a substance to another person; and
(b) the substance is a Schedule 3 substance and the person is reckless in relation to that circumstance; and
(c) the supply of the substance by the person is not authorised under this Act.
Maximum penalty: 50 penalty units.
(2) Strict liability applies to subsection (1)(c).
38 Administration of Schedule 3 substance
(1) A person commits an offence if:
(a) the person intentionally administers a substance to another person; and
(b) the substance is a Schedule 3 substance and the person is reckless in relation to that circumstance; and
(c) the administration of the substance by the person is not authorised under this Act.
Maximum penalty: 50 penalty units.
(2) Strict liability applies to subsection (1)(c).
(3) It is a defence to a prosecution for an offence against subsection (1) if the defendant believed on reasonable grounds that:
(a) the person to whom the Schedule 3 substance was administered was in danger of dying or of suffering a serious disability; and
(b) the administration of the Schedule 3 substance to that person was required to prevent the person from dying or suffering a serious disability.
Note for subsection (3)
The defendant has an evidential burden in relation to this defence (see section 43BU of the Criminal Code).
12 Section 48 amended (Supplying and administering for therapeutic use or treating addiction)
(1) Section 48, heading
omit
for therapeutic use or treating addiction
insert
in prohibited circumstances
(2) Section 48(2)
omit, insert
(2) Each of the following is a prohibited circumstance for the supply or administration of an unrestricted Schedule 8 substance:
(a) for treating a person's addiction to a substance;
(b) for another purpose prescribed by regulation.
13 Section 62 repealed (Qualified pharmacist may supply and administer Schedule 4 vaccine)
Section 62
repeal
Sections 63 to 65
repeal, insert
63 Administering Schedule 4 or 8 substances under administration order – Aboriginal and Torres Strait health practitioners, nurses, midwives and pharmacists
(1) Subject to subsection (2), if an authorised prescriber has, by administration order, authorised an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a pharmacist (the practitioner) to administer a Schedule 4 or 8 substance to another person, the practitioner may, in the course of practising in the practitioner's health profession, administer the substance to the person.
Note for subsection (1)
See section 92(1)(a)(i) to (iv) in relation to the persons to whom an authorised prescriber for a Schedule 4 or 8 substance may, by administration order, authorise the administration of the substance to.
(2) The practitioner must administer the substance in accordance with any instructions given by the authorised prescriber.
(3) A practitioner who is authorised to administer a Schedule 4 or 8 substance to a person under this section may, in the course of practising in the practitioner's health profession, possess the substance for that purpose.
64 Administering Schedule 4 or 8 substances supplied on supply order – nurses employed at residential facilities
(1) Subject to subsection (2), a nurse employed at a residential facility may, in the course of practising in the nursing profession, administer a Schedule 4 or 8 substance to a resident at the facility if:
(a) the substance was supplied by a pharmacist on a supply order issued by an authorised prescriber; and
(b) the prescriber authorised the supply of the substance for the purpose of its administration to the resident.
Notes for subsection (1)
1 Under section 92(1)(b)(ii), an authorised prescriber for a Schedule 4 or 8 substance may, by supply order, authorise the supply of the substance by a pharmacist to a nurse employed at a residential facility for administration to a resident at the facility.
2 Under section 57(1)(c)(ii), a pharmacist may supply a Schedule 4 or 8 substance on a written supply order for the substance to a nurse employed at a residential facility for administration to a resident at the facility.
(2) The nurse must administer the substance in accordance with any instructions for its administration specified by the authorised prescriber in the supply order.
(3) A nurse who is authorised to administer a Schedule 4 or 8 substance to a resident at a residential facility under this section may, in the course of practising in the nursing profession, possess the substance for that purpose.
15 Section 67 repealed (Dental therapists, dental hygienists and oral health specialists)
Section 67
repeal
16 Chapter 2, Part 2.3, Division 1, Subdivision 3A inserted
After section 69
insert
Subdivision 3A Administering, supplying and possessing Scheduled substances under SSTP
In this Subdivision:
approved SSTP means an SSTP for which an approval under section 254 is in effect.
prescribed health practitioner means a health practitioner of a type prescribed by regulation under section 70A(1).
prescribed healthcare worker means a person who is a member of a class of persons prescribed by regulation under section 70A(2).
