Misuse of Drugs (Medicinal Cannabis) Regulations 2019

Reprint as at 30 September 2020

Coat of Arms of New Zealand

Misuse of Drugs (Medicinal Cannabis) Regulations 2019

(LI 2019/321)

Patsy Reddy, Governor-General

Order in Council

At Wellington this 16th day of December 2019

Present:
Her Excellency the Governor-General in Council

Note

Changes authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint.

Note 4 at the end of this reprint provides a list of the amendments incorporated.

These regulations are administered by the Ministry of Health.

These regulations are made under sections 37 and 37A of the Misuse of Drugs Act 1975 and section 105 of the Medicines Act 1981—

(a)

on the advice and with the consent of the Executive Council; and

(b)

on the recommendation and advice of the Minister of Health given in accordance with section 37A of the Misuse of Drugs Act 1975 and section 105 of the Medicines Act 1981.

Contents

1Title
2Commencement
3Purpose
4Interpretation
5Transitional, savings, and related provisions
Part 1
Minimum quality standard relating to medicinal cannabis products
Overall requirements
6Minimum quality standard imposed
7Requirements for testing with maximum limits
8Other requirements
9Testing and validation of testing method
Details of other requirements
10Shelf life and storage conditions
11Identification of cannabis
12Identification of active ingredients
13Assay limits for active ingredients
14No adulteration
15Container material
16Sources of active ingredients and cannabinoids
17Restrictions on decontamination
18Pesticides
19Labelling
20Form and dosage form
21Excipients and other ingredients
Part 2
Medicinal cannabis licences
Types of licensed activity
22Types of licensed activity
23Cultivation activity
24Nursery activity
25Research activity
26Possession for manufacture activity
27Supply activity
28Licences under other enactments
Eligibility requirements
29Individuals who are eligible to hold licences
30Bodies corporate and partnerships that are eligible to hold licences
31Eligibility of responsible person
Making and assessment of applications
32Application for licence
33Locations must have adequate security arrangements
34Fees for applications
35Other fees: licence for cultivation (or to cultivate prohibited plant)
36Other fees: licence for supply activity
37Director-General’s initial check of applications
38Director-General may verify adequate security arrangements at locations
39Director-General to ask Ministry of Justice for information about applicant
Issue and renewal of, and changes to, licences
40Decision to issue licence or to decline licence
41Review of decision to decline licence
42Director-General may impose conditions
43Issue and form of licence
44Duration of licence
45Renewal of licence
46Surrender of licence
47Certain changes not to be made without approval of Director-General
48Replacement of responsible person
49Cancellation of approval of responsible person
50Certain changes to be notified to Director-General
51Licence must be securely kept
Terms and conditions relating to authorised activities
52Activity may be carried out only in specified locations
53Activity must be carried out under control of licence holder or responsible person
54Cannabis, ingredients, and products to be dealt with responsibly
55Compliance with conditions and provisions
56Security of cannabis, ingredients, and products
57Police and Director-General to be notified of unauthorised removal, loss, or activity
58Locations must be available for inspection
59Samples taken for testing
60Destruction of cannabis, ingredients, and products
61Abandoned cannabis
Record-keeping and reporting
62Records for cultivation activity
63Records for nursery activity
64Records for research activity
65Records for possession for manufacture activity
66Records for supply activity
67Records of stocktake for any activity
68Keeping of records
69Copy of records to be provided on request
70Returns for export or supply
Suspension and cancellation of licences
71Suspension of licence
72Duration of suspension
73Effect of suspension
74Revocation of licence
75Duty to return licence when revocation takes effect
76Review of suspension or revocation
77Record of suspensions and revocations
Offences
78Offence to knowingly provide false information in application
79Offence to supply to unauthorised persons
80Offence to breach conditions
81Penalty
Notices
82Giving of notices
Part 3
Amendments to other regulations
Amendments to Medicines Regulations 1984
83Amendments to Medicines Regulations 1984
84New regulation 4A inserted (Standard for CBD products)
4AStandard for CBD products
85New regulation 45B inserted (Licences that relate to CBD products)
45BLicences that relate to CBD products
Amendments to Misuse of Drugs Regulations 1977
86Amendments to Misuse of Drugs Regulations 1977
87New regulation 3C inserted (Application to medicinal cannabis products)
3CApplication to medicinal cannabis products
88Regulation 7 amended (Import and export licences)
89Regulation 22 amended (Restriction on supply of certain controlled drugs)
Amendment to Misuse of Drugs (Industrial Hemp) Regulations 2006
90Amendment to Misuse of Drugs (Industrial Hemp) Regulations 2006
91New regulation 8A inserted (Limited supply of hemp for medicinal cannabis products)
8ALimited supply of hemp for medicinal cannabis products
Schedule 1
Transitional, savings, and related provisions
Gazette Information
Reprint notes