Source: http://www.legislation.govt.nz/regulation/public/2019/0321/latest/whole.html
Timestamp: 2020-05-29 23:51:32
Document Index: 770332752

Matched Legal Cases: ['art 2', 'art 1', 'art 1', 'art 4', 'art 2', 'art 3', 'art 1', 'art 1', 'art 2', 'art 1', 'art 2', 'art 3', 'art 3']

Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (LI 2019/321) – New Zealand Legislation
These regulations are made under sections 37 and 37A of the Misuse of Drugs Act 1975 and section 105 of the Medicines Act 1981—
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.
Minimum quality standard relating to medicinal cannabis products
6 Minimum quality standard imposed
7 Requirements for testing with maximum limits
9 Testing and validation of testing method
Details of other requirements
10 Shelf life and storage conditions
11 Identification of cannabis
12 Identification of active ingredients
13 Assay limits for active ingredients
14 No adulteration
15 Container material
16 Sources of active ingredients and cannabinoids
17 Restrictions on decontamination
19 Labelling
20 Form and dosage form
21 Excipients and other ingredients
Types of licensed activity
22 Types of licensed activity
23 Cultivation activity
24 Nursery activity
25 Research activity
26 Possession for manufacture activity
27 Supply activity
28 Licences under other enactments
29 Individuals who are eligible to hold licences
30 Bodies corporate and partnerships that are eligible to hold licences
31 Eligibility of responsible person
32 Application for licence
33 Locations must have adequate security arrangements
34 Fees for applications
35 Other fees: licence for cultivation (or to cultivate prohibited plant)
36 Other fees: licence for supply activity
37 Director-General’s initial check of applications
38 Director-General may verify adequate security arrangements at locations
39 Director-General to ask Ministry of Justice for information about applicant
Issue and renewal of, and changes to, licences
40 Decision to issue licence or to decline licence
41 Review of decision to decline licence
42 Director-General may impose conditions
43 Issue and form of licence
44 Duration of licence
45 Renewal of licence
46 Surrender of licence
47 Certain changes not to be made without approval of Director-General
48 Replacement of responsible person
49 Cancellation of approval of responsible person
50 Certain changes to be notified to Director-General
51 Licence must be securely kept
52 Activity may be carried out only in specified locations
53 Activity must be carried out under control of licence holder or responsible person
54 Cannabis, ingredients, and products to be dealt with responsibly
55 Compliance with conditions and provisions
56 Security of cannabis, ingredients, and products
57 Police and Director-General to be notified of unauthorised removal, loss, or activity
58 Locations must be available for inspection
59 Samples taken for testing
60 Destruction of cannabis, ingredients, and products
61 Abandoned cannabis
62 Records for cultivation activity
63 Records for nursery activity
64 Records for research activity
65 Records for possession for manufacture activity
66 Records for supply activity
67 Records of stocktake for any activity
68 Keeping of records
69 Copy of records to be provided on request
70 Returns for export or supply
71 Suspension of licence
72 Duration of suspension
73 Effect of suspension
74 Revocation of licence
75 Duty to return licence when revocation takes effect
76 Review of suspension or revocation
77 Record of suspensions and revocations
78 Offence to knowingly provide false information in application
79 Offence to supply to unauthorised persons
80 Offence to breach conditions
82 Giving of notices
Amendments to Medicines Regulations 1984
83 Amendments to Medicines Regulations 1984
84 New regulation 4A inserted (Standard for CBD products)
4A Standard for CBD products
85 New regulation 45B inserted (Licences that relate to CBD products)
45B Licences that relate to CBD products
Amendments to Misuse of Drugs Regulations 1977
86 Amendments to Misuse of Drugs Regulations 1977
87 New regulation 3C inserted (Application to medicinal cannabis products)
3C Application to medicinal cannabis products
88 Regulation 7 amended (Import and export licences)
89 Regulation 22 amended (Restriction on supply of certain controlled drugs)
Amendment to Misuse of Drugs (Industrial Hemp) Regulations 2006
90 Amendment to Misuse of Drugs (Industrial Hemp) Regulations 2006
91 New regulation 8A inserted (Limited supply of hemp for medicinal cannabis products)
8A Limited supply of hemp for medicinal cannabis products
These regulations are the Misuse of Drugs (Medicinal Cannabis) Regulations 2019.
The purpose of these regulations is to enable the research, manufacture, and supply of medicinal cannabis products and related ingredients, and the cultivation of cannabis for the products and ingredients, by providing for—
a minimum quality standard relating to the cannabis, ingredients, and products; and
a licensing regime that ensures that cannabis intended for other purposes is not cultivated and supplied under the guise of this purpose.
active ingredient means each of the following ingredients in a cannabis-based ingredient or medicinal cannabis product:
delta-9-tetrahydrocannabinol and its corresponding acid:
cannabidiol and its corresponding acid:
any other ingredient that is derived from cannabis and whose stated content is at least 1.0% by weight or volume of the ingredient or product
batch means a production-scale quantity of any cannabis-based ingredient or medicinal cannabis product that—
is made during a single cycle of manufacture; and
has a uniform composition, method of manufacture, and probability of chemical or microbial contamination
cannabis means—
any part of any plant of the genus Cannabis; and
any fruit or seed of such a plant
cannabis-based ingredient means an ingredient that—
is extracted from cannabis; and
is intended to be used in, or for, a dosage product
dosage product means a medicinal cannabis product covered by paragraph (a)﻿(ii) of the definition of that term
dried product means a medicinal cannabis product covered by paragraph (a)﻿(i) of the definition of that term
European Pharmacopoeia means the 10th edition of the European Pharmacopoeia, including supplement 10.1, as published at 1 April 2020
medicinal cannabis licence or licence means a licence issued under Part 2
medicinal cannabis product means a product—
is dried cannabis; or
contains 1 or more cannabis-based ingredients and is in a pharmaceutical dosage form (such as a tablet, a capsule, or an oral liquid); and
that contains no prescription medicine (as defined by section 3 of the Medicines Act 1981) or controlled drug other than cannabis or a cannabis-based ingredient; and
whose purpose is therapeutic, rather than recreational or anything else
minimum quality standard means the minimum quality standard imposed by Part 1
starting material means fresh or dried cannabis that is intended to be used in, or for, a medicinal cannabis product
stated content means an ingredient’s quantity in, or proportion of, a cannabis-based ingredient or medicinal cannabis product that is stated by the label, packaging, or description that accompanies the ingredient or product
therapeutic means intended to prevent, diagnose, monitor, alleviate, treat, cure, or compensate for a disease, ailment, defect, or injury in a person
type of licensed activity, for a medicinal cannabis licence, means a type of licensed activity described by regulation 22.
