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NARCOTIC DRUGS REGULATION 2016 - NOTES

- made under the Narcotic Drugs Act 1967

made under the

Narcotic Drugs Act 1967

Compilation No. 10

Compilation date: 1 July 2024

Includes amendments up to: F2024L00645

Registered: 1 July 2024

About this compilation

This compilation

This is a compilation of the Narcotic Drugs Regulation 2016 that shows the text of the law as amended and in force on 1 July 2024 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

Contents

Part 1--Preliminary

1 Name

3 Authority

4 Definitions

4A Prescription of substances

4B Permitted supply

Part 2--Medicinal cannabis licences and permits

Division 1--Medicinal cannabis licences and permits

5 Application for medicinal cannabis licence--information requirements

6 Application for medicinal cannabis licence--document requirements

7 Application fee for medicinal cannabis licences

7A Application for medicinal cannabis licence--general grounds for refusal of licence

7B Matters to be specified in a medicinal cannabis licence--persons prescribed

8 Application for medicinal cannabis permit--information requirements

9 Application for medicinal cannabis permit--document requirements

10 Application fee for medicinal cannabis permit

11 Application for medicinal cannabis permit--particular grounds for refusal of permit

Division 3--Conditions of medicinal cannabis licences

17 Condition that medicinal cannabis licence holder must only use seeds, cultivars or other genetic material of cannabis plants obtained from legitimate sources

17A Condition that medicinal cannabis licence holder must give information relating to activities authorised by licence if requested

17B Condition that medicinal cannabis licence holder must retain records

17C Condition that medicinal cannabis licence holder must notify emergency services

17D Condition that medicinal cannabis licence holder must notify Secretary of certain information

17E Condition that medicinal cannabis licence holder must operate in accordance with risk management plan and standard operating procedures

17F Condition that medicinal cannabis licence holder must maintain system of security

18 Condition that medicinal cannabis licence holder employ or engage suitable staff

19 Condition that medicinal cannabis licence holder be party to certain contracts

20 Condition that medicinal cannabis licence holder notify the Secretary of certain matters

Division 4--Variation, suspension and surrender of medicinal cannabis licences and medicinal cannabis permits

Subdivision A--Variation of medicinal cannabis licences and medicinal cannabis permits

21 Circumstances in which medicinal cannabis licences and medicinal cannabis permits must not be varied

22 Application for variation of medicinal cannabis licences and medicinal cannabis permits--information requirements

23 Application for variation of medicinal cannabis licences and medicinal cannabis permits--document requirements

24 Application fee for variation of medicinal cannabis licences and medicinal cannabis permits

Subdivision B--Suspension of medicinal cannabis licences and medicinal cannabis permits

25 Suspension of medicinal cannabis licences and medicinal cannabis permits

26 Secretary may suspend medicinal cannabis licences and medicinal cannabis permits

27 Secretary may permit specified activities to occur during suspension of medicinal cannabis licences

27A Secretary may permit specified activities to occur during suspension of medicinal cannabis permits

28 Secretary to notify of proposed suspension of medicinal cannabis licences and medicinal cannabis permits

29 Effect of suspension of medicinal cannabis licences

29A Effect of suspension of medicinal cannabis permits

30 Revocation of suspension of medicinal cannabis licences and medicinal cannabis permits

31 Matters not affected by suspension of medicinal cannabis licences and medicinal cannabis permits

32 Offence and civil penalty--breach of condition of permitted activity during suspension of licence or permit

Subdivision C--Surrender of medicinal cannabis licences and medicinal cannabis permits

33 Surrender of medicinal cannabis licences and medicinal cannabis permits

34 Licence holder may surrender medicinal cannabis licences and medicinal cannabis permits

Part 3--Licensing the manufacturing of narcotic drugs

Division 1--Manufacture licences and permits

35 Application for manufacture licence--information requirements

36 Application for manufacture licence--document requirements

36A Application for manufacture licence--general grounds for refusal of licence

37 Matters to be specified in a manufacture licence--persons prescribed

38 Application for manufacture permit--information requirements

Division 2--Conditions of manufacture licences

39 Condition that manufacture licence holder employ or engage suitable staff

40 Condition that manufacture licence holder notify the Secretary of certain matters

Division 3--Variation, suspension and surrender of manufacture licences and manufacture permits

