Helius Therapeutics is a biotechnology company focused on medicinal cannabis research and development in Auckland, New Zealand 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.
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The Ministry of Health maintains a list of Medicinal Cannabis Products verified as meeting their minimum quality standard.
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Helius Therapeutics is a GMP certified biotechnology company focused on medicinal cannabis research and development. We have designed and built a state-of-the-art facility in Auckland with controlled growing systems, integrated extraction site, advanced cannabinoid research laboratories and manufacturing operations. As regulatory reforms sweep across the world, Helius is prepared to set the standard for safe and effective medicinal cannabis products, made in New Zealand.
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Helius Therapeutics has a bold vision, to become a world leader in the research, development and production of next-generation cannabinoid medicines. Our team is innovating to create the world’s safest and most efficacious cannabis-based medicines
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):