This regulation may be cited as the Health Legislation Amendment Regulation (No. 2) 2019.
This regulation commences on 1 July 2019.
Part 2 Amendment of Health (Drugs and Poisons) Regulation 1996
This part amends the Health (Drugs and Poisons) Regulation 1996.
4Amendment of s 78A (Approved drug–nabiximols)
(1)Section 78A, heading—
omit, insert—(2)Section 78A(1)—
omit, insert—(1)Subject to section 74(3), a person must not dispense, prescribe, supply or use a controlled drug that is medicinal cannabis unless the person—(a)is a specialist medical practitioner; or(b)is another doctor who dispenses, prescribes, supplies or uses the medicinal cannabis under an approval.Maximum penalty—80 penalty units.
(3)Section 78A(3)—
omit.
5Amendment of s 79 (Prescribing controlled drugs)
Section 79(4)(j), ‘dronabinol’—
omit, insert—medicinal cannabis
6Amendment of s 82 (Conditions of dispensing)
Section 82(2)(g), ‘dronabinol or nabiximols’—
omit, insert—medicinal cannabis
7Amendment of s 118 (Storage of controlled drugs at institutions)
(1)Section 118(1)(a) and (b)—
omit, insert—(a)if the controlled drug is medicinal cannabis—in a way that complies with the medicinal cannabis security standard; or(b)otherwise—(i)in a receptacle that complies with appendix 6 of this regulation; or(ii)in another place (a secure place) an inspector who inspects the place is reasonably satisfied is at least as secure as a receptacle mentioned in subparagraph (i).(2)Section 118(2)(a), (b) and (c)—
omit, insert—(a)if the controlled drug is medicinal cannabis—ensure the drug is stored in a way that complies with the medicinal cannabis security standard; or(b)otherwise—(i)ensure the drug is stored in the receptacle or secure place mentioned in subsection (1)(b); and(ii)always keep the receptacle or secure place locked (other than when a controlled drug is being put into or taken out of the receptacle or secure place); and(iii)ensure the key or combination to, or other way used to personally access, the receptacle or secure place can not be used by a person who is not authorised to possess a controlled drug at the institution.
8Amendment of s 119 (Storage of controlled drugs generally)
(1)Section 119(1)(a) and (b)—
omit, insert—(a)if the controlled drug is medicinal cannabis—in a way that complies with the medicinal cannabis security standard; or(b)otherwise—(i)in a receptacle that complies with appendix 6 of this regulation; or(ii)in another place (a secure place) an inspector who inspects the place is reasonably satisfied is at least as secure as a receptacle mentioned in subparagraph (i).(2)Section 119(2), ‘The’—
omit, insert—For subsection (1)(b), the
9Amendment of s 120 (Notice required if lengthy treatment with controlled drug)
(1)Section 120, heading—
omit, insert—120Request for information about treatment with controlled drug
(2)Section 120(1) and (2)—
omit, insert—(1)This section applies if the chief executive reasonably suspects a relevant practitioner has administered, dispensed, prescribed or supplied a controlled drug in the treatment of a patient.(3)Section 120(3), ‘additional’—
omit, insert—stated
(4)Section 120(3) to (5)—
renumber as section 120(2) to (4).
10Insertion of new ch 5, pt 2, div 5
Chapter 5, part 2—
insert—In this division—repealed regulation means the repealed Public Health (Medicinal Cannabis) Regulation 2017.317Existing manufacturing approvals continue
(1)This section applies if, immediately before the commencement, a person was the holder of a manufacturing approval under the repealed regulation, part 2.(2)If the manufacturing approval authorised the manufacture of a controlled drug, the person is taken to hold a controlled drug manufacturer licence under this regulation—(a)to manufacture the controlled drug; and(b)for the same term that applied to the approval immediately before the commencement; and(c)subject to a condition under the repealed regulation, section 23 that applied to the approval immediately before the commencement.(3)If the manufacturing approval authorised the manufacture of a restricted drug, the person is taken to hold a restricted drug manufacturer licence under this regulation—(a)to manufacture the restricted drug; and(b)for the same term that applied to the approval immediately before the commencement; and(c)subject to a condition under the repealed regulation, section 23 that applied to the approval immediately before the commencement.(4)This section applies despite section 22.318Existing wholesaling approvals continue
(1)This section applies if, immediately before the commencement, a person was the holder of a wholesaling approval under the repealed regulation, part 2.(2)If the wholesaling approval authorised the wholesale of a controlled drug, the person is taken to hold a controlled drug wholesaler licence under this regulation—(a)to sell the controlled drug by wholesale; and(b)for the same term that applied to the approval immediately before the commencement; and(c)subject to a condition under the repealed regulation, section 23 that applied to the approval immediately before the commencement.(3)If the wholesaling approval authorised the wholesale of a restricted drug, the person is taken to hold a restricted drug wholesaler licence under this regulation—(a)to sell the restricted drug by wholesale; and(b)for the same term that applied to the approval immediately before the commencement; and(c)subject to a condition under the repealed regulation, section 23 that applied to the approval immediately before the commencement.(4)This section applies despite section 22.(1)This section applies if a person is taken to hold a drug licence under section 317 or 318.(2)Despite section 17(1)(b), the person is not required to pay a fee for an application for the renewal of the drug licence.
11Amendment of appendix 1 (Provisions not applying to morphine or opium in compounded preparations)
Appendix 1, entry for section 120, ‘Notice required if lengthy treatment with controlled drug’—
omit, insert—Request for information about treatment with controlled drug
12Amendment of appendix 9 (Dictionary)
Appendix 9—
insert—cannabis product means a product—(a)that is or was any part of a plant of the genus Cannabis, whether living or dead; or(b)otherwise derived, wholly or in part, from any part of a plant of the genus Cannabis, whether living or dead; or(c)that has, or is intended by the manufacturer of the product to have, a pharmacological effect that is substantially similar to the pharmacological effect of a product mentioned in paragraph (a) or (b).chief health officer means the chief health officer under the Hospital and Health Boards Act 2011, section 52.medicinal cannabis means a cannabis product that is used, or is intended by the manufacturer of the product to be used, for human therapeutic purposes, whether or not the product is mentioned in the Australian Register of Therapeutic Goods.medicinal cannabis security standard means the standard made by the chief health officer called ‘Standard for security of medicinal cannabis stock’, dated July 2019 and published on the department’s website.
Part 3 Amendment of Public Health Regulation 2018
This part amends the Public Health Regulation 2018.
14Insertion of new pt 8, div 5
Part 8—
insert—49ANotifiable dust lung disease—Act, s 279AA
For section 279AA of the Act, definition notifiable dust lung disease—(a)each of the following respiratory diseases is prescribed—(i)cancer;(ii)chronic obstructive pulmonary disease, including chronic bronchitis and emphysema;(iii)pneumoconiosis, including asbestosis, coal worker’s pneumoconiosis, mixed-dust pneumoconiosis and silicosis; and(b)the type of dust prescribed is inorganic dust.49BPrescribed medical practitioners—Act, s 279AA
For section 279AA of the Act, definition prescribed medical practitioner, the prescribed class of persons is medical practitioners registered under the Health Practitioner Regulation National Law as specialist health practitioners in either of the following specialties or specialty fields—(a)occupational and environmental medicine;(b)respiratory and sleep medicine.49CPrescribed period—Act, s 279AF
For section 279AF(2) of the Act, the prescribed period is 30 days from the day the prescribed medical practitioner diagnoses the person as having a notifiable dust lung disease.
15Replacement of s 60 (Paint—Act, s 60)
Section 60—
omit, insert—(1)For section 60 of the Act, the prescribed standard is the current Poisons Standard, part 2.(2)In this section—current Poisons Standard see the Therapeutic Goods Act 1989 (Cwlth), section 52A(1).
Part 4 Amendment of Radiation Safety Regulation 2010
This part amends the Radiation Safety Regulation 2010.
17Insertion of new pt 3, div 1, hdg
Before section 10—
insert—
18Amendment of s 11 (Notification of change of circumstances—Act, s 92(2))
Section 11(a)(i)—
omit, insert—(i)if the licence holder is not a prescribed licensee—the licence holder’s name;
19Insertion of new pt 3, div 2
Part 3—
insert—(1)For section 103K(1)(a) of the Act, a person is taken to hold a use licence if the person is registered under the Health Practitioner Regulation National Law to practice in the dental profession as a dentist, other than as a student.(2)The radiation source the person is allowed to use is an intra-oral dental radiation apparatus.(3)The radiation practice the person is allowed to carry out is intra-oral dental plain radiography.(4)It is a condition of the licence that the person uses the radiation source in compliance with the ‘Code of Practice for Radiation Protection in Dentistry (2005)’ published by ARPANSA.A copy of the code mentioned in subsection (4) is available on ARPANSA’s website.14BTransport licensee—Act, s 103K
(1)For section 103K(1)(b) of the Act, a person is taken to hold a transport licence if the person holds an authority under a corresponding transport law to transport a radioactive substance.(2)The person may transport the radioactive substance into Queensland.(3)It is a condition of the licence that the person transports the radioactive substance in compliance with the ‘Code of Practice for the Security of Radioactive Sources (2019)’ published by ARPANSA.A copy of the code mentioned in subsection (3) is available on ARPANSA’s website.(4)In this section—authority includes an accreditation, approval, certification or licence.corresponding transport law means a law of another State or the Commonwealth relating to the transportation of radioactive substances.
20Amendment of s 81 (Register of licensees—Act, s 207)
(1)Section 81, after ‘about licensees’—
insert—, other than prescribed licensees,
(2)Section 81—
insert—(2)Also, for section 207(1)(f) of the Act, the register must contain the following information about a prescribed licensee whose licence has been suspended or cancelled—(a)if the licensee’s licence has been cancelled—(i)the licensee’s name; and(ii)the day the decision to cancel the licence takes effect;(b)if the licensee’s licence has been suspended and the period of suspension has not ended—(i)the licensee’s name; and(ii)the day the decision to suspend the licence takes effect; and(iii)the period of the suspension.