Subdivision A--Variation of manufacture licences and permits

41 Circumstances in which a manufacture licence or manufacture permit must not be varied

42 Application for variation of manufacture licence or permit--information requirements

43 Application for variation of manufacture licence or permit--document requirements

Subdivision B--Suspension of manufacture licences and permits

44 Suspension of manufacture licences and permits

45 Secretary may suspend manufacture licences and permits

46 Secretary to notify of proposed suspension of manufacture licence or permit

47 Effect of suspension of manufacture licences

47A Effect of suspension of manufacture permit

48 Revocation of suspension of manufacture licence or permit

49 Matters not affected by suspension of manufacture licence or permit

Subdivision C--Surrender of manufacture licences and permits

50 Surrender of manufacture licences and permits

51 Licence holder may surrender manufacture licence or permit

Part 4--Review of decisions

52 Reviewable decisions

Part 5--Other matters

Division 1--Inspection fees

54 Inspection fees

Division 1A--Charges

54A Classes of medicinal cannabis licences for the purposes of charge

54B Payment of charge

54C Recovery of charge

Division 2--Other matters

55 Secretary to notify States and Territories of certain matters

56 Modification of operation of Chapters 2 and 3 of the Act

Part 6--Application, saving and transitional provisions

57 Application provisions relating to the Narcotic Drugs Amendment (Cannabis) Regulations  2018

58 Application provisions relating to the Narcotic Drugs Amendment (Review Recommendations) Regulations  2019

59 Application provisions relating to the Narcotic Drugs Amendment (Fees) Regulations 2020

60 Application provisions relating to the Narcotic Drugs Amendment (Cannabis-Related Manufacture Licences and Permits) Regulations  2020

61 Application provisions relating to the Narcotic Drugs Amendment (Fees) Regulations 2021

62 Application provisions relating to the Narcotic Drugs Amendment (Medicinal Cannabis) Regulations  2021

63 Application of amendments of the Narcotic Drugs Amendment (Fees) Regulations 2023

64 Application provisions relating to the Narcotic Drugs Amendment (Fees) Regulations 2024

Schedule 1--Application fees

1 Table of fees

Endnotes

Endnote 1--About the endnotes

Endnote 2--Abbreviation key

Endnote 3--Legislation history

Endnote 4--Amendment history

 

Endnotes

Endnote 1--About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1--About the endnotes

Endnote 2--Abbreviation key

Endnote 3--Legislation history

Endnote 4--Amendment history

Abbreviation key--Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history--Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section  15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and "(md not incorp)" is added to the amendment history.

 

Endnote 2--Abbreviation key

 

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/sub-subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev ... ) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

Sub-Ch = Sub-Chapter(s)

cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

commenced or to be commenced

 

Endnote 3--Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Narcotic Drugs Regulation 2016

14 Oct 2016 (F2016L01613)

29 Oct 2016 (s 2(1) item 1)

 

Narcotic Drugs Amendment (Licence Charges) Regulation 2016

9 Dec 2016 (F2016L01894)

10 Dec 2016 (s 2(1) item 1)

--

Narcotic Drugs Amendment (Cannabis) Regulations 2018

13 Feb 2018 (F2018L00106)

14 Feb 2018 (s 2(1) item 1)

--

Narcotic Drugs Amendment (Review Recommendations) Regulations 2019

20 Nov 2019 (F2019L01485)

1 Jan 2020 (s 2(1) item 1)

--

Narcotic Drugs Amendment (Fees) Regulations 2020

10 July 2020 (F2020L00904)

15 July 2020 (s 2(1) item 1)

--

Narcotic Drugs Amendment (Cannabis-Related Manufacture Licences and Permits) Regulations 2020

20 Oct 2020 (F2020L01328)

1 Nov 2020 (s 2(1) item 1)

--

Narcotic Drugs Amendment (Fees) Regulations 2021

15 June 2021 (F2021L00757)

1 July 2021 (s 2(1) item 1)

--

Narcotic Drugs Amendment (Medicinal Cannabis) Regulations 2021

10 Dec 2021 (F2021L01751)

24 Dec 2021 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022

4 Mar 2022 (F2022L00243)

Sch 1 (items 1, 2): 31 Mar 2022 (s 2(1) item 2)

--

Narcotic Drugs Amendment (Fees) Regulations 2023

21 July 2023 (F2023L01026)

1 Aug 2023 (s 2(1) item 1)

--

Narcotic Drugs Amendment (Fees) Regulations 2024

6 June 2024 (F2024L00645)

1 July 2024 (s 2(1) item 1)

--

 

Endnote 4--Amendment history

 

Provision affected

How affected

Part 1

 

s 2.....................

rep LA s 48D

s 4.....................

am F2019L01485; F2020L00904; F2020L01328; F2021L01751; F2023L01026; F2024L00645

s 4A....................

ad F2018L00106

 

am F2019L01485

s 4B....................

ad F2021L01751

 

am F2022L00243

Part 2

 

Part 2 heading.............

rs F2021L01751

Division 1

 

s 5.....................

am F2018L00106; F2019L01485; F2021L01751

 

ed C7

s 6.....................

am F2021L01751; F2024L00645

s 7A....................

ad F2018L00106

 

rs F2019L01485

 

am F2021L01751

s 7B....................

ad F2018L00106

 

am F2019L01485

 

rs F2021L01751

s 8.....................

