Cannabidoil, also known as CBD, is one of over 60+ naturally occurring cannabinoid compounds found in the cannabis plant. Cannabidiol (CBD) is a substance found in cannabis that has potential therapeutic value and little-to-no psychoactive properties. CBD products are prescription-only medicines. This page contains information on medicinal cannabis products that meet the medicinal cannabis minimum quality standard.
Cannabidoil, also known as CBD, is one of over 60+ naturally occurring cannabinoid compounds found in the cannabis plant and is derived from an organic substance formed in the plant’s secretion. It is the top non-psychoactive compound found in cannabis and does not cause any feeling of “high”. CBD is being scientifically investigated for numerous medicinal and therapeutic applications.
How does CBD work?
CBD largely interacts with your body’s own endocannabinoid system, made up of millions of cannabinoid receptors found mainly in the brain and nervous systems, but also throughout your whole body. The endocannabinoid system has four main functions including stress relief, neuroprotection, immune response and regulating the body’s overall state of balance which involve things like digestion, reproduction, appetite and pain.
The passing of the Misuse of Drugs (Medicinal Cannabis) Amendment Act means some products containing cannabidiol (CBD) are now prescription medicines only.
CBD is a substance found in cannabis that has potential therapeutic value, with little or no psychoactive properties.
Cannabidiol (CBD) is no longer a class B1 controlled drug under the Misuse of Drugs Act 1975. It is a prescription medicine under the Medicines Act 1981.
As with all prescription medicines, patients must have a prescription from an authorised prescriber to import or use CBD products. If you are interested in using CBD for a medical purpose, please talk to your doctor.
CBD is no longer a controlled drug. In addition, to increase access to CBD products, while minimising risks, a small amount of tetrahydrocannabinols and other psychoactive related substances are now permitted as contaminants in CBD products. In CBD products, the amount of tetrahydrocannabinols and psychoactive related substances must not exceed 2 percent of the total CBD tetrahydrocannabinol and psychoactive related substances content in the product.
This change to the control of CBD products is in response to advice the Government received from the Expert Advisory Committee on Drugs. It is important to note that medicinal cannabis products such as Sativex are not CBD products (refer Prescribing cannabis-based products).
Further information on prescribing medicinal cannabis and CBD products can be found on Prescribing cannabis-based products.
Bringing CBD products into New Zealand
No individual may leave or enter New Zealand with illicit cannabis, even if they have been diagnosed by a medical or nurse practitioner as requiring palliation. You can travel with 1 months’ supply of controlled drugs (eg, Sativex) or 3 months’ supply of prescription medicines (eg CBD products) provided you are able to show they have been lawfully supplied to you.
For further information on bringing medicines containing controlled drugs (eg Sativex) into New Zealand read Bringing medicines into New Zealand.
Importing of CBD Products into New Zealand by Patients, Pharmacies, Medical Practitioners and Wholesalers
Patients may import up to three months’ supply of a CBD product into New Zealand if they have a reasonable excuse, that is, an original letter or an original prescription from a New Zealand authorised prescriber. An import licence is not required but please note that the points 1, 2 and 3 listed below also apply to imports by patients.
For further information on bringing medicines (eg CBD products) into New Zealand, refer to Medsafe’s website:
Pharmacies, authorised prescribers and licensed wholesalers of medicines are able to import CBD products, and are not required to have an import licence under the Misuse of Drugs Act.
- some overseas countries require an licence to export CBD products eg Australia and Canada,
- some countries prohibit the export of CBD products eg the United States,
- many products listed on websites as CBD products do not meet the New Zealand definition as the THC content is too high. These products are controlled drugs and cannot be legally imported into New Zealand without a licence to import a controlled drug issued by Medicines Control at the Ministry of Health and a licence to export from the exporting country,
- CBD products are all non-consented medicines and can only be imported by authorised prescribers for a particular patient under their care or by pharmacists pursuant to a prescription for a particular patient,
- non-consented medicines cannot be advertised,
- wholesalers and pharmacists must complete reporting requirements to Medsafe as required by section 29 of the Medicines Act 1981.
There is a limited range of CBD products available
While the intent is to make it easier to access CBD products, there is currently a limited range of CBD products available in New Zealand. None of the products currently available have consent for distribution in New Zealand. Strict export restrictions on products sourced from some other countries will continue to impact the supply of CBD products in New Zealand. The range of products available in New Zealand is expected to increase once domestic cultivation and manufacture of medicinal cannabis products is enabled and established.
Medicinal Cannabis Agency – Cannabidiol (CBD) products
Cannabidiol (CBD) is a substance found in cannabis that has potential therapeutic value and little-to-no psychoactive properties. CBD products are prescription-only medicines.
Definition of a CBD product
To be considered a ‘CBD product’ under Section 2A of the Misuse of Drugs Act 1975, the tetrahydrocannabinols (THCs) and specified substances within the product must not exceed 2 percent of the total CBD, tetrahydrocannabinol (THC) and other specified substances.
A Certificate of Analysis from the supplier is required to determine the quantities of CBD and specified substances. If a product contains CBD but does not meet the definition of a CBD product, it is a ‘controlled drug’ and is subject to the regulatory requirements of the Misuse of Drugs Act.
