Published: 17 October 2023

Committees

Reclassification of low-dose cannabidiol

Medsafe has reclassified cannabidiol (CBD) from a prescription-only medicine to a restricted (pharmacist-only) medicine. The reclassification will allow supply of approved low-dose CBD medicines, by registered pharmacists, without prescription for patients aged 18 years and older under certain conditions. Only CBD medicines approved under the Medicines Act 1981 will be available from a registered pharmacist.

CBD is a cannabinoid that naturally occurs in the Cannabis sativa L. plant. CBD has little-to-no psychoactive effects.

CBD was previously classified as a prescription-only medicine. The new classification of CBD is as follows.

Prescription: except when elsewhere in the schedule.

Restricted (Pharmacist-only): when supplied, in medicines with dosing instructions for 150 milligrams or less per day and containing not more than 4.5 grams, when sold in the manufacturer’s original pack that has received consent from the Minister or Director-General, for adults aged 18 years and over, by a registered pharmacist.

Reclassifying low-dose CBD harmonises with the Australian Therapeutic Goods Administration’s decision, in December 2020, to down-schedule low-dose CBD-containing products for supply by pharmacists under certain circumstances. The decision follows careful consideration of the risk-benefit profile of access to low-dose CBD by Medsafe.

There are currently two routes for supplying CBD in Aotearoa New Zealand: as a medicinal cannabis product which meets the minimum quality standards of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019, or as medicine approved under the Medicines Act 1981. As described above, the reclassification of low-dose CBD will only apply to those medicines approved under the Medicines Act 1981.

There are currently no low-dose CBD containing medicines approved under the Medicines Act 1981. However, those in CBD industry have previously signaled that a change in classification may allow greater opportunities for research into the clinical efficacy and safety of CBD and subsequently greater opportunities for the approval of low-dose CBD medicines.

Medsafe welcomes applications for low-dose CBD containing medicines, provided they meet the New Zealand regulatory guidelines for approval of new medicines.

Should consumers, healthcare professionals, or those in pharmaceutical industry be unsure of what this change in classification means for them, please email Medsafe at: committees@health.govt.nz