Part 1 Minimum quality standard relating to medicinal cannabis products
This Part imposes a minimum quality standard that the following must comply with:
any starting material that is intended for export:
a cannabis-based ingredient:
a medicinal cannabis product, whether a dried product or dosage product.
However, a cannabis-based ingredient or medicinal cannabis product need not comply with the minimum quality standard if—
it is supplied under a medicinal cannabis licence for a supply activity, and procured under a medicinal cannabis licence for a research activity, for the purpose of being administered to a person who is a research subject; or
it is a medicine whose sale, supply, use, or distribution has received the consent or provisional consent of the Minister in accordance with the Medicines Act 1981; or
it is prescribed, supplied, or administered—
by a medical practitioner for the treatment of a particular patient currently under their care; and
with the approval of the Minister under regulation 22 of the Misuse of Drugs Regulations 1977; or
it is imported by a pharmacist for a prescription to which paragraph (c) applies.
The table in this regulation sets out—
which of the following items, or categories of those items, must be tested:
starting material that is intended for export:
cannabis-based ingredients:
medicinal cannabis products, whether dried products or dosage products; and
what the items, or categories of items, must be tested for; and
the chapter or chapters of the European Pharmacopoeia that set out the testing method that must be used; and
the maximum limit that the test result must not exceed (where any chapter reference is to the European Pharmacopoeia); and
whether the testing method must be validated under regulation 9(2).
In the following table, ppm means parts per million:
All Microbiological contamination Chapters 2.6.12, 2.6.13, and 2.6.31 The limits specified by chapters 5.1.4 and 5.1.8 Yes
All Heavy metals Chapter 2.4.27
3.0 ppm of arsenic
0.5 ppm of cadmium
5.0 ppm of lead
0.5 ppm of mercury
Cannabis-based ingredient, or medicinal cannabis product, that is imported Pesticides Chapter 2.8.13 The limits specified for each pesticide specified by chapter 2.8.13 Yes
Starting material for export, cannabis-based ingredient, or medicinal cannabis product, that is not imported Pesticides Chapter 2.8.13
0.020 ppm of Abamectin
0.020 ppm of Bifenazate
0.100 ppm of Bifenthrin
0.010 ppm of Chlormequat chloride
0.020 ppm of Daminozide
0.020 ppm of Etoxazole
0.020 ppm of Fenoxycarb
0.010 ppm of Imazalil
0.020 ppm of Imidacloprid
0.020 ppm of Myclobutanil
0.020 ppm of Paclobutrazol
0.050 ppm of Pyrethrins (I and II)
0.010 ppm of Spinosad (Spinosyn A and Spinosyn D)
3.000 ppm of Spiromesifen
0.020 ppm of Spirotetramat
0.020 ppm of Trifloxystrobin
All Absence of aflatoxins Chapter 2.8.18
2 µg/kg of aflatoxin B1
4 µg/kg for the sum of aflatoxins B1, B2, G1, and G2
All Ochratoxin A Chapter 2.8.22 20 µg/kg Yes
Starting material for export or dried product Foreign matter Chapter 2.8.2 2% No
Starting material for export or dried product Loss on drying Chapter 2.2.32 10% No
Starting material for export or dried product Total ash Chapter 2.4.16 20% No
Cannabis-based ingredient or dosage product Residual solvents Chapters 2.4.24 and 5.4 The limits specified by chapter 5.4 Yes
which of the following items must comply with a requirement:
the name of the requirement; and
the regulation that sets out the requirement; and
for a requirement that involves testing, whether the requirement’s testing method must be validated under regulation 9(2).
Items that must comply
Regulation with requirement
Cannabis-based ingredient or any medicinal cannabis product Shelf life and storage conditions r 10 –
Starting material for export or dried product Identification of cannabis r 11 No
Cannabis-based ingredient or any medicinal cannabis product Identification of active ingredients r 12 Yes
Cannabis-based ingredient or any medicinal cannabis product Assay limits for active ingredients r 13 Yes
All No adulteration r 14 –
Cannabis-based ingredient or any medicinal cannabis product Container material r 15 –
Any medicinal cannabis product Sources of active ingredients and cannabinoids r 16 –
All Restrictions on decontamination r 17 –
All Pesticides r 18 –
Any medicinal cannabis product Labelling r 19 –
Any medicinal cannabis product Form and dosage form r 20 Yes
Dosage product Excipients and other ingredients r 21 No
Any testing required by regulation 7, or by a requirement covered in regulation 8, must be carried out by a GMP-certified manufacturer or laboratory.
If regulation 7 or 8 requires the testing method to be validated, it must be validated by a GMP-certified manufacturer or laboratory.
In this regulation, GMP-certified means certified by the following as complying with the requirements of good manufacturing practice set out in the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods:
an authority in another country that the Director-General recognises as a certifier of the compliance.
A cannabis-based ingredient or medicinal cannabis product must remain compliant with the requirements of this minimum quality standard relating to the following during its shelf life:
assay limits for active ingredients:
Stability testing must be done on the ingredient or product in accordance with the ICH Q1A Guideline to determine its—
In this regulation, ICH Q1A Guideline means the Q1A(R2) Guideline on Stability Testing of New Drug Substances and Products published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, as published at 1 April 2020.
The following must be positively identified as cannabis by using both macroscopic and microscopic examination:
a dried product.