The following examples may assist to determine whether your product meets the definition of a CBD product:
|Category of product||Total amount of CBD||Total amount of THC and specified substances||Percent specified substances|
|CBD product||49 mg||0.7 mg||(0.7) ÷ (49+0.7) x 100 = 1.4%|
|Non-CBD product||5 mg||0.7 mg||(0.7) ÷ (5+0.7) x 100 = 12.3%|
Under Section 2A of the Misuse of Drugs Act 1975, a specified substance is a substance that:
- naturally occurs in cannabis; and
- is —
- a tetrahydrocannabinol; or
- an isomer, ester, or ether of a tetrahydrocannabinol; or
- an ester or ether of an isomer of a tetrahydrocannabinol; or
- a salt of any substance described in (i) to (iii); or
- a substance that has a structure substantially similar to that of any substance described in (i) to (iv); and
The definition of “by any means” includes simple conversion techniques such as heating.
Requirements for a Certificate of Analysis
A Certificate of Analysis can be obtained from the distributor or manufacturer of the CBD product. At a minimum, it should state the:
- details of the laboratory which conducted the analysis
- the laboratory’s ISO accreditation to ISO/IEC 17025:2017
- the date the analysis was carried out
- the name of the product and batch number of the batch analysed
- the amount of CBD, CBDA, Δ9-THC, Δ9-THCA and CBN
- the amount of any other specified substance that is present at detectable levels
- the limits of detection or quantification for all tested substances.
Importing CBD products
If you intend to import and supply CBD products you will need to hold a licence issued under the Medicines Act 1981. This licence must expressly authorise the specific CBD product being imported or supplied. A medicinal cannabis licence is not required.
Before you import a specific CBD product for supply for the first time, you will need to apply to the Medicinal Cannabis Agency for a product assessment to verify it meets the definition of a CBD product and meets the medicinal cannabis minimum quality standard.
You will also need to provide information to establish that the product being imported is the same as the product specified on the Medicines Act licence.
A Certificate of Analysis will typically be sufficient to determine the quantities of CBD and any specified substances, and to establish whether the definition has been met.
A CBD product that has not been verified to have met the minimum quality standard can be imported only by a medical practitioner or pharmacist for a named patient.
Note that many products currently listed on websites as CBD products do not meet the New Zealand definition of a CBD product because the THC content is too high. Therefore, these products are classified as controlled drugs and are treated the same as other medicinal cannabis products.
For further information, please refer to the Ministry of Health guidance on bringing medicines into New Zealand. Further information is also available on the Medsafe webpage.
Personal imports of CBD products
Personal imports of CBD products are not permitted.
A person wishing to import a CBD product for personal use is unlikely to have the information needed to establish that the product meets the minimum quality standard.
If importation of an unverified CBD product is being considered, it should be imported by the prescriber or pharmacy on behalf of the patient.
Domestic manufacture for supply or export
Finished products that meet the definition of a CBD product are not ‘controlled drugs’ under the Misuse of Drugs Act 1975. However, you do need to hold a medicinal cannabis licence with a ‘Possession for manufacture’ activity for the manufacture of a CBD product from cannabis or any cannabis-based ingredient other than pure CBD extract.
Your medicinal cannabis licence does not need to have a ‘Supply’ activity specified in order to supply or export CBD products.
In addition to a medicinal cannabis licence with a ‘Possession for manufacture’ activity to manufacture CBD products, you will need a Licence to Manufacture Medicines issued under the Medicines Act 1981 that expressly authorises the manufacture of a CBD product. This will allow you to manufacture, test, pack and label the CBD product or dosage form.
Before you can supply a CBD product you will need to apply to the Medicinal Cannabis Agency for a product assessment to establish it meets the minimum quality standard.
If your planned activities are limited to re-packing CBD products that have been manufactured by a GMP-compliant facility and verified to meet the minimum quality standard, a Licence to Pack Medicines is required instead of a Licence to Manufacture Medicines. This will allow you to pack and label the CBD product only.
To obtain either licence, you will need to demonstrate compliance with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (the Code of GMP).
Non-cannabis derived CBD products
Synthetic CBD products are unable to be verified to meet the minimum quality standard as they are not derived from the Cannabis plant.
This means that CBD products that have been synthetically manufactured or isolated other than from cannabis (ie, non-cannabis -derived CBD products):
Medicinal cannabis products that meet the minimum quality standard
13 September 2022: New medicinal cannabis products have been verified as meeting the minimum quality standard – Read more.
Generally, medicinal cannabis products are only available, on prescription, if they have:
- been assessed by the Medicinal Cannabis Agency as meeting the minimum quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019, or
- obtained consent for distribution under the Medicines Act 1981 (approved and provisionally approved medicines)
Any doctor can prescribe a product listed here. A specialist recommendation and Ministerial approval are not required. For more information on a particular product, please contact the listed product supplier or manufacturer.
Medicinal cannabis products that meet the minimum quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019
The minimum quality standard is used to verify medicinal cannabis products which have been derived from the Cannabis plant. Synthetic CBD and THC products are unable to be verified to meet the minimum quality standard as they are not derived from the Cannabis plant.
Products that are listed as having been verified as meeting the minimum quality standards are unapproved medicines – there has been no assessment of their safety or efficacy. Being listed here does not guarantee that these products are currently available in New Zealand. Contact the licence holder to obtain the most up-to-date information on product availability.
Dosage Products – Prescription Medicine
The products listed in the following tables are categorised by their verified dosage form. The products have been verified as meeting the testing requirements and microbiological contamination limits applicable to the dosage form as listed.