70A Prescribed health practitioners and healthcare workers
(1) The regulations may prescribe a type of health practitioner that may be authorised under this Subdivision to administer or supply a Schedule 4 or 8 substance in accordance with an approved SSTP.
(2) The regulations may prescribe a class of persons that provide health services, other than a health practitioner, that may be authorised under this Subdivision to administer or supply a Schedule 3, 4 or 8 substance in accordance with an approved SSTP.
Note for section 70A
For the administration or supply of a Schedule 3 substance by a health practitioner, see sections 71 and 72.
(1) A Scheduled substance treatment protocol is a document setting out protocols for the administration or supply of:
(a) a Schedule 4 or 8 substance by the prescribed health practitioner, or the class of prescribed health practitioners, specified in the document in the circumstances specified in the document; or
(b) a Schedule 3, 4 or 8 substance by the prescribed healthcare worker, or the class of prescribed healthcare workers, specified in the document in the circumstances specified in the document.
(2) An SSTP must specify the following matters:
(a) the prescribed health practitioner or prescribed healthcare worker, or the class of prescribed health practitioners or prescribed healthcare workers, in relation to which it applies;
(b) if the SSTP applies to a prescribed health practitioner or a class of prescribed health practitioner – the Schedule 4 or 8 substance in relation to which it applies;
(c) if the SSTP applies to a prescribed healthcare worker or a class of prescribed healthcare worker – the Schedule 3, 4 or 8 substance in relation to which it applies;
(d) the circumstances in which the substance may be administered or supplied to another person in accordance with the SSTP, including with reference to the matters prescribed by regulation;
(e) any other matter prescribed by regulation.
(3) For subsection (2)(a), a class of prescribed health practitioners or class of prescribed healthcare workers may be identified in an SSTP by reference to one or more of the following criteria:
(a) a qualification held, or training that has been undertaken, by members of the class;
(b) the employment circumstances of members of the class;
(c) a place at which members of the class practise their health profession or provide health services;
(d) any other criteria prescribed by regulations.
Note for section 70B
An SSTP is required to be approved by the CHO under section 254 before a prescribed health practitioner or prescribed healthcare worker to which the SSTP applies may administer or supply the specified Scheduled substance in accordance with it.
70C Administering, supplying and possessing Schedule 4 or 8 substance under SSTP – prescribed health practitioners
(1) Subject to subsection (2), a prescribed health practitioner may, in the course of practising in the practitioner's health profession, administer a Schedule 4 or 8 substance to another person if:
(a) an approved SSTP for the administration of the substance applies to the practitioner; and
(b) the administration of the substance to the other person is in the circumstances specified in the approved SSTP.
(2) The prescribed health practitioner must administer the substance in accordance with the approved SSTP.
(3) Subject to subsection (4), a prescribed health practitioner may, in the course of practising in the practitioner's health profession, supply a Schedule 4 or 8 substance to another person if:
(a) an approved SSTP for the supply of the substance applies to the practitioner; and
(b) the supply of the substance to the other person is in the circumstances specified in the approved SSTP.
(4) The prescribed health practitioner must supply the substance in accordance with the approved SSTP.
(5) A prescribed health practitioner who is authorised to administer or supply a Schedule 4 or 8 substance to another person under this section may, in the course of practising in the practitioner's health profession, possess the substance for that purpose.
70D Administering, supplying and possessing Schedule 3, 4 or 8 substance under SSTP – prescribed healthcare workers
(1) Subject to subsection (2), a prescribed healthcare worker may, in the course of providing health services, administer a Schedule 3, 4 or 8 substance to another person if:
(a) an approved SSTP for the administration of the substance applies to the healthcare worker; and
(b) the administration of the substance to the other person is in the circumstances specified in the approved SSTP.
(2) The prescribed healthcare worker must administer the substance in accordance with the approved SSTP.
(3) Subject to subsection (4), a prescribed healthcare worker may, in the course of providing health services, supply a Schedule 3, 4 or 8 substance to another person if:
(a) an approved SSTP for the supply of the substance applies to the healthcare worker; and
(b) the supply of the substance to the other person is in the circumstances specified in the approved SSTP.
(4) The prescribed healthcare worker must supply the substance in accordance with the approved SSTP.
(5) A prescribed healthcare worker who is authorised to administer or supply a Schedule 4 or 8 substance to another person under this section may, in the course of providing health services, possess the substance for that purpose.
17 Sections 71 and 72 replaced
Sections 71 and 72
repeal, insert
71 Supplying Schedule 3 substances
(1) Subject to subsection (4), a health practitioner may, in the course of practising in the practitioner's health profession, supply a Schedule 3 substance to another person (the recipient).
(2) A health practitioner who supplies a Schedule 3 substance under subsection (1) must, at the time of the supply, give the recipient adequate instructions (written or oral) for the administration of the substance.
(3) The health practitioner must give the instructions to the recipient under subsection (2) even if the Schedule 3 substance that is supplied is to be used by a person other than the recipient.
(4) Subsection (1) does not authorise the sale by retail of a Schedule 3 substance by a health practitioner other than a pharmacist.
72 Administering Schedule 3 substances
A health practitioner may, in the course of practising in the practitioner's health profession, administer a Schedule 3 substance to another person.
Section 75
repeal, insert
75 Supplying and administering Schedule 3 substance supplied by health practitioner
(1) If a health practitioner has supplied a Schedule 3 substance to a person (the recipient) for use by a person other than the recipient, the recipient may supply, but not sell, the substance to the person.
(2) If a health practitioner has supplied a Schedule 3 substance for administration to a person (the patient), any person may administer the substance to the patient in accordance with the instructions given by the health practitioner.
Note for subsection (2)
See section 71 in relation to the supply of a Schedule 3 substance by a health practitioner.
19 Section 78 amended (Possessing, supplying and administering Schedule 3, 4 and 8 substances under emergency authorisation)
Section 78
omit
an authorised person
insert
a person who is authorised, or a member of a class of health practitioners that is authorised,
20 Section 84 amended (Unrestricted Schedule 8 substance – therapeutic use or treating addiction)
(1) Section 84, heading
omit
therapeutic use or treating addiction
insert
prohibited circumstances
(2) Section 84(2)(a)
omit
21 Section 92 amended (Authorised prescriber may authorise administration and supply by order)
(1) Section 92(1)(a)
omit
all words from "verbal order" to "health practitioner"
insert
oral order (an administration order), authorise the administration of the substance by an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a pharmacist
(2) Section 92, note
omit, insert
Note for section 92
An administration order or supply order may be issued electronically in accordance with the Electronic Transactions (Northern Territory) Act 2000.
22 Section 99 amended (Administering Schedule 3, 4 or 8 substance at hospital, residential facility or declared place)
(1) Section 99(2)
omit
professional
insert
practitioner
(2) Section 99(2)(c)
omit, insert
(c) does not administer the substance in accordance with the instructions of the authorised prescriber.
Section 100
repeal, insert
100 Administration or supply of Schedule 8 substance to be witnessed
(1) Subject to subsections (3) and (4), a health practitioner must not administer or supply a Schedule 8 substance to a relevant patient unless a person other than the practitioner or the patient witnesses the administration or supply of the substance.
(2) Subject to subsections (3) and (4), if a health practitioner administers or supplies a Schedule 8 substance to a relevant patient and the administration or supply of the substance is witnessed by another person, the health practitioner must record the name of at least one person who witnessed the administration or supply of the substance in the record prescribed by regulation (the prescribed record).
(3) Subsections (1) and (2) do not apply to a health practitioner if:
(a) the health practitioner is an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a pharmacist (the practitioner); and
(b) another person is not reasonably available to witness the practitioner administer or supply the Schedule 8 substance to the relevant patient because of:
(i) the remote location of the place where the substance is administered or supplied; or
(ii) other special circumstances; and
(c) the practitioner records the reason why the administration or supply of the substance was not witnessed in the relevant patient's clinical record.
(4) Subsection (1) and (2) do not apply to a health practitioner if:
(a) the health practitioner is a pharmacist; and
(b) the Schedule 8 substance that is administered or supplied to the relevant patient by the pharmacist is a restricted Schedule 8 substance; and
(c) the relevant patient is taking part in a pharmacotherapy program conducted at the hospital, residential facility or declared place.
