The Ministry of Health proposes to make regulations under section 37A of the Misuse of Drugs Act 1975, which will set the Medicinal Cannabis Quality Standard.

It is proposed that the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 incorporates by reference the stability testing parameters as set out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q1A (R2) Stability Testing of New Drug Substances and Products (ICH Q1A).

The material above proposed to be incorporated by reference can be inspected free of charge online at www.ema.europa.eu/en/documents/scientific-guideline

If you have any comment on the proposal to incorporate the stability testing parameters set out in the ICH Q1A guideline, please email medicinal_cannabis@health.govt.nz by Wednesday 27 November 2019.

Dated this 19th day of November 2019.

ASHLEY BLOOMFIELD, Director-General of Health.