Published: 4 June 2020

Publications

Medicinal Cannabis Scheme – now operational

Prescriber Update 41(2): 40–41
June 2020

Medicinal Cannabis Agency Logo

 

The Medicinal Cannabis Scheme is now operational

The Medicinal Cannabis Scheme (the Scheme) started on 1 April 2020 with the commencement of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019. The Medicinal Cannabis Agency (the Agency) administers the Scheme, which includes a licensing regime for medicinal cannabis cultivation, manufacture and supply. The Scheme also includes the requirement for all medicinal cannabis products under the Scheme to consistently meet minimum standards of quality before they can be supplied.

Those who want to work in the industry need to hold a medicinal cannabis licence or work for a person or company that holds a licence. The licence specifies the types of activities that a licence holder may carry out, such as commercial cultivation of cannabis or manufacture and supply of medicinal cannabis products.

Medicinal cannabis products are prescription medicines and are only available to patients on prescription from a doctor.

Frequently asked questions

When will products be available to prescribe?

Doctors can prescribe SativexTM now for any indication (approved or unapproved) without needing to apply for approval to prescribe from the Ministry of Health. SativexTM is currently the only medicinal cannabis product that has been approved as a medicine under the Medicines Act.

Currently all other medicinal cannabis products are unapproved medicines, therefore they can only be prescribed by medical practitioners under the Medicines Act 1981. Doctors can prescribe medicinal cannabis products that have been verified by the Agency as meeting the minimum quality standard, but these will not be available immediately. The availability of new medicinal cannabis products depends on suppliers submitting evidence to the Agency to verify that their products meet the quality standard before they can be supplied.

In the meantime, the Scheme includes a transition period where medicinal cannabis products (including cannabidiol (CBD) products) that were imported and supplied prior to 1 April 2020 can continue to be supplied until 1 October 2020 without having to meet the quality standard. Suppliers have six months to submit evidence to the Agency to verify that their existing products meet the quality standard in order to continue to be supplied after 1 October 2020.

Does a doctor need a recommendation from a specialist before they can prescribe a medicinal cannabis product that meets the quality standard?

No, a doctor can prescribe any medicinal cannabis product that has been verified by the Agency as meeting the minimum quality standard. If a doctor is unsure whether to prescribe a product, they may choose to seek advice from their colleagues, but a recommendation from a specialist is not required before they can prescribe a product. Note that a product that has been assessed and verified as meeting the minimum quality standard does not mean that the product has been assessed for safety and efficacy. It remains an unapproved medicine.

How will healthcare professionals know which products meet the quality standard?

The Agency will publish a list of products which have been assessed and verified as meeting the quality standard on the Ministry of Health website (see the More information section below).

How can I find out more information on a particular medicinal cannabis product?

You can ask the medicinal cannabis product supplier for information. As they are unapproved medicines, suppliers are prohibited from advertising their products in any way, however they can respond to enquiries from healthcare professionals regarding their product(s). The Agency is encouraging suppliers of medicinal cannabis products to have product information available to provide to healthcare professionals who request it. Medicines data sheets will not be available from Medsafe unless the product has been assessed and approved as a medicine under the Medicines Act 1981.

What is the difference between hemp and cannabis?

Hemp and cannabis are both varieties of the Cannabis plant. However, the difference between them is the tetrahydrocannabinol (THC) content: hemp varieties have a low THC content. In New Zealand, hemp varieties of cannabis can be cultivated under an industrial hemp licence for industrial purposes (eg, for fibre) and must have a THC level of less than 0.35 percent dry weight. Cannabis plants, including hemp varieties, can be cultivated for medicinal cannabis purposes under a medicinal cannabis licence and there is no specified limit on the level of THC. Therapeutic products (ie, medicinal cannabis products) can be manufactured from the plants cultivated for this purpose.

Are hemp products that are available in health stores and the supermarket medicinal cannabis products?

No, these hemp products are not medicinal cannabis products. Hemp products often seen in health stores and supermarkets are made from hulled, low-THC hemp seeds (or the oil that is extracted) and are permitted to be in foods. Hemp seed products have limits on the levels of cannabinoids (eg, THC or CBD) permitted, and they cannot make therapeutic claims or state that they contain CBD or THC.

More information

The Ministry of Health website has information about the Agency and the Scheme. You’ll find information for industry (including guidelines and forms), health professionals and consumers. You can also subscribe to receive updates from the Agency.

Misuse of Drugs (Medicinal Cannabis) Regulations 2019

Prescribing unapproved medicines

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