(5) A health practitioner commits an offence if:
(a) the health practitioner administers or supplies a Schedule 8 substance to a relevant patient; and
(b) the administration or supply of the substance is required to be witnessed under subsection (1); and
(c) the administration or supply of the substance is not witnessed by a person other than the health practitioner or the relevant patient.
Maximum penalty: 20 penalty units.
(6) A health practitioner commits an offence if:
(a) the health practitioner administers or supplies a Schedule 8 substance to a relevant patient; and
(b) the administration or supply of the substance is witnessed by a person other than the health practitioner or the relevant patient; and
(c) the health practitioner is required to record the name of at least one of the persons who witnessed the administration or supply of the substance in the prescribed record under subsection (2); and
(d) the health practitioner fails to record the name of at least one of the persons who witnessed the administration or supply of the substance in the prescribed record.
Maximum penalty: 20 penalty units.
(7) An offence against subsection (5) or (6) is an offence of strict liability.
(8) In this section:
relevant patient means a person who is:
(a) a patient of a hospital; or
(b) a resident of a residential facility; or
(c) receiving medical treatment at a declared place.
24 Chapter 2, Part 2.7, Division 4A inserted
After section 112
insert
Division 4A Advertising use of pesticides
In this Division:
pest authorisation means:
(a) a pest management technician licence; or
(b) a licence granted under Part 5, Division 2 of the Agricultural and Veterinary Chemicals (Control of Use) Act 2004; or
(c) an S7 authorisation issued under the Agricultural and Veterinary Chemicals (Control of Use) Regulations 2005.
112B Representation by unauthorised person
(1) A person commits an offence if the person:
(a) represents, by any means, that the person carries out pest control operations involving the use of a pesticide for fee or reward; and
(b) is not authorised under a pest authorisation to use the pesticide.
Maximum penalty: 100 penalty units.
(2) An offence against subsection (1) is an offence of strict liability.
112C Advertisement to include authorisation number
(1) An advertisement for pest control operations that are offered by a business and involve the use of a pesticide must state:
(a) if the owner of the business holds a pest authorisation – the number of that authorisation; or
(b) otherwise – the number of the pest authorisation held by at least one person who is employed or contracted by the owner to carry out pest control operations for the business.
(2) A person commits an offence if:
(a) the person:
(i) places or distributes an advertisement for pest control operations that are offered by a business and involve the use of a pesticide; or
(ii) authorises another person to place or distribute an advertisement mentioned in subparagraph (i); and
(b) the advertisement does not state the information required under subsection (1).
Maximum penalty: 100 penalty units.
(3) An offence against subsection (2) is an offence of strict liability.
(4) In this section:
advertisement means every form of advertisement or notice, however displayed, and whether or not displayed to the public.
Examples for definition advertisement
1 A post on a social media platform.
2 A flyer on a noticeboard.
25 Section 117 amended (Types of authorities)
(1) After section 117(b)
insert
(ba) a Schedule 4 supplier certificate of registration;
(2) After section 117(c)
insert
(ca) a Schedule 3 authorisation;
26 Section 120 amended (Suitability of nominated person – certificate of registration)
Section 120(b), after "activities"
insert
or services
After section 122
insert
122A Schedule 4 supplier certificate of registration
A Schedule 4 supplier certificate of registration, for a place, is an authority that authorises its holder:
(a) to supply, but not to sell, the Schedule 4 substances stated in the certificate from the place in the course of carrying out the service of distributing the substances to health practitioners or health services; and
(b) to possess the substances for a purpose mentioned in paragraph (a).
After section 123
insert
A Schedule 3 authorisation is an authority that authorises its holder, and the persons stated in it, to supply, but not to sell, the Schedule 3 substances stated in it.
