Regulations providing for commercial medicinal cannabis cultivation and manufacturing were enacted today, 1 April 2020. The Ministry of Health has also established a Medicinal Cannabis Agency, to administer the scheme.
The Medicinal Cannabis Scheme is now enacted. These regulations have been established to improve access to quality medicinal cannabis products. It will do so through increasing the supply of products by establishing a licensing regime, enabling the cultivating of cannabis in New Zealand and the manufacture and supply of medicinal cannabis products made to quality standards. For the Scheme to meet these objectives, it must deliver quality products to patients and be commercially sustainable.
The Scheme covers cannabis products originating from the cannabis plant for medicinal use. It does not cover medicinal cannabis products manufactured from synthetic cannabinoids or cultivating and manufacturing cannabis products for non-medical use.
There will be a single, overarching medicinal cannabis licence to cover medicinal cannabis activities. This licence will specify activities that can be undertaken. Additional activities can be added as needed, by applying to the Agency and paying the additional licence fees.
At the time of application, companies will apply for a medicinal cannabis licence and specify at least one activity that they wish to undertake. For example, an applicant may apply for a licence including a cultivation activity and possession for manufacture activity.
There are fees associated with the assessment of the licence application and for each activity proposed to be undertake under the licence.
Timings and the impact of COVID-19
The Medicinal Cannabis Agency has been working towards having all medicinal cannabis licence and activity application forms, and all guidance material, available on their website for the commencement date of 1 April 2020.
However, a large number of Ministry of Health staff are either working on the response to the COVID-19 pandemic or working remotely (or both).
"We are doing our best to make the documents available as soon as we can, but the Ministry staff involved are working under extraordinary circumstances. We will let you know as soon as the forms and guidance become available", said a representative from the Medicinal Cannabis Agency.
The COVID-19 lockdown also means the Ministry has to make some adjustments to the way they work, as staff will not be in the office during New Zealand's Alert Level 4 lockdown.
This means that:
The Medicinal Cannabis Agency staff are not able to answer phone calls, so stakeholders should email them via firstname.lastname@example.org.
Agency staff will be monitoring the mailbox remotely; however, as they are already receiving a large number of enquiries, it may take a few days for their team to respond to enquiries.
Staff will be assessing applications during the lockdown period; however, their assessments may take a little longer than the 3-months originally anticipated.
If the COVID-19 lockdown continues for an extended period (which we understand it likely will), the Agency staff won't be able to carry out location inspections. If this is the case, they will be reviewing plans for carrying out location inspections as part of the assessment process.
Benefits for patients
Officials had just 12 months to design and finalise the new medical cannabis regulations, consulting healthcare professionals and the burgeoning industry during that time. Overall, they have done well to deliver on both the public and parliament’s desire for Kiwi patients to have greater access to affordable medicinal cannabis products.
Key to delivering on patient access was the decision to drop the requirement for specialist sign-off on prescriptions which had been proposed in the July discussion document.
This means all GPs will be able to prescribe medicinal cannabis products without additional oversight, and for any condition. Unlike some other countries, there will be no list of ‘qualifying ailments’ they need to abide by.
CBD: Products containing less that 2% THC are now classified as Prescription Medicines and are prescribed just like any other medicine – they can also be prescribed by a nurse practitioner the product is an Approved Medicine.
THC and other cannabinoids: Medicinal cannabis products containing more than 2% THC (or any cannabinoids other than CBD) are now classified as Controlled Drugs B1. These can also be prescribed by any doctor and no longer require ministerial approval. Patients should expect that most doctors will take a more cautious approach to prescribing these products, at least in the short-term.
The scheme will help restore the quality of life to thousands of New Zealanders, delivering access to high quality Kiwi-produced medicinal cannabis products.
Activities under a medicinal cannabis licence
Under a medicinal cannabis licence, the following activities that will be allowed:
Possession for manufacture
We've outlined these activities for you below below. Helius has also prepared a comprehensive guide to cannabis licensing, which can can read here.
You will need to apply for a cultivation activity to be included on your licence if you wish to cultivate cannabis to:
Manufacture a medicinal cannabis product
Export starting material (note: this activity also requires the applicant to apply for a supply activity)
Undertake research involving cultivation, including breeding research
Activities considered to be part of cultivation are:
Possession of plant material and seed for the purposes of the activities
Harvesting (including trimming)
harvesting (including trimming)
Drying of plant material and seed
Supply of plant material to another holder of an appropriate licence (such as a manufacturer or cultivator)
Activities that are not considered to be part of cultivation are:
Further processing of plant material. This includes processing (for example, extraction or grinding) for testing
The supply of cannabis as a medicinal cannabis product.
Companies will need to apply for a research activity they you wish to:
Supply or administer a medicinal cannabis product to a person who is a research subject
Companies like Helius who are conducting clinical trials using medicinal cannabis products that are controlled drugs will require a medicinal cannabis licence with this activity, as well as approval under section 30 of the Medicines Act 1981.
Possession for manufacture activity
You will need to apply for a possession for manufacture activity if you wish to:
Manufacture a cannabis-based ingredient or a medicinal cannabis product
Perform laboratory testing on medicinal cannabis
The possession for manufacture activity allows:
The possession of cannabis for manufacture or testing purposes
The development of medicinal cannabis products and processes related to this
The manufacture of a cannabis-based ingredient or a medicinal cannabis product and processes related to this, including process validation (see note below)
Testing of cannabis and starting material for export, cannabis-based ingredient and medicinal cannabis products and processes related to this
Note: The possession for manufacture activity does not allow the manufacture of a medicine for human consumption. In order to do this, businesses will also require a Licence to Manufacture Medicines, issued under the Medicines Act 1981.
Companies will need to apply for a product supply activity if they wish to supply the following products in New Zealand or overseas:
Starting material for export, cannabis-based ingredient and medicinal cannabis product (dried product and dosage products).
Note: a product supply activity is not required for the distribution of products that meet the definition of a CBD product. You will need to have a licence under the Medicines Act; either a License to Manufacture Medicines, a Licence to Pack Medicines, or a Licence to Sell Medicines by Wholesale.
All products to be 'supplied' must be listed on the licence. For a product to be listed on the licence it must meet the quality standards. Read more about the minimum quality standards.
You will need to apply for a nursery supply activity if you wish to:
Supply cannabis seeds to licensed medicinal cannabis cultivators
To procure the seeds from overseas, a licence to import controlled drugs will be required. If a company or individual wishes to supply cannabis plants, or grow plant from the seed, they will need to have a medicinal cannabis licence with cultivation activity. Seeds can also be supplied if they hold a medicinal cannabis licence with cultivation activity, however this has a higher fee due to allowing a wider range of activities.
For more information on the Medicinal Cannabis Agency, visit the website here.