Pursuant to Regulation 22 of the Misuse of Drugs Regulations 1977, I, Michael Haynes, Manager, Medicines Control, Ministry of Health, acting under delegated authority from the Minister of Health, hereby make the following approval effective from 1 December 2016:

That Sativex (a pharmaceutical grade cannabis-based product classified as a controlled drug under Schedule 2, Part 1 of the Misuse of Drugs Act 1975) may be prescribed, supplied or administered in the following circumstances:

Prescribing

The following classes of persons may prescribe Sativex for a patient under his or her care:

• Medical practitioners with a vocational scope of practice of Internal Medicine (specialising in neurology), registered with the Medical Council of New Zealand under the Health Practitioners Competence Assurance Act 2003, for the treatment of multiple sclerosis; or
• any other medical practitioner registered with the Medical Council of New Zealand when acting on the written recommendation of one of the medical practitioners with the vocational scope described above, for the condition specified. The name of the recommending medical practitioner with the appropriate vocational scope must be endorsed on the prescription form.

The prescriber is required to state the condition being treated (ie “multiple sclerosis”) on the prescription form.

Supply

A pharmacist registered with the Pharmacy Council of New Zealand under the Health Practitioners Competence Assurance Act 2003, in the course of his or her employment as a pharmacist, may supply Sativex pursuant to a prescription issued by any of the medical practitioners described in this approval if the prescription meets the conditions below:

The prescription must:

• state the condition being treated (ie “multiple sclerosis”); and
• have the name of the recommending medical practitioner holding the vocational scope described above endorsed on the prescription (where the prescription is not written by the medical practitioner with the vocational scope described above).

Administration

Any person who is caring for a patient, for whom Sativex has been prescribed by any of the medical practitioners described in this approval, may administer the product to that patient in accordance with the prescribed directions for use.

Dated at Wellington this 29th day of November 2016.

MICHAEL HAYNES, Manager, Medicines Control, Ministry of Health.