29 Section 128 amended (Prohibited substance authorisation)
(1) Section 128(1)
omit
all words from "authorisation," to "and other"
insert
authorisation issued to an authorised health practitioner (the authority holder) is an authority that authorises the authority holder, and another
(2) Section 128(3)
omit
authorisation, for etorphine,
insert
authorisation issued to a veterinarian or other person prescribed by regulation
30 Section 129 amended (Research authorisation)
Section 129(a), after "administer"
insert
or supply, but not to sell,
31 Section 130 amended (Medical kit authorisation)
Section 130(1)(a), after "administer"
insert
or supply, but not to sell,
32 Section 131 amended (Making application)
Section 131(c), after "activities"
insert
or services
33 Section 134 amended (Considering and deciding application)
(1) Section 134(2), note
omit
(2)(d)
insert
(2)(c)
(2) Section 134(2), note
omit
140(1)(e),
insert
136A(1)(b), 140(1)(f)
34 Section 135 amended (Certificate of registration)
(1) Section 135, after "activities"
insert
or services
(2) Section 135(a)(ii), after "registration"
insert
or Schedule 4 supplier certificate of registration
After section 136
insert
(1) The CHO may issue a Schedule 3 authorisation for a Schedule 3 substance only if satisfied that:
(a) the applicant, and each person to be authorised under the authority to supply the substance, is competent to:
(i) safely handle the substance; and
(ii) give instructions for the safe use of the substance when supplying it; and
(b) the security arrangements for the place where the substances are to be stored by the applicant are adequate to prevent the unlawful use or removal of the substances from the place.
(2) In considering the matters referred to in subsection (1)(a), the CHO may have regard to:
(a) the applicant's proposed policies or guidelines for supplying the substance; and
(b) whether the applicant, and each person to be authorised under the authority to supply the substance, have any appropriate training, experience or qualifications for supplying the substance.
Section 140
repeal, insert
140 Prohibited substance authorisation
(1) The CHO may issue a prohibited substance authorisation for a prohibited substance only in the circumstances mentioned in subsection (2) or (3).
(2) The CHO may issue a prohibited substance authorisation for a prohibited substance if satisfied:
(a) the applicant is an authorised health practitioner; and
(b) a person is suffering an illness for which there is a therapeutic need for treatment with the substance; and
(c) the substance is to be:
(i) administered to the person by the applicant or another authorised health practitioner to treat the illness; or
(ii) self-administered by the person to treat the illness; and
(d) the administration of the substance is justified in the circumstances because the person is suffering from symptoms unresponsive to other available treatment; and
(e) if the substance is to be self-administered:
(i) it is not reasonably practicable in the circumstances for the substance to be administered by an authorised health practitioner; and
(ii) the person is competent to properly self-administer the substance; and
(f) security arrangements for the place where the substance is to be stored are adequate to prevent the unlawful use or removal of the substance from the place.
(3) The CHO may issue a prohibited substance authorisation for a prohibited substance if satisfied:
(a) the applicant is a veterinarian or other person prescribed by regulation; and
(b) the substance is for use to sedate animals or for another use prescribed by regulation; and
(c) security arrangements for the place where the substance is to be stored are adequate to prevent the unlawful use or removal of the substance from the place.
37 Section 141 amended (Research authorisation)
Section 141(1)
omit
4
insert
3, 4
After section 145
insert
145A Conditions – Schedule 3 authorisation
(1) A Schedule 3 authorisation is subject to the condition that an authorised person who supplies a Schedule 3 substance to another person under the authority must, at the time of the supply, give the person adequate instructions (written or oral) for the use of the substance.
(2) The regulations may provide for matters relating to the content of the instructions that are required to be given in accordance with the condition imposed by subsection (1).
(3) In this section:
authorised person means the holder of the Schedule 3 authorisation and any other person stated in the authority.
39 Section 230 amended (Application of Therapeutic Goods Act as law of Territory)
Section 230
omit
Territory.
insert
Territory, and the Therapeutic Goods Act so applies as if it extended to:
(a) things done or omitted to be done by persons who are not corporations; and
(b) things done or omitted to be done in the course of trade and commerce within the limits of the Territory.
40 Section 244 amended (CHO may make code of practice)
(1) Section 244(4)
omit, insert
(4) If the CHO makes a code of practice under this section, the CHO must publish on the Agency's website the code of practice and notice of its making.
(2) Section 244(6)
omit
41 Section 245 amended (Exemption from holding Schedule 8 authorisation)
Section 245(4)(b)
omit
Gazette notice.
insert
notice published on the Agency's website.