The active ingredients in the following must be positively identified by using chromatographic or spectroscopic methods, or both:
a medicinal cannabis product (including a dried product).
This regulation applies to a cannabis-based ingredient or medicinal cannabis product.
Each active ingredient in the ingredient or product must be assayed using chromatographic or spectroscopic methods.
For a dried product, each active ingredient must assay at—
no less than 80% of its stated content; and
no more than 120% of its stated content.
For a cannabis-based ingredient or dosage product, each active ingredient must assay at—
no less than 90% of its stated content; and
no more than 110% of its stated content.
The following must not contain any substance that adulterates it:
a medicinal cannabis product.
In this regulation, adulterate means to add or substitute any substance that is extraneous to the composition of the material, ingredient, or dried product, or the formulation of the dosage product, other than incidental minor excipients, whether or not the intention is to improve, fortify, or debase the material, ingredient, or product.
A cannabis-based ingredient or medicinal cannabis product must be packed in a container of a material that complies with chapters 3.1 and 3.2 of the European Pharmacopoeia.
The following ingredients contained in a medicinal cannabis product must be extracted only from cannabis:
an active ingredient:
a cannabinoid.
Any treatment to decontaminate any of the following must not adversely affect the quality of the material, ingredient, or product, or use or contain ethylene oxide:
an ingredient of a medicinal cannabis product.
The following must not have been treated with a pesticide unless the pesticide is a trade name product that is registered under the Agricultural Compounds and Veterinary Medicines Act 1997 for use on cannabis:
cannabis from which a cannabis-based ingredient is extracted:
A medicinal cannabis product that is a medicine must comply with the requirements relating to a medicine in Part 4 of the Medicines Regulations 1984, but with the following modifications:
that Part applies as if active ingredient had the same meaning as it has in these regulations:
regulations 23 and 13(1)﻿(k)﻿(i) and (l) of those regulations do not apply (meaning that the rest of regulation 13, and regulations 16(1) and 22, of those regulations always apply to the product):
regulation 16(1) of those regulations applies as if it also required the principal display panel of the product’s label to contain the words “MEDICINAL CANNABIS PRODUCT” .
A medicinal cannabis product must not be in a form intended for smoking.
A dosage product—
must be in a pharmaceutical dosage form for which there is a monograph in the European Pharmacopoeia; and
must comply with the requirements of the monograph; but
must not be in a sterile dosage form.
A dosage product must not contain an excipient for which there is no monograph in the European Pharmacopoeia.
The dosage product must comply with the requirements of the monograph in the European Pharmacopoeia for each excipient that it contains.
The dosage product must not contain an ingredient that—
is derived from an animal; and
is contaminated with any transmissible spongiform encephalopathy.
Part 2 Medicinal cannabis licences
A medicinal cannabis licence authorises the licence holder to carry out 1 or more of the following types of licensed activity:
a cultivation activity:
a nursery activity:
a research activity:
a possession for manufacture activity:
a supply activity.
A cultivation activity means any activity listed in subclause (2) that—
is specified in the licence; and
is done for a purpose relating to—
the cultivation of cannabis for therapeutic use; and
if specified in the licence, the cultivation of only approved cultivars under the Misuse of Drugs (Industrial Hemp) Regulations 2006.
to cultivate cannabis:
to procure the following within New Zealand:
any cannabis from the holder of a medicinal cannabis licence that authorises its supply:
no more than 50 seeds and 20 plants from each holder of a licence issued under the Misuse of Drugs (Industrial Hemp) Regulations 2006 that authorises their supply:
no more than 50 seeds and 20 plants (from any other source) of a variety of cannabis that is established in New Zealand and that the applicant has declared under regulation 35:
to procure cannabis by import into New Zealand under a licence to import controlled drugs issued under the Misuse of Drugs Regulations 1977:
to produce starting material, including by harvesting or drying cannabis:
to supply cannabis within New Zealand to a person who is authorised to receive it by any enactment or a medicinal cannabis licence for a cultivation, nursery, research, possession for manufacture, or supply activity:
to possess cannabis.
A nursery activity means any activity listed in subclause (2) that—
is done for a purpose relating to the supply of cannabis seeds or plants for cultivation for therapeutic use.
to procure cannabis—
within New Zealand from the holder of any medicinal cannabis licence that authorises its supply; or
by import into New Zealand under a licence to import controlled drugs issued under the Misuse of Drugs Regulations 1977:
to supply cannabis seeds and plants within New Zealand to a person who is authorised to receive it by any enactment or a medicinal cannabis licence for a cultivation activity:
A research activity means any activity listed in subclause (2) that—
is done for a purpose relating to research about cannabis for therapeutic use.
to procure any starting material, cannabis-based ingredient, or medicinal cannabis product—
to produce or manufacture a cannabis-based ingredient or medicinal cannabis product:
to supply or administer a medicinal cannabis product to a person who is a research subject:
to possess any starting material, cannabis-based ingredient, or medicinal cannabis product.
A possession for manufacture activity means any activity listed in subclause (2) that—
is done for a purpose relating to production or manufacture from cannabis for therapeutic use.
any of the following manufacturing activities, but only to develop or test the related processes or products or to validate that testing:
extracting a cannabis-based ingredient:
manufacturing or packing a medicinal cannabis product:
testing any cannabis or medicinal cannabis product:
A supply activity means any activity listed in subclause (2) that—
is done for a purpose relating to the supply of—
any starting material not intended for export; or
any starting material intended for export, cannabis-based ingredient, or medicinal cannabis product that is specified in the licence.
to supply any starting material, cannabis-based ingredient, or medicinal cannabis product within New Zealand to a person who is authorised to receive it under 1 of the following:
any enactment:
a medicinal cannabis licence:
a licence issued under the Misuse of Drugs Regulations 1977:
a licence issued under the Medicines Act 1981:
to supply any starting material, cannabis-based ingredient, or medicinal cannabis product by export from New Zealand under a licence to export controlled drugs issued under the Misuse of Drugs Regulations 1977:
A medicinal cannabis licence does not remove any need for its holder to also hold any of the following relevant licences:
a licence to manufacture medicines, a licence to pack medicines, a licence to sell medicines by wholesale, or a licence to sell medicines by retail issued under the Medicines Act 1981 (see section 109 of that Act):
a licence to import controlled drugs, or a licence to export controlled drugs, issued under the Misuse of Drugs Regulations 1977.
