Delivered 6 November 2020
This update outlines decisions made on CBD products not derived from cannabis (including synthetic CBD products) and what this means for suppliers and prescribers.
The Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (the Medicinal Cannabis Regulations) came into force on 1 April 2020. Part 1 of these regulations sets the minimum quality standard that cannabis-derived medicinal cannabis products must meet. These regulations also amend the Medicines Regulations 1984 to require all products that meet the definition of a CBD product to meet the minimum quality standard. A CBD product is defined in section 2A of the Misuse of Drugs Act 1975.
The Medicinal Cannabis Agency has reviewed the suitability of applying the minimum quality standard to non-cannabis-derived CBD products, which were inadvertently captured in the Medicines Regulations amendments. The Agency has decided that the minimum quality standard in the Medicinal Cannabis Regulations is not suitable for assessing non-cannabis-derived CBD products and that it is unreasonable to require suppliers to comply with this standard.
This means that CBD products that have been synthetically manufactured or isolated other than from cannabis (ie, non-cannabis-derived CBD products):
- are not required to comply with the minimum quality standard
- must still be included on a licence to manufacture medicines, licence to pack medicines, licence to sell medicines by wholesale or a licence to operate pharmacy for that licence to apply to the CBD product
- must not be labelled as a medicinal cannabis product
- cannot be included on the list of products assessed as complying with the minimum quality standard on the Ministry of Health website
- cannot be exported in the course or for the purpose of sale
- can be compounded by a pharmacist in a pharmacy or hospital
Personal imports of non-cannabis-derived CBD products are not permitted.
Additional information for prescribers
The minimum quality standard is not appropriate for assessing the quality of CBD products that are not derived from cannabis. While this decision changes the way non-cannabis-derived CBD products can be accessed, it does not change how they are prescribed. If you wish to prescribe a non-cannabis-derived CBD product, you will need to assess the quality of the product to determine whether it is appropriate to be prescribed for a particular patient.
Currently, no non-cannabis-derived CBD products have been approved as medicines by Medsafe. The medical practitioner takes responsibility for balancing the potential risks and benefits for the patient and must seek informed consent from the patient. Medical practitioners should consider the need to use an unapproved medicine, and whether there is an acceptable benefit-risk balance for use of the medicine in the clinical situation.
For a full description of your obligations when prescribing unapproved medicines, please see the Medsafe website.
The Medicinal Cannabis Agency has received applications for the assessment of Medicinal Cannabis Products and are in the process of verifying the products against the minimum quality standard. When products are verified as meeting the minimum quality standard, they will be listed on the Ministry of Health website.
There are currently no CBD products that have been approved as medicines by Medsafe or verified as meeting the minimum quality standard by the Medicinal Cannabis Agency.