Pursuant to Regulation 22 of the Misuse of Drugs Regulations 1977, I, Chris James, Group Manager, Medsafe, Ministry of Health, acting under delegated authority from the Minister of Health, hereby make the following approval effective from 1 April 2020:

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, and consented as a medicine from 19 November 2010 as Sativex Oral spray) may be prescribed, supplied, or administered in the following circumstances:

Prescribing

Medical practitioners registered with the Medical Council of New Zealand under the Health Practitioners Competence Assurance Act 2003 may prescribe Sativex for a patient under their care, within their scope of practice.

Supply

The following classes of persons may supply Sativex:

• A pharmacist registered with the Pharmacy Council of New Zealand under the Health Practitioners Competence Assurance Act 2003, in the course of their employment as a pharmacist, pursuant to a prescription issued by a medical practitioner described in this approval; or
• A medical practitioner registered with the Medical Council of New Zealand under the Health Practitioners Competence Assurance Act 2003, for a patient under their care.

Administration

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

Previous Approval Revoked

Approval No. 2016/AP305 (New Zealand Gazette, 1 December 2016, Issue No. 112, Notice No. 2016-go6803) is revoked on 1 April 2020.

Dated this 2nd day of March 2020.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health.