A medicinal cannabis licence does not affect—
any of those licences; or
any other licence issued under the Medicines Act 1981; or
any other licence issued under the Misuse of Drugs Regulations 1977; or
any licence issued under the Misuse of Drugs (Industrial Hemp) Regulations 2006.
This regulation is for the avoidance of doubt.
has completed an application for the licence; and
satisfies both of the following, or does not satisfy both of the following but is approved by the Minister:
they have never held a licence issued under the Misuse of Drugs Act 1975, or any regulations made under that Act, that has been revoked:
they have never been convicted of an offence against the Misuse of Drugs Act 1975 or any other drug-related offence; and
is entitled to use the location or locations specified in the application for the licence for the types of licensed activity sought; and
is familiar with, and has the expertise and the resources to comply with, the obligations that these regulations impose on the holder of a licence for the types of licensed activity sought.
A body corporate or partnership (an entity) is eligible to hold a licence if—
an application for the licence has been completed for the entity by a person authorised to do so; and
every director or partner of the entity is 18 years or older; and
both of the following are satisfied, or both of the following are not satisfied but the entity is approved by the Minister:
neither the entity, nor any director or partner of the entity, has held a licence issued under the Misuse of Drugs Act 1975, or any regulations made under that Act, that has been revoked:
neither the entity, nor any director or partner of the entity, has been convicted of an offence against the Misuse of Drugs Act 1975 or any other drug-related offence; and
the body corporate is incorporated in New Zealand or the partners of the partnership reside in New Zealand; and
the entity is entitled to use the location or locations specified in the application for the licence for the types of licensed activity sought; and
the entity has nominated 1 or more individuals to be responsible persons, being individuals who are eligible under regulation 31; and
1 or more directors or partners of the entity have the expertise, and the entity has the resources,—
to comply with the obligations that these regulations impose on the holder of a licence for the types of licensed activity sought; and
to carry out the types of licensed activity for which the licence is sought.
is authorised by the entity concerned to control the activities for which the licence is sought, and to communicate with the Director-General on behalf of the entity; and
is familiar with, and has the expertise to comply with, the obligations that these regulations impose on the holder of a licence for the types of licensed activity sought; and
An application for a licence must be in a form provided by the Director-General.
The form must require the following:
the name of every director or partner; and
the name, address, and contact details of each person nominated to be a responsible person:
the 1 or more types of licensed activity to be added to the licence:
a declaration from each person nominated to be a responsible person that they are eligible under regulation 31.
The form must also require the following information for each type of licensed activity for which the licence is sought:
the following information about the location or locations to be used for the activity:
the geographical co-ordinates:
a plan or map, if required to identify a location:
the details of adequate arrangements for physical and procedural security, and the security of staff members, at the location or locations of the activity:
the details of standard operating procedures for the activity, including for—
tracking and recording any starting material, cannabis-based ingredient, or medicinal cannabis product; and
destroying waste material:
the place where the records of the activities will be kept:
adequate additional information to enable the Director-General to assess whether the applicant is eligible to hold a licence for the activity:
the additional information specified for the activity (if any) by the following table:
Type of licensed activity
Whether the cannabis to be cultivated is only approved cultivars under the Misuse of Drugs (Industrial Hemp) Regulations 2006.
Whether the purpose of the activity is to cultivate cannabis for a nursery, research, possession for manufacture, or supply activity.
Evidence to satisfy the Director-General that the applicant—
holds, or has applied for, a licence for a nursery, possession for manufacture, or supply activity; or
has an agreement to supply cannabis to the holder of a licence for a cultivation, nursery, possession for manufacture, or supply activity.
A detailed description of the research proposal.
Details of the manufacturing activities described by regulation 26(2)﻿(b) that are to be carried out.
Details of each consignment of starting material for export, or each cannabis-based ingredient or medicinal cannabis product, to be supplied.
For each consignment of starting material for export to be specified in the licence, evidence (including the results of all required testing) to satisfy the Director-General that a representative sample of the consignment complied with the minimum quality standard.
For each cannabis-based ingredient or medicinal cannabis product to be specified in the licence, evidence (including the results of all required testing) to satisfy the Director-General that a representative sample of at least 10% of each of 3 batches of the ingredient or product complied with the minimum quality standard.
The following information for each cannabis-based ingredient or medicinal cannabis product to be specified in the licence:
evidence (if any exists) that approval of, or consent to, its distribution in any country other than New Zealand has been given, or declined, by the appropriate authorities in that country:
its trade name, which—
must be unique (whether proprietary, non-proprietary, or a word or code); and
must not be misleading about its therapeutic effects, safety, or composition; and
must not cause confusion with another medicine in New Zealand:
a full-scale colour image, or (if requested) a physical specimen, of every label or description that will accompany it:
a full statement of its composition, or its formulation (meaning its ingredients and the quantity or proportion of each ingredient):
details of its method of manufacture (including packing and testing):
details of its container closure system:
evidence that the facilities for its manufacture (including packing and testing) are GMP-certified (as defined by regulation 9):
a detailed recall plan:
details of the recommended method of administering, applying, or using it.
Every address specified in the application must be in New Zealand.
The locations specified in an application must have the adequate security arrangements described in the application.
This regulation applies to an application for a new licence or to renew a licence (see regulation 47 for a change to a licence while it is in force).
