a cannabis-based ingredient:

a medicinal cannabis product, whether a dried product or dosage product.

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—

it is imported and used by a pharmacist for a prescription to which paragraph (c) applies; or

it is imported and used 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 and used for testing, analysis, or research for non-therapeutic purposes; or

it is for export and is manufactured in compliance with GMP by a GMP-certified manufacturer.

which of the following items, or categories of those items, must be tested:

what the items, or categories of items, must be tested for; and

the chapter(s) of the British Pharmacopoeia, European Pharmacopoeia, or United States Pharmacopeia that set out the testing method(s) that must be used; and

the maximum limit that the test result must not exceed; and

whether the testing method must be validated under regulation 9(2).

heavy metals:

pesticides:

absence of aflatoxins:

ochratoxin A:

foreign matter (for dried cannabis as cannabis-based ingredient):

loss on drying (for dried cannabis as cannabis-based ingredient):

total ash (for dried cannabis as cannabis-based ingredient):

residual solvents.

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).

in the case of a critical test, by a GMP-certified manufacturer or laboratory:

in any other case, by—

for a critical test, by a GMP-certified manufacturer or laboratory; or

in any other case, by a GMP-certified manufacturer or laboratory, or an ISO/IEC 17025:2017 accredited laboratory.

microbiological contamination:

loss on drying:

assay limits for active ingredients:

form and dosage form.

shelf life; and

recommended storage conditions.

any dried cannabis intended to be used as a cannabis-based ingredient before further processing:

any other dried product.

a cannabis-based ingredient:

a medicinal cannabis product (including a dried product).

no less than 80% of its stated content; and

no more than 120% of its stated content.

no less than 90% of its stated content; and

no more than 110% of its stated content.

no less than the lowest quantity specified by the manufacturer of each active ingredient; and

no more than the highest quantity specified by the manufacturer of each active ingredient.

a cannabis-based ingredient:

a medicinal cannabis product.

an active ingredient:

a cannabinoid.

a cannabis-based ingredient:

an ingredient of a medicinal cannabis product.

cannabis from which a cannabis-based ingredient is extracted:

an ingredient of a medicinal cannabis product:

a dried cannabis product.

agricultural chemicals listed or described in Schedule 2 of the Food Notice: Maximum Residue Levels for Agricultural Compounds issued under section 405 of the Food Act 2014 for the purposes of section 383(8)(a) of that Act, and used in accordance with the Food Regulations 2015 and in accordance with use conditions:

products that are registered under the Agricultural Compounds and Veterinary Medicines Act 1997 with a label claim for use on a food crop if—

for imported cannabis-based ingredients or medicinal cannabis products, pesticide active ingredients in products that are registered under the Agricultural Compounds and Veterinary Medicines Act 1997 may be used if—

evidence is provided to the Director-General that demonstrates that the pesticide product has been registered by the relevant overseas authority for use on medicinal cannabis; and

the product has been used in accordance with use conditions; and

a suitable safety assessment has been completed by the relevant overseas authority.

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 controlled drug classification statement takes precedence over a classification statement required under the Medicines Regulations 1984:

if a medicinal cannabis product is a controlled drug, compliance with regulation 25(1)(a) of the Misuse of Drugs Regulations 1977 is required rather than compliance with regulation 13(1)(f) of the Medicines Regulations 1984.

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.

is derived from an animal; and

is contaminated with any transmissible spongiform encephalopathy.

a cultivation activity:

a seed supply activity:

a research activity:

a possession for manufacture activity:

a supply activity.

is specified in the licence; and

is done for a purpose relating to—

to cultivate cannabis:

to procure the following within New Zealand:

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 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, seed supply, research, possession for manufacture, or supply activity:

to export starting material, produced under paragraph (d) as fresh or dried cannabis, for testing, analysis, or research for non-therapeutic purposes under a licence to export controlled drugs issued under the Misuse of Drugs Regulations 1977, limited to the quantities specified in the medicinal cannabis licence:

to export cannabis seed, cuttings, rootstock, tissue, and tissue culture, for the purpose of propagation, under a licence to export controlled drugs issued under the Misuse of Drugs Regulations 1977:

to possess cannabis for the purposes of carrying out any of the activities described in paragraphs (a) to (g).

is specified in the licence; and

is done for a purpose relating to the supply of cannabis seed for cultivation for therapeutic use.

to procure cannabis seed—

to supply cannabis seed within New Zealand to a person who is authorised to receive it by any enactment or a medicinal cannabis licence for a cultivation activity:

to export cannabis seed under a licence to export controlled drugs issued under the Misuse of Drugs Regulations 1977:

to possess cannabis seed for the purposes of carrying out any of the activities described in paragraphs (a) to (c).

is specified in the licence; and

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 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 for the purposes of carrying out any of the activities described in paragraphs (a) and (c).

is specified in the licence; and

is done for a purpose relating to testing, production, or manufacture of cannabis for therapeutic use.

to procure any starting material, cannabis-based ingredient, or medicinal cannabis product—

any of the following manufacturing activities, but only to develop or test the related processes or products or to validate that testing:

to manufacture initial extracts for use as starting material:

to possess any starting material, cannabis-based ingredient, or medicinal cannabis product for the purposes of carrying out any of the activities described in paragraphs (a) to (c).

is specified in the licence; and

is done for a purpose relating to the supply of—

to procure any starting material, cannabis-based ingredient, or medicinal cannabis product—

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 one of the following:

to supply any starting material by export from New Zealand under a licence to export controlled drugs issued under the Misuse of Drugs Regulations 1977:

to supply any cannabis-based ingredient or medicinal cannabis product that has been verified to meet the minimum quality standard by export from New Zealand under a licence to export controlled drugs issued under the Misuse of Drugs Regulations 1977:

to supply cannabis-based ingredients and medicinal cannabis products that have not been tested to the requirements of the minimum quality standard, by export from New Zealand under a licence to export controlled drugs issued under the Misuse of Drugs Regulations 1977, if the items have been manufactured in compliance with GMP by a GMP-certified manufacturer:

to supply cannabis-based ingredients and medicinal cannabis products that have not been tested to the requirements of the minimum quality standard, for testing, analysis, or research for non-therapeutic purposes, by export from New Zealand under a licence to export controlled drugs issued under the Misuse of Drugs Regulations 1977, limited to the quantities specified on the medicinal cannabis licence:

to possess any starting material, cannabis-based ingredient, or medicinal cannabis product for the purposes of carrying out any of the activities described in paragraphs (a) to (f).

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.

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.

has completed an application for the licence; and

is 18 years or older; and

satisfies both of the following, or does not satisfy both of the following but is approved by the Minister:

resides in New Zealand; 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.

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:

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,—

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

is 18 years or older; and

satisfies both of the following, or does not satisfy both of the following but is approved by the Minister:

resides in New Zealand.

the name, address, and contact details of the applicant:

in the case of a body corporate or partnership,—

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 following information about the location or locations to be used for the activity:

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 or similar procedures for the activity, including for—

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:

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,—

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,—

will better match the fees paid with the costs of the services for which they are paid; or

is in the public interest.

is applying for a cultivation activity in relation to a medicinal cannabis licence; or

holds a medicinal cannabis licence for a cultivation activity.

a cannabis-based ingredient:

a medicinal cannabis product, whether a dried product or dosage product.

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.

is satisfied that the applicant is eligible, under these regulations, to hold the licence sought; and

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.

a crime involving dishonesty within the meaning of the Crimes Act 1961; or

an offence outside New Zealand that, if committed in New Zealand, would fall within paragraph (a) or regulation 29(c)(ii).

has assessed the evidence in the application, of which—

is satisfied that each of the 3 representative samples complies with the minimum quality standard.

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.

confirm the decision, or cancel and reconsider the decision; and

give notice to the applicant of the confirmed or new decision.

the name of the licence holder:

if the licence is issued to a body corporate or a partnership, the name of every responsible person:

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—

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 cannabis-based ingredient or medicinal cannabis product to which the licence applies, including whether the ingredients or products are for export only:

the period for which the licence is in force:

any conditions imposed by the Director-General.

must be treated as a licence issued under regulation 43; and

starts when the earlier licence expires.

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 any cannabis-based ingredient or medicinal cannabis product, specified in the licence:

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 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 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.

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—

died, become incapacitated, or for any other reason has become unable to hold the position of responsible person; or

ceased to be a responsible person as a result of a cancellation of approval under regulation 49.

has ceased to be eligible under regulation 31; or

has breached a provision of these regulations or a condition of the licence.

notify the individual of the proposal to cancel the approval; and

give the individual an opportunity to make submissions on the proposal within a reasonable period; and

take into account any submissions received within that period.

the licence holder, if the licence holder is an individual; or

a responsible person, if the licence holder is a body corporate or a partnership.

comply with all conditions imposed on the licence holder by or under these regulations and with all other provisions of these regulations; and

take all reasonable steps to ensure that every employee, agent, and contractor complies with the conditions and provisions.

the licence of a licence holder is removed without authority or lost; or

any cannabis, starting material, 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.

immediately to a member of the Police; and

as soon as practicable, but within 3 days, to the Director-General.

giving the authorised person records kept under these regulations; and

copying those records or permitting the authorised person to remove those records for copying; and

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, starting material, cannabis-based ingredients, or medicinal cannabis products.

any cannabis:

any starting material:

a cannabis-based ingredient:

a medicinal cannabis product:

any label, packaging, or description relating to those things.

any cannabis:

any starting material:

a cannabis-based ingredient:

a medicinal cannabis product.

cultivates; or

maintains for the purposes of propagation; or

produces and stores; or

supplies within New Zealand to—

destroys or disposes of.

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 amounts of cannabis seed that the holder supplies under the licence; and

the amounts of cannabis seed that the holder possesses under the licence; and

the amounts of cannabis seed that the holder destroys or disposes 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; and

the amounts of starting material, cannabis-based ingredients, and medicinal cannabis products that the holder destroys or disposes of.

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 amounts of starting material and cannabis-based ingredients and medicinal cannabis products that the holder destroys or disposes of.

the amounts of starting material, cannabis-based ingredients, and medicinal cannabis products that the holder supplies under the licence; and

the amounts of starting material, cannabis-based ingredients, and medicinal cannabis products that the holder possesses under the licence; and

the amounts of starting material, cannabis-based ingredients, and medicinal cannabis products that the holder destroys or disposes of.

any cannabis:

any starting material:

a cannabis-based ingredient:

a medicinal cannabis product.

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.

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

with any other necessary modifications.

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 right of the licence holder to apply for a review of the suspension.

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.

extends that period by a further period of no more than 30 days; or

substitutes an earlier end date for the period.

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.

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 licence holder has deliberately breached a condition of the licence imposed by or under these regulations.

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 reasons for the revocation:

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:

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.

considers the decision to suspend or revoke the licence well founded, the reviewer must recommend that the decision be confirmed:

does not consider the decision to suspend or revoke the licence well founded, the reviewer must recommend that the decision be cancelled.

is not authorised to carry out any authorised activity under that licence; but

may tend growing cannabis and, if necessary, harvest it, if those are authorised activities under the licence.

to determine the eligibility of an applicant for a licence; and

to take into account the suitability of a person as a licence holder or as a responsible person.

supply any cannabis, starting material, 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:

export any cannabis, starting material, 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.

by giving it to the person:

by leaving it at the person’s place of residence or place of business:

by sending it to the person by email.