42 Section 246 amended (Restricted Schedule 4 and 8 substances)
(1) Section 246(1)
omit
Gazette notice,
insert
notice published on the Agency's website,
(2) Section 246(1)(b)
omit
(other than an amphetamine)
(3) Section 246(1)(b), note
omit
43 Sections 247 to 250 repealed
Sections 247 to 250
repeal
44 Section 251 amended (Emergency authorisation for possessing, supplying and administering Schedule 3, 4 and 8 substances)
Section 251(1)
omit, insert
(1) The CHO may, by notice published on the Agency's website, authorise a person, or a class of health practitioners, to possess, supply or administer stated Schedule 3, 4 or 8 substances in an emergency relating to public health (an emergency authorisation).
45 Section 252 amended (Declared places)
Section 252
omit
Gazette notice,
insert
notice published on the Agency's website,
46 Section 253 amended (Approval for pharmacist to supply Schedule 8 substance or restricted Schedule 4 substances on interstate prescription)
Section 253(1)
omit
Gazette notice,
insert
notice published on the Agency's website,
Section 254
repeal, insert
(1) The CHO may approve, in writing, an SSTP if the CHO considers:
(a) the SSTP contains adequate information to satisfy the requirements specified in section 70B(2); and
(b) having regard to the matters to which the SSTP relates, it is appropriate to do so.
(2) The approval of an SSTP takes effect:
(a) on the date it is approved; or
(b) if the CHO specifies a later effective date in the approval of the SSTP – the later date.
(3) The approval of an SSTP remains in effect until the expiry of the period, not exceeding 2 years, specified by the CHO in the approval, unless it is sooner revoked.
(4) An SSTP approved under subsection (1) and the CHO's written approval of it must be published on the Agency's website as soon as practicable after the SSTP has been approved.
(5) The CHO may revoke, in writing, the approval of an SSTP.
48 Chapter 7, Part 7.2, Division 1A repealed (Dealings with COVID-19 vaccine)
Chapter 7, Part 7.2, Division 1A
repeal
49 Section 257 amended (Information relating to supply and use of substances)
Section 257(1)
omit
Gazette notice,
insert
notice published on the Agency's website,
50 Section 266 amended (Duration of appointment)
Section 266
omit
2
insert
3
51 Section 268 amended (Chairperson and deputy chairperson)
Section 268(1)(a)
omit
appointed member
insert
member
52 Section 269 amended (When member ceases to hold office)
Section 269(2)
omit
a member
insert
an appointed member
53 Chapter 9, Part 9.5 inserted
After section 298
insert
Part 9.5 Transitional matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022
In this Part:
amending Act means the Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022.
commencement means the commencement of section 3 of the amending Act.
COVID-19 vaccine means a Scheduled substance for vaccination against the Coronavirus disease named "COVID-19" by the World Health Organization.
former CVAP means a COVID-19 vaccine administration protocol that was approved under section 254B(1), as in force immediately before the commencement.
former SSTP means a Scheduled substance treatment protocol that was approved under section 254(1), as in force immediately before the commencement.
300 Scheduled substance treatment protocols approved before commencement
(1) For sections 301 and 302, a former SSTP continues in force after the commencement until the earlier of the following:
(a) the approval of the former SSTP is revoked by the CHO under subsection (2);
(b) the day that is 2 years after the commencement.
(2) The CHO may revoke, in writing, the approval of a former SSTP that continues to remain in force under subsection (1).
301 Transitional authority for health practitioners approved to administer Schedule 4 or 8 substance before commencement
(1) This section applies to an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a paramedic who was declared by Gazette notice under section 250, as in force immediately before the commencement, to be approved to administer a Schedule 4 or 8 substance stated in the notice in accordance with the former SSTP stated in the notice (an approved practitioner).
(2) Subject to subsection (3), an approved practitioner may, in the course of practising in the approved practitioner's health profession, administer the substance to another person after the commencement if the former SSTP stated in the notice for the approved practitioner continues to remain in force under section 300 at the time of the administration of the substance.
(3) The approved practitioner must administer the substance in accordance with:
(a) the former SSTP; and
(b) any conditions or limitations that were specified in the notice for the approved practitioner.
(4) An approved practitioner who is authorised to administer a Schedule 4 or 8 substance under subsection (2) may, in the course of practising in the approved practitioner's health profession, possess the substance for that purpose after the commencement.
302 Transitional authority for health practitioners approved to supply Schedule 4 or 8 substance before commencement
(1) This section applies to an Aboriginal and Torres Strait Islander health practitioner, a nurse or a midwife who was declared by Gazette notice under section 250, as in force immediately before the commencement, to be approved to supply a Schedule 4 or 8 substance stated in the notice in accordance with the former SSTP stated in the notice (an approved practitioner).
(2) Subject to subsection (3), an approved practitioner may, in the course of practising in the approved practitioner's health profession, supply the substance to another person after the commencement if the former SSTP stated in the notice for the approved practitioner continues to remain in force under section 300 at the time of the supply of the substance.
(3) The approved practitioner must supply the substance in accordance with:
(a) the former SSTP; and
(b) any conditions or limitations that were specified in the notice for the approved practitioner.
(4) An approved practitioner who is authorised to supply a Schedule 4 or 8 substance under subsection (2) may, in the course of practising in the approved practitioner's health profession, possess the substance for that purpose after the commencement.
303 COVID-19 vaccine administration protocols approved before commencement
(1) A former CVAP continues in force after the commencement until the earlier of the following:
(a) the approval of the former CVAP is revoked by the CHO under subsection (2);
(b) the effective period that was specified in the former CVAP expires;
(c) the day that is 2 years after the commencement.
(2) The CHO may revoke, in writing, the approval of a former CVAP that remains in force under subsection (1).
304 Transitional authority for persons authorised to deal with COVID-19 vaccine before commencement
(1) This section applies to a person who was authorised under section 254C(1), as in force immediately before the commencement, to possess, supply or administer a COVID-19 vaccine in accordance with the former CVAP specified in the person's authorisation (an approved person).
(2) Subject to subsection (3), an approved person continues to be authorised after the commencement to possess, supply or administer a COVID-19 vaccine in accordance with the former CVAP while it continues to remain in force under section 303.
(3) An approved person who possesses, supplies or administers a COVID-19 vaccine under subsection (2) must comply with the person's authorisation under the former CVAP.
305 Supply of Schedule 3 substances – authorities issued before commencement
A person who is authorised to administer a Schedule 3 substance to another person under a medical kit authorisation or a research authorisation that is in force immediately before the commencement is authorised to supply, but not to sell, the substance under that authority after the commencement.
A declaration made under section 252 that is in force immediately before the commencement continues in force after the commencement as if it were published on the Agency's website.
307 Offence provisions – before and after commencement
(1) Sections 37, 38, 100, 112B and 112C, as inserted by the amending Act, apply only in relation to offences committed after the commencement.
(2) Sections 37, 38 and 100, as in force before the commencement, continue to apply in relation to offences committed before the commencement.
(3) For this section, if any of the conduct constituting an offence occurred before the commencement, the offence is taken to have been committed before the commencement.
The Schedule has effect.
Part
3 Amendment of Medicines, Poisons and Therapeutic Goods Regulations
2014
55 Regulations
amended
This Part amends the Medicines, Poisons and Therapeutic Goods Regulations 2014.
56 Regulation 3 amended (Definitions)
Regulation 3
insert
amphetamine, see regulation 3A.
After regulation 3
insert
(1) An amphetamine includes:
(a) beta-aminoisopropylbenzene; and
(b) a substance structurally derived from amphetamine
or
beta-aminoisopropylbenzene by substitution
in the side chain or by ring closure (or both).
(2) Despite subregulation (1), a substance mentioned in subregulation (1)(a) or (b) is not an amphetamine when contained in a Schedule 2, 3 or 4 substance.
58 Part 2, Division 1A inserted
After regulation 17
insert
Division 1A Administering, supplying and possessing Scheduled substances under SSTP
17A Prescribed health practitioners
For section 70A(1) of the Act, the following types of health practitioner are prescribed:
(a) Aboriginal and Torres Strait Islander health practitioner;
(b) dental hygienist;
(c) dental therapist;
(d) midwife;
(e) nurse;
(f) oral health therapist;
(g) paramedic;
(h) pharmacist.
17B Prescribed healthcare workers
(1) For section 70A(2) of the Act, an orthoptist is a prescribed class of person.
(2) In this regulation:
orthoptist means a person whose name is recorded in the register of orthoptists kept by the Australian Orthoptists Registration Body Pty Ltd ACN 095 117 678.
(1) For section 70B(2)(d) of the Act, the following matters are prescribed:
(a) the indications for use of the Scheduled substance by a person;
(b) any contraindications against use of the Scheduled substance by a person;
(c) a description of any persons to whom the Scheduled substance must not be administered or supplied.
(2) For section 70B(2)(e) of the Act, an SSTP must specify the following matters:
(a) the form, strength, dose, route and frequency of administration of the Scheduled substance;
(b) any monitoring requirements after administration of the Scheduled substance to a person;
(c) any procedures or requirements in relation to documenting the administration or supply of the Scheduled substance to a person.
59 Regulation 18 amended (Record of supply or administration of Schedule 8 substance)
Regulation 18
omit
100(1A)(b)
insert
100(2)
60 Regulation 23 amended (Storage of Schedule 3 substance by authority holder)
Regulation 23(1), after "of a"
insert
Schedule 3 authorisation,
61 Regulation 42 amended (Contents of authority)
(1) Regulation 42(d)
omit
(2) Regulation 42(i)
omit
person.
insert
person;
(3) After regulation 42(i)
insert
(j) for a pest management technician licence – the holder's date of birth.
62 Part 4, Division 1, Subdivision 6 heading amended (Manufacturer/wholesaler register)
Part 4, Division 1, Subdivision 6, heading
omit
Manufacturer/wholesaler
insert
Manufacturer/wholesaler/Schedule 4 supplier
Regulation 61
repeal, insert
61 Period of retention of registers
(1) A Scheduled substance register, other than a register in relation to Schedule 7 substances, must be kept for at least 2 years after the day on which the last entry is made in the register.
(2) A register in relation to Schedule 7 substances must be kept for at least 7 years after the day on which the last entry is made in the register.
64 Regulations 87A and 88 repealed
Regulations 87A and 88
repeal
Regulation 90
repeal, insert
90 Appointed Committee members
For section 265 of the Act, the following are the qualification requirements for appointed members of the Committee:
(a) 2 members must be doctors with expertise in pain management or rehabilitation;
(b) 2 members must be doctors with experience in general practice;
(c) one member must be a doctor who is employed in the Agency and working in the community drugs program managed by the Agency;
(d) one member must be a person who is employed in the Agency and working in the community drugs program managed by the Agency but who is not a doctor;
(e) one member must be a pharmacist with experience in the community pharmacy practice area;
(f) one member must be a pharmacist with experience in the hospital or clinical pharmacy practice area;
(g) any other appointed member must be:
(i) a health practitioner; or
(ii) a veterinarian; or
(iii) a lawyer; or
(iv) a person who is employed in the Agency and working in the community drugs program managed by the Agency but who is not a doctor.
Schedule 1
omit
|
sections 97(2) and (3), 107(1) and 176(1) and
(2)
|
1
|
|
insert
|
sections 97(2) and (3) and 107(1)
|
1
|
|
|
sections 112B(1) and 112C(2)
|
3
|
|
|
section 176(1) and (2)
|
1
|
|
(1) Schedule 2, after item 1(b)
insert
|
|
(ba) Schedule 4 supplier certificate of
registration
|
50 plus 100 for each year the certificate will be in
force
|
(2) Schedule 2, after item 1(c)
insert
|
|
(ca) Schedule 3 authorisation
|
50 for each year the authorisation will be in
force
|
(3) Schedule 2, after item 2(b)
insert
|
|
(ba) Schedule 4 supplier certificate of
registration
|
100 for each year the certificate will be in force
after renewal
|
Part 4 Repeal
of
Act
68 Repeal
of Act
This Act is repealed on the day after it commences.
Schedule Medicines, Poisons and Therapeutic Goods Act 2012 further amended
section 54
|
Provision
|
Amendment
|
|
|---|---|---|
|
|
omit
|
insert
|
|
section 61, heading
|
verbal
|
oral
|
|
section 61(1)(a)
|
verbally
|
orally
|
|
Chapter 2, Part 2.3, Division 1, Subdivision 3,
heading
|
and health-related occupations
|
|
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