The following table sets out—
the types of application for which 1 or more fees are payable:
the fee payable for the initial check of whether an application appears to be in order:
if the initial check confirms that an application for a new licence, or addition of a new type of licensed activity to a licence, or both, appears to be in order,—
the fee payable for consideration of an application for a new licence:
the fee payable for consideration of an application to add each new type of licensed activity:
if the initial check confirms that an application to renew a licence, or to renew a type of licensed activity for a renewed licence, or both, appears to be in order,—
the fee payable for consideration of an application to renew a licence:
the fee payable for consideration of an application to renew each type of licensed activity:
Fee for initial check
Fee for consideration if new
Fee for consideration if renewal
Anything (licence and any activities) $300
Licence $2,250 $2,250
Cultivation activity $4,750 $2,950
Nursery activity $650 $650
Research activity – –
Possession for manufacture activity $2,700 $2,300
Supply activity $5,550 $5,150
If someone applies for a new licence for a cultivation and supply activity, they must initially pay $300 for the initial check of the application.
If the initial check confirms that the application appears to be in order, the applicant must then pay $12,550, comprising—
If the application is for supply of a new dosage product, the applicant must also pay a further $13,400 under regulation 36.
All fees are specified exclusive of GST.
The fee for the initial check must be paid when the application is submitted.
The other fees under these regulations must be paid only if the initial check confirms that the application appears to be in order.
The Director-General may waive or refund any fee under these regulations, in whole or part and in any particular case or class of cases, if satisfied that the waiver or refund—
will better match the fees paid with the costs of the services for which they are paid; or
This regulation applies when a person—
is applying for a cultivation activity in relation to a medicinal cannabis licence; or
holds a medicinal cannabis licence for a cultivation activity; or
holds a licence to cultivate a prohibited plant, for scientific or research purposes, that was issued under the Misuse of Drugs Regulations 1977 and held at the commencement of these regulations.
The person may declare in writing that, in accordance with the licence, they will procure no more than 50 seeds and 20 plants of a variety of cannabis that is established in New Zealand.
However, the person can make more than 1 declaration for each variety of cannabis.
The person must pay a fee of $650, exclusive of GST, when providing each declaration.
For a licence described by subclause (1)﻿(c), on the making of the declaration, the licence is treated as permitting the holder to possess and cultivate the declared seeds and plants, despite any condition in the licence.
This regulation applies when an applicant is applying for a supply activity in respect of any of the following that are not already specified in their licence (or in the licence that they are renewing):
a consignment of starting material for export:
The applicant must pay the fee specified in the following table (exclusive of GST) for the assessment of the consignment of starting material, or the ingredient or product, under regulation 40(5):
Fee for assessment
Consignment of starting material for export $5,250
Cannabis-based ingredient $6,700
Dried product $6,700
Dosage product $13,400
To avoid doubt, the fee for assessment of a dosage product also covers the assessment of its cannabis-based ingredients.
On receipt of an application, the Director-General must check whether the application appears to be in order.
If the application does not appear to be in order, the Director-General must return the application to the applicant and advise them that—
the application is incomplete and that a new application will be required; or
they do not appear to be eligible to hold the licence sought.
The Director-General may inspect every location specified in the application to verify that it has the adequate security arrangements described in the application.
In order to ascertain whether an applicant, any director or partner of an applicant, or any individual nominated as a responsible person has a conviction for a crime or an offence referred to in this Part, the Director-General must ask the chief executive of the Ministry of Justice to check whether the person has a conviction of that type.
approves at least 1 nominated individual as a responsible person; and
is satisfied that the activities for which the licence is sought are intended to be done for the proper purpose of those types of licensed activity; and
is satisfied that every location specified in the application has the adequate security arrangements described in the application; and
is satisfied with the information described in regulation 32(3) that is provided in the application.
If, after considering an application, the Director-General is not satisfied about any of those matters or does not approve at least 1 nominated individual as a responsible person, the Director-General must decline the application.
In deciding whether to approve an application, the Director-General may have regard to whether the applicant, any director or partner of the applicant, or any individual nominated as a responsible person has been convicted of—
an offence outside New Zealand that, if committed in New Zealand, would fall within paragraph (a) or regulation 29(c)﻿(ii).
If the Director-General decides to decline an application, the Director-General must notify the applicant of the decision and the reasons for the decision.
The Director-General must not approve the following to be specified in a licence for a supply activity unless, after assessing the evidence in the application, the Director-General is satisfied of the matter specified:
for a consignment of starting material for export, that a representative sample of the consignment complied with the minimum quality standard; or
for a cannabis-based ingredient or medicinal cannabis product, that a representative sample of at least 10% of each of 3 batches of the ingredient or product complied with the minimum quality standard.
An applicant whose application is declined under regulation 40 may apply to the Director-General for a review of the decision.
The applicant must apply no later than 14 days after the day on which the notice of decision is given to them.
The Director-General must appoint a person to conduct the review (the reviewer), who may be an employee of the responsible department but must not have had any previous involvement in the case.
considers the decision to decline the licence well founded, the reviewer must recommend that the decision be confirmed:
does not consider the decision to decline the licence well founded, the reviewer must recommend that the decision be cancelled and reconsidered.
After considering the recommendation given by the reviewer, the Director-General must—
confirm the decision, or cancel and reconsider the decision; and
give notice to the applicant of the confirmed or new decision.
A notice under subclause (5) has effect as soon as it is given to the applicant.
In issuing or changing a licence, the Director-General may impose any conditions, in addition to the conditions imposed by these regulations, that the Director-General considers, in the circumstances of the particular case, necessary or desirable to meet the purpose of these regulations.
Any conditions imposed when a licence is changed must relate to the changes.
As soon as practicable after approving an application, the Director-General must issue a licence that states the following:
the types of licensed activity, and the specific activities of each type, that are authorised:
for each type of licensed activity, each location where any cannabis, cannabis-based ingredient, or medicinal cannabis product may be—
if applicable, produced, manufactured, or possessed for manufacture:
for a licence for a cultivation activity, whether cultivation is restricted to approved cultivars under the Misuse of Drugs (Industrial Hemp) Regulations 2006:
for a licence for a supply activity, each consignment of starting material for export, or cannabis-based ingredient or medicinal cannabis product, to which the licence applies:
any conditions imposed by the Director-General.
The stated period must not exceed 1 year.
If an application for renewal of a licence is made no earlier than 90 days, and no later than 30 days, before the expiry of the licence, the licence continues in force until the application for renewal is determined.
These regulations apply to an application for a renewal of a licence as if it were an application for a new licence, except for the fees payable in relation to types of licensed activities.
A licence issued on an application under this regulation—
must be treated as a licence issued under regulation 43; and
starts when the earlier licence expires.
A licence holder may, at any time, surrender the licence to the Director-General, in which case the licence expires on the date on which the licence is received by the Director-General.
A licence holder must not change any of the following matters without the prior approval of the Director-General:
the composition of the board of directors of the body corporate or partners of the partnership:
anything at the locations specified in the licence that affects a location’s security arrangements:
the activities, or types of licensed activity, authorised by the licence:
any responsible person:
for a licence for a supply activity, any of the following matters relating to a consignment of starting material for export, or any cannabis-based ingredient or medicinal cannabis product, specified in the licence:
its trade name:
the label or description that will accompany it:
its composition, or its formulation (meaning its ingredients and the quantity or proportion of each ingredient):
its method of manufacture (including packing and testing):
its container closure system:
the facilities for its manufacture (including packing and testing):
the recommended method of administering, applying, or using it:
its shelf life or storage conditions.
A licence holder cannot change the locations specified in the licence.
An approval under this regulation must be sought by a written application, in a form provided by the Director-General, that—
includes the new information for the matters sought to be changed that would be required in an application for a licence; and
is accompanied by the licence; and
is made at least 60 days before a proposed change is to take effect.
The Director-General must consider whether the application satisfies the requirements of this Part that relate to the matters that are sought to be changed.
If the Director-General approves a change described in any of subclause (1)﻿(c) to (e), the Director-General must amend the licence or issue a replacement licence to reflect the approved change.
Fees are payable if the application is for—
the addition of 1 or more new types of licensed activity to the licence; or
any change relating to a location used for a type of licensed activity, if the Director-General is satisfied that the change affects the location’s security arrangements.
The fees that are payable are—
the fee payable under regulation 34 for the initial check of whether an application appears to be in order:
if the initial check confirms that the application appears to be in order, the fee payable under regulation 34 for the consideration of an application to add each new type of licensed activity to which subclause (6) applies.
Fees are also payable—
under regulation 35 if the applicant makes a declaration under that regulation when applying; or
under regulation 36 if the application relates to a supply activity and—
is an application for a change described in subclause (1)﻿(e), in which case the consignment, ingredient, or product that is being changed must be assessed under regulation 40(5) as if it were not already specified in the licence; or
that regulation otherwise applies.
ceased to be a responsible person as a result of a cancellation of approval under regulation 49.
The licence holder must, as soon as practicable, seek the Director-General’s approval, under regulation 47, for an eligible individual to replace the individual who has ceased to be a responsible person.
The Director-General may cancel the approval of an individual given under regulation 40 if the Director-General is satisfied that the individual—
has ceased to be eligible under regulation 31; or
Before cancelling the approval of an individual, the Director-General must—
give the individual an opportunity to make submissions on the proposal within a reasonable period; and
The Director-General must give notice of a cancellation under this regulation to the individual and to the licence holder.
Whenever there is a change in the place where a licence holder’s records are kept or a change in the address or the contact details of a licence holder or responsible person, the licence holder must, no later than 15 days after the change, give the Director-General notice of the change.
The licence holder must keep their licence in a secure place at all times when the licence is not required to be produced under these regulations.
An activity authorised by a licence may be carried out only in the location or locations specified for the activity in the licence.
An activity authorised under a licence may be carried out only if it is carried out under the control of—
Every licence holder and every responsible person must deal with any cannabis, cannabis-based ingredients, and medicinal cannabis products that are in their possession or control in a way that effectively guards against the risk of misuse for unlawful purposes.
take all reasonable steps to ensure that every employee, agent, and contractor complies with the conditions and provisions.
The expenses incurred in complying with the conditions and provisions must be met by the licence holder.
A licence holder must ensure that all cannabis, cannabis-based ingredients, and medicinal cannabis products are securely protected against access by unauthorised individuals and any animals.
A licence holder must take all reasonable steps to ensure that cultivated cannabis does not spread outside the locations to which the licence applies.
any cannabis, cannabis-based ingredient, or medicinal cannabis product that is in the licence holder’s possession or control is removed without authority or lost; or
there is any unauthorised activity at a place where cannabis is cultivated or stored.
After the licence holder, or any employee or agent of the licence holder, becomes aware of the removal, loss, or activity, the licence holder must report it—
immediately to a member of the Police; and
as soon as practicable, but within 3 days, to the Director-General.
In subclause (2), assistance includes—
co-operating with the authorised person in the inspection of the premises, processes, and materials at the location, and the taking of samples of cannabis, cannabis-based ingredients, or medicinal cannabis products.
An authorised person who carries out an inspection under this regulation must carry identification and other documentation that confirms the person’s authority to inspect, and must show that identification and authorising documentation on request.
In this regulation, authorised person means a person authorised in writing by the Director-General to exercise the powers under this regulation.
The Director-General may, at any time, take samples of the following from a location specified in the licence holder’s licence:
any cannabis:
a medicinal cannabis product:
any label, packaging, or description relating to those things.
The samples may be taken only for the purposes of examining or testing them.
The licence holder must, at their own cost, destroy each of the following that they have and that is not required, or to be supplied, under the licence:
The licence holder must provide evidence of the destruction to the Director-General on request.
If the Director-General believes on reasonable grounds that a current or former licence holder has abandoned any growing or harvested cannabis that is subject to the licence holder’s licence, the Director-General may treat the cannabis as surrendered to the Director-General.
The Director-General may recover from the licence holder any costs incurred in managing or disposing of the cannabis.
The holder of a licence for a cultivation activity must keep records of the amounts of cannabis that the holder, under the licence,—
cultivates; or
maintains for the purposes of propagation; or
produces and stores; or
supplies within New Zealand to the holder of a licence; or
destroys or disposes of.
The holder must also keep records of the following for activities authorised by the licence:
a failure by the holder, in any season, to sow cannabis seeds intended for sowing:
a failure of any cannabis seeds sown by the holder to germinate, or of any crop of cannabis plants to attain maturity, for any reason.
The holder of a licence for a nursery activity must keep records of—
the amounts of cannabis seeds and cannabis plants that the holder supplies under the licence; and
the amounts of cannabis seeds and cannabis plants that the holder possesses under the licence.
The holder of a licence for a research activity must keep records of—
the amounts of each medicinal cannabis product that the holder supplies or administers under the licence; and
the amounts of starting material, cannabis-based ingredients, and medicinal cannabis products that the holder possesses under the licence.
The holder of a licence for a possession for manufacture activity must keep records of the following for activities carried out under the licence:
the amounts of medicinal cannabis products that the holder possesses after manufacturing them:
the amounts of starting material and cannabis-based ingredients that the holder possesses.
The holder of a licence for a supply activity must keep records of—
the amounts of starting material, cannabis-based ingredients, and medicinal cannabis products that the holder supplies under the licence; and
This regulation applies in respect of each of the following (a material) that a person possesses in accordance with a licence at the end of any year (the time of stocktake):
record the actual amount of the material that they possess at the time of stocktake; and
prepare an account that compares the recorded amounts of the material that they possess during the year with the actual amount at the time of stocktake, including an explanation of any differences between the recorded and actual amounts.
The records and account must be completed by 31 January after the time of stocktake.
Every matter that must be recorded must be kept up to date.
The records must be retained for at least 5 years after they are made.
The records may be kept on paper or in electronic form.
The records must be readily accessible, retrievable, and secure from tampering.
Every licence holder must provide to the Director-General a copy of any record as soon as practicable after the Director-General requests a copy.
Regulation 47 of the Misuse of Drugs Regulations 1977 applies to any export or supply under a medicinal cannabis licence—
as if the holder of the medicinal cannabis licence were a person licensed under those regulations to deal in controlled drugs; and
as if that regulation applied to disposal by wholesale or retail; and
The Director-General may, by notice to the licence holder, suspend a licence if satisfied that the licence holder has—
provided any false information in the application for the licence or for a change to the licence; or
breached any condition of the licence or provision of these regulations.
the start date of the suspension (which must not be before the date on which the notice is given to the licence holder):
the end date of the suspension (which must not be more than 30 days after the start date):
the false information that was provided or the breach that has occurred:
the corrective action to be taken to remedy or mitigate the false information or breach:
the Director-General will, unless the suspension is cancelled on review, keep a record of the suspension:
the record will be taken into account in the consideration of any future application that involves the licence holder, any directors or partners of the licence holder, or any individual who is a responsible person for the licence.
The period of suspension ends on the date stated in the notice unless at any time during that period the Director-General, by notice to the licence holder,—
extends that period by a further period of no more than 30 days; or
The Director-General may, under subclause (2)﻿(b), substitute an earlier date only if satisfied that the licence holder has taken the corrective action stated in the notice given under regulation 71 or that the action is not, or no longer, required.
is not authorised to carry out any authorised activity under that licence without the prior written permission of the Director-General; but
may tend growing cannabis and, if necessary, harvest it, if those are authorised activities under the licence.
A permission given under subclause (1)﻿(a) may be subject to any stated restrictions or conditions, or both.
The Director-General may, by notice to the licence holder, revoke the licence of the licence holder if satisfied that—
the licence holder has, within any period during which the licence holder’s licence was suspended, failed to take the corrective action stated in the notice given under regulation 71; or
the licence holder or any director or partner of the licence holder has been convicted of an offence against the Misuse of Drugs Act 1975 or any other drug-related offence; or
the licence holder has knowingly provided any false information in the application for the licence or for a change to the licence; or
the date on which the revocation takes effect (which must not be before the 14th day after the date on which the notice is given to the licence holder):
the right of the licence holder to apply for a review of the revocation.
the Director-General will, unless the revocation is cancelled on review, keep a record of the revocation:
For the purposes of these regulations, the revocation of a licence takes effect on the date stated under regulation 74(2)﻿(a) unless the licence holder concerned applies for a review in accordance with regulation 76, in which case it takes effect if and when notice is given, under regulation 76(5), that the decision to revoke has been confirmed.
A licence holder whose licence has been suspended under regulation 71 or revoked under regulation 74 may apply to the Director-General for a review of the suspension or revocation.
The licence holder must apply no later than 14 days after the day on which the notice of suspension or revocation is given to them.
In the period starting on the day on which an application for review of the revocation of a licence is lodged and ending at the end of the day on which the application is withdrawn or determined, the applicant—
is not authorised to carry out any authorised activity under that licence; but
A person commits an offence if they knowingly provide any false information in an application for a licence or for a change to a licence.
A person commits an offence if, acting or purporting to act under a medicinal cannabis licence, they—
supply any cannabis, cannabis-based ingredient, or medicinal cannabis product within New Zealand to a person who is not authorised to procure or receive it under any of the following:
a licence issued under the Misuse of Drugs Act 1975 or any other regulations made under that Act; or
export any cannabis, cannabis-based ingredient, or medicinal cannabis product from New Zealand to a person in an overseas country who is not authorised, under the law of that country, to procure it.
A person commits an offence if, being the licence holder of a licence or a responsible person, they breach a condition of the licence imposed by or under these regulations.
A person who commits an offence against these regulations is liable to a fine not exceeding $500, and, if the offence is a continuing one, to a further fine not exceeding $20 for every day or part of a day during which the offence has continued.
A notice that is required to be given to a person under these regulations must be in writing and be given to the person in 1 of the following ways:
A requirement under these regulations to give a notice to a licence holder who is a body corporate or a partnership is satisfied if the notice is given, in accordance with subclause (1), to an individual who is a responsible person for the licence.
Part 3 Amendments to other regulations
Regulations 84 and 85 amend the Medicines Regulations 1984.
The minimum quality standard imposed by Part 1 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 applies to a CBD product as if it were both a cannabis-based ingredient and a medicinal cannabis product under those regulations.
However, the minimum quality standard does not apply to a CBD product that is imported by—
a medical practitioner whose purpose is to prescribe, supply, or administer it for the treatment of a particular patient under their care; or
a pharmacist for a prescription to which paragraph (a) applies.
Subclause (4) applies to a CBD product of a type that, at the commencement of this regulation, has been imported into New Zealand by the holder of a licence issued under the Medicines Act 1981.
The minimum quality standard does not apply to any of that product of the licence holder during the 6-month period that starts at the commencement of this regulation.
In this regulation, CBD product has the meaning given by section 2A of the Misuse of Drugs Act 1975.
After regulation 45A, insert:
A licence to manufacture medicines, to sell medicines by wholesale, to pack medicines, or to operate a pharmacy that is issued under these regulations does not apply to a CBD product (as defined by section 2A of the Misuse of Drugs Act 1975) unless expressly authorised by the licence.
The licence must not be issued, or amended, to expressly authorise its application to a CBD product unless the product has been assessed as complying with the minimum quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019.
A product is assessed as complying with the minimum quality standard under those regulations if—
an application is made under those regulations to assess the CBD product, in which case those regulations (including the requirement to pay fees) apply for that purpose as if the product were being assessed as a medicinal cannabis product; and
the Director-General assesses the evidence in the application and is satisfied that a representative sample of at least 10% of each of 3 batches of the product complied with the minimum quality standard.
Regulations 87 to 89 amend the Misuse of Drugs Regulations 1977.
After regulation 3B, insert:
A licence to cultivate a prohibited plant, or to possess controlled drugs, must not be issued under these regulations in respect of any of the following, as defined by the Misuse of Drugs (Medicinal Cannabis) Regulations 2019:
any starting material:
After regulation 7(8), insert:
A licence to import, or a licence to export, controlled drugs must not be granted in respect of any starting material, cannabis-based ingredient, or medicinal cannabis product (all as defined by the Misuse of Drugs (Medicinal Cannabis) Regulations 2019) unless—
the applicant holds a medicinal cannabis licence (as defined by those regulations); or
the applicant is a medical practitioner whose purpose is to import the controlled drugs to prescribe, supply, or administer them for the treatment of particular patients under their care, and the Minister gives written approval to the grant of the licence; or
the applicant is a pharmacist whose purpose is to import the controlled drugs for a prescription to which paragraph (b) applies.
After regulation 22(2)﻿(b), insert:
any of the following that have been assessed as complying with the minimum quality standard, and specified in a medicinal cannabis licence accordingly, under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019:
Regulation 91 amends the Misuse of Drugs (Industrial Hemp) Regulations 2006.
This regulation applies to a licence holder of 1 or more licences (whether a general or a research and breeding licence) that authorise the supply within New Zealand of industrial hemp.
The licence holder is also authorised to supply, within New Zealand, no more than 50 seeds and 20 plants of industrial hemp to each holder of a medicinal cannabis licence for a cultivation activity under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019.
However, a licence issued under these regulations does not authorise the licence holder to carry out any activity for which a medicinal cannabis licence is required under those regulations.
1 Existing licences to import controlled drugs
This clause applies to a medicinal cannabis product of a type—
that, at the commencement of these regulations, has been imported into New Zealand by the holder of a licence to import controlled drugs issued under the Misuse of Drugs Regulations 1977; and
for which that licence holder has applied for a medicinal cannabis licence for a supply activity no later than 30 days after the commencement of these regulations.
The minimum quality standard does not apply to any of that product of the licence holder during the 6-month period that starts at the commencement of these regulations.
2 Existing licences to possess controlled drugs
This clause applies to a person who, at the commencement of these regulations, holds a licence to possess controlled drugs that is issued under the Misuse of Drugs Regulations 1977 and authorises any activity for which a medicinal cannabis licence is required under these regulations.
The person may continue to act in accordance with the licence only until the later of the following:
the date that is 30 days after the commencement of these regulations:
the time when an application for a medicinal cannabis licence that was made within those 30 days is determined.
3 Existing licences to cultivate for scientific or research purposes
This clause applies to the holder of a licence to cultivate a prohibited plant, for scientific or research purposes, that was issued under the Misuse of Drugs Regulations 1977 and held at the commencement of these regulations.
If the licence holder also becomes the holder of a medicinal cannabis licence for a cultivation activity, they may retain all cannabis seeds and no more than 50 cannabis plants for the purposes of the medicinal cannabis licence, despite any condition in the licence to cultivate a prohibited plant.
impose a minimum quality standard for medicinal cannabis products and related material and ingredients (Part 1); and
provide for medicinal cannabis licences that authorise various activities relating to medicinal cannabis products and related material and ingredients (Part 2).
The regulations come into force on 1 April 2020.
Part 1—Minimum quality standard relating to medicinal cannabis products
Regulation 7 sets out maximum limits that certain things must not exceed when medicinal cannabis products, or related material or ingredients, are tested in accordance with the European Pharmacopoeia.
Regulation 8 sets out other requirements that medicinal cannabis products, or related material or ingredients, must comply with. The requirements are detailed in regulations 10 to 21.
Part 2—Medicinal cannabis licences
A medicinal cannabis licence authorises the licence holder to carry out 1 or more of the following:
But licences under other enactments may also be needed.
There are provisions about—
eligibility for licences (regulations 29 to 31):
making and assessing applications for licences (regulations 32 to 39):
issuing, renewing, and changing licences (regulations 40 to 51):
terms and conditions relating to activities authorised by licences (regulations 52 to 61):
record-keeping and reporting under licences (regulations 62 to 70):
suspending and cancelling licences (regulations 71 to 77):
offences relating to licences (regulations 78 to 81):
giving notices (regulation 82).
Part 3—Amendments to other regulations
Part 3 makes related amendments to other regulations.
The Ministry of Health produced a regulatory impact assessment on 1 October 2019 to help inform the decisions taken by the Government relating to the contents of this instrument.
https://www.health.govt.nz/about-ministry/information-releases/regulatory-impact-statements