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

It is proposