Guidelines for New Zealand's commercial medicinal cannabis licenses released

Updated: Apr 1, 2020

Draft regulatory guidelines have been released today, shining a spotlight on the country's new medicinal cannabis licensing requirements. Local cannabis business will begin the process of applying for new commercial licenses from 1 April 2020.



In December 2017, the Government committed to establishing a Medicinal Cannabis Scheme to improve access to quality medicinal cannabis products through:


  • Establishing a licensing regime to enable the commercial cultivation of medicinal cannabis and the manufacture and supply of medicinal cannabis products in New Zealand; and

  • Setting quality standards for medicinal cannabis products to give prescribers, consumers and export markets confidence that the medicinal cannabis products available meet minimum standards of quality.


The Medicinal Cannabis Agency has now been established within the Ministry of Health to administer the Scheme. The Misuse of Drugs (Medicinal Cannabis) Regulations 2019 sets out the minimum quality standard that applies to medicinal cannabis products. It also sets out the licensing framework for activities relating to the cultivation of medicinal cannabis and the manufacture and supply of medicinal cannabis products.


A draft guidance document was released today, provided to assist local businesses in applying for a medicinal cannabis licence in New Zealand.


Licensing framework


The Scheme introduces a single medicinal cannabis license approach. This means that a company's licence will specify activities that can be undertaken. Additional activities can be added as needed, by applying to the agency (MOH) and paying additional licence fees.


There are five activity types allowed under the single medicinal cannabis licence:


  1. cultivation activity

  2. nursery activity

  3. research activity

  4. possession for manufacture activity

  5. supply activity


Businesses (or individuals) must apply for a medicinal cannabis licence and at least one of the above mentioned activities. Applicants can choose whichever activity or combination of activities for which they wish to be licensed. The licensing framework enables businesses to submit a single application to conduct multiple activities, with the intention of reducing the overall administrative burden of the process.


One of the medicinal cannabis licenses held by Helius Therapeutics

Duration of license


The medicinal cannabis licence is valid for one year from the date of issue and may be renewed on application. The activities authorised under the medicinal cannabis licence will be valid for the period of the licence. This means that an activity that is added to the licence at the time the licence is issued is also valid for one year.


Businesses can apply for activities to be added to their medicinal cannabis licence at any time during the 12-month licence period, but the activities will only be authorised for the duration of the licence period, unless renewed.


Making an application for a medicinal cannabis license


Eligibility for individuals to hold a licence


Firstly, to apply for a medicinal cannabis licence, the form requires you to supply the following information:


  • Applicant details (individual or an entity (body corporate or partnership))

  • Types of activities you wish to be covered by the application for a licence


So, you can apply for a medicinal cannabis licence as an individual or an entity, such as a body corporate or partnership.


To hold a licence, you must be 18 years or older and live in New Zealand.


Ministerial approval is required to issue a licence if you have had:


  • a conviction under the Misuse of Drugs Act 1975; or

  • a licence issued under the Misuse of Drugs Act 1975 or any regulations made under that Act that has been revoked.


In deciding whether to approve an application, the Director-General may also have regard to whether you have been convicted of a crime involving dishonesty in New Zealand or overseas, or an offence overseas that, if committed in New Zealand, would be an offence under the Misuse of Drugs Act 1975.


To clarify this further, a crime involving dishonesty is described in the Crimes Act 1961. It generally includes theft, fraud, receiving, conversion, corruption, bribery, trading in influence and corrupt use of information. Offences against the Misuse of Drugs Act 1976 include the manufacture, supply or possession of illicit substances, including the possession of utensils. Convictions covered under the Criminal Records (Clean Slate) Act 2004 may not need to be disclosed. Click here for more information about this.


You must be entitled to use the location/s specified in the application for the licence, for the types of licensed activity sought. If you don’t own the property, you must obtain written permission from the owner to use the property for the licensed activity sought and submit this with your application.


You must also be familiar with, and have the expertise and resources to comply with, the obligations imposed on the licence holder under these regulations, for the types of licensed activity sought.


Eligibility for businesses (entities) to hold a licence


A body corporate must be incorporated in New Zealand or the partners of the entity must reside in New Zealand.


Directors or partners of an entity are subject to the same requirements as individuals, mentioned above. They must be 18 years or older, must have permission to use the location/s where activities will be undertaken, and ministerial approval will be required to issue a licence if the entity or any director or partner of the entity has a conviction under MoDA or has had a previous license revoked.


One or more directors or partners of the entity must have the expertise, and the entity the resources to comply with the obligations imposed on the licence holder by the regulations for the types of licensed activity sought.


Eligibility to be a responsible person


Licenses require someone to be the nominated responsible person. This individual must be 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. Again, a responsible person must meet the background criteria.



Criminal conviction history will be requested


The regulations require the Medicinal Cannabis Agency to check with the Ministry of Justice as to whether an applicant, director, partner or nominated responsible person has a conviction for a relevant crime or offence.


To enable the Agency to do this, each applicant individual, director, partner or nominated responsible person must fill in the Ministry of Justice Request criminal convictions history form, which can be found here. Suitable identification must be submitted with the form.


Activities covered by the medicinal cannabis licence


At least one activity must be included in an application for a medicinal cannabis licence. Further activities can be added once the licence has been issued but will only be covered by the licence for the remainder of the duration of the licence.

The medicinal cannabis licence can cover:


  • one activity at one site only; or

  • one or more activities at the same site; or

  • one or more activities at different sites.


Consideration of your application involves an assessment of the activity and an assessment of the site, including verification security arrangements. A separate application is required for each activity and/or for each site.


Enwave cannabis drying technology, used at the Helius site in Auckland

Application fees


Fees will be payable for a medicinal cannabis license. The following table sets out the costs which are exclusive of GST.



The initial check is to confirm that an application appears to be in order. Incomplete applications will be returned and you will be advised that a new application will be required. The fee for the initial check must be paid when the application is submitted. If the initial check verifies that the application appears to be in order then you will be invoiced and must pay the full application fee before your application can be considered.


During the assessment of your application, the Medicinal Cannabis Agency may need additional information and clarification. If further information is requested, a licence cannot be granted until that information has been provided and the Agency is satisfied that all concerns have been addressed.


The application fee is calculated on the cost of the medicinal cannabis licence plus the cost for each activity. For example, if someone applies for a new licence for a cultivation and supply activity, they must first 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:


  1. $2,250 for consideration of the new licence; and

  2. $10,300 for consideration of the 2 new types of licensed activity ($4,750 for the cultivation activity + $5,550 for the supply activity).

If the application is for supply of a new dosage product, the applicant must also pay a further $13,400 under the regulations. All amounts are plus GST.


Once you have submitted an application form and paid the required fee, the application cannot be altered. The application fee is non-refundable.


Cannabis activities that can be undertaken


Certain activities can be added to a medicinal cannabis licence. These are as follows:


Cannabis under cultivation at Helius in East Tamaki

1. Cultivation activity


This activity covers:

  • Cultivation of cannabis for therapeutic use, including growing, harvesting and drying cannabis plant material.

  • Procurement of cannabis: - from a 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 its supply. - no more than 50 seeds and 20 plants (from any source) of a variety of cannabis that is established in New Zealand and that the applicant has declared (under reg 35). - import under a MoDA licence to import controlled drugs.

  • Production of starting material, including by harvesting or drying cannabis.

  • Supply within New Zealand to a person who is authorised to receive it.

  • Possession of cannabis.


Cannabis seedlings in a chamber, located within Helius' R&D nursery

2. Nursery activity


This activity covers:

  • Supply of cannabis seeds or plants for cultivation of cannabis for therapeutic use.

  • Procurement of cannabis from a holder of a medicinal cannabis licence that authorises its supply.

  • Import under a MoDA licence to import controlled drugs.

  • Supply within New Zealand to a person who is authorised to receive it.

  • Possession of cannabis.


Testing for research activity inside the Helius R&D laboratory

3. Research activity


This activity covers:

  • Research about cannabis for therapeutic use.

  • Procurement of cannabis for research purposes from a holder of a medicinal cannabis licence that authorises its supply.

  • Import under a MoDA licence to import controlled drugs for research purposes.

  • Produce or manufacture a cannabis-based ingredient or medicinal cannabis product for research purposes.

  • Supply or administer a medicinal cannabis product for research purposes.

  • Possession of any starting material, cannabis-based ingredient, or medicinal cannabis product for research purposes.


Controlled substances (THC) being tested in the Helius analytical lab, prior to manufacturing activity

4. Possession for manufacture activity


A licence to manufacture medicines, issued under the Medicines Act 1981, is also required to manufacture products for patient use


This activity covers:

  • Procurement of any starting material, cannabis-based ingredient, or medicinal cannabis product from a holder of a medicinal cannabis licence that authorises its supply by import under a MoDA licence to import controlled drugs.

  • 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.

  • Possession of any starting material, cannabis-based ingredient, or medicinal cannabis product.


Dried cannabis flower as starting material

5. Supply activity


This activity covers:

  • Procurement of any starting material, cannabis-based ingredient, or medicinal cannabis product from a holder of a medicinal cannabis licence that authorises its supply; or by import under a MoDA licence to import controlled drugs.

  • Supply of starting material not intended for export, cannabis based ingredient, or medicinal cannabis product within New Zealand to a person authorised to receive it Supply by export of starting material intended for export, cannabis-based ingredient, or medicinal cannabis product that is specified on a licence to export controlled drugs issued under the Misuse of Drugs Regulations 1977.

  • Possession of any starting material, cannabis-based ingredient, or medicinal cannabis product


The following information is required for each type of licensed activity to be added to the medicinal cannabis licence.