am F2019L01485; F2021L01751

s 9.....................

am F2019L01485

 

rs F2021L01751

s 10....................

rs F2023L01026

s 11....................

am F2016L01894; F2018L00106; F2019L01485

 

rs F2021L01751

 

am F2022L00243

Division 2................

rep F2021L01751

s 12....................

rep F2021L01751

s 13....................

rep F2021L01751

s 13A...................

ad F2018L00106

 

rs F2019L01485

 

rep F2021L01751

s 14....................

am F2018L00106; F2019L01485

 

rep F2021L01751

s 15....................

am F2018L00106

 

rep F2019L01485

s 16....................

rep F2021L01751

s 17....................

am F2019L01485

 

rep F2021L01751

Division 3

 

Division 3 heading ..........

am F2021L01751

s 17....................

ad F2021L01751

s 17A...................

ad F2021L01751

s 17B...................

ad F2021L01751

s 17C...................

ad F2021L01751

s 17D...................

ad F2021L01751

s 17E...................

ad F2021L01751

s 17F...................

ad F2021L01751

s 18....................

am F2021L01751

s 19....................

am F2018L00106; F2019L01485; F2021L01751

s 20....................

am F2018L00106; F2021L01751

 

ed C7

Division 4

 

Division 4 heading..........

am F2021L01751

Subdivision A

 

Subdivision A heading........

am F2021L01751

s 21....................

rs F2021L01751

s 22....................

am F2021L01751

s 23....................

am F2021L01751

s 24....................

am F2021L01751

 

rs F2023L01026

Subdivision B

 

Subdivision B heading........

am F2021L01751

s 25....................

am F2021L01751

s 26....................

am F2021L01751

s 27....................

rs F2021L01751

s 27A...................

ad F2021L01751

s 28....................

am F2018L00106; F2021L01751

s 29....................

rs F2021L01751

s 29A...................

ad F2021L01751

s 30....................

am F2021L01751

s 31....................

am F2021L01751

s 32....................

am F2021L01751

Subdivision C

 

Subdivision C heading........

am F2021L01751

s 33....................

am F2021L01751

s 34....................

am F2019L01485; F2021L01751

Part 3

 

Part 3 heading.............

am F2021L01751

Division 1

 

s 35....................

am F2018L00106; F2019L01485; F2020L01328; F2021L01751

s 36....................

am F2018L00106; F2024L00645

s 36AA..................

ad F2020L01328

 

rep F2021L01751

s 36A...................

ad F2018L00106

 

rs F2019L01485

s 37....................

rs F2018L00106

 

am F2019L01485

 

rs F2021L01751

s 38....................

am F2018L00106; F2021L01751

s 38A...................

ad F2020L01328

 

rep F2021L01751

Division 2

 

s 39....................

am F2021L01751

s 40....................

am F2018L00106; F2021L01751

Division 3

 

Subdivision A

 

s 41....................

rs F2021L01751

s 43A...................

ad F2020L01328

 

rep F2021L01751

Subdivision B

 

s 44....................

am F2021L01751

s 45....................

am F2021L01751

s 46....................

am F2018L00106; F2021L01751

s 47....................

rs F2021L01751

s 47A...................

ad F2021L01751

s 49....................

am F2021L01751

Subdivision C

 

s 51....................

am F2019L01485; F2021L01751

Part 4

 

s 52....................

am F2016L01894; F2020L01328; F2021L01751

Part 5

 

Division 1

 

Division 1 heading..........

rs F2020L00904

s 53....................

rep F2020L00904

s 54....................

am F2020L00904; F2021L00757; F2021L01751; F2023L01026; F2024L00645

Division 1A

 

Division 1A...............

ad F2016L01894

s 54A...................

ad F2016L01894

 

rs F2021L01751

s 54AA..................

ad F2020L01328

 

rep F2021L01751

s 54AB..................

ad F2020L01328

 

rep F2021L01751

s 54B...................

ad F2016L01894

 

rs F2020L00904

 

am F2023L01026

s 54C...................

ad F2016L01894

 

am F2020L00904

Division 2

 

s 55....................

am F2021L01751

s 56....................

ad F2018L00106

 

am F2021L01751

Part 6

 

Part 6...................

ad F2018L00106

s 57....................

ad F2018L00106

s 58....................

ad F2019L01485

s 59....................

ad F2020L00904

s 60....................

ad F2020L01328

s 61....................

ad F2021L00757

s 62....................

ad F2021L01751

s 63....................

ad F2023L01026

s 64....................

ad F2024L00645

Schedule 1

 

Schedule 1 heading..........

am F2020L00904

Schedule 1................

am F2020L00904; F2020L01328

 

rs F2021L01751

c 1.....................

am F2018L00106; F2020L00904; F2020L01328; F2021L00757; F2023L01026; F2024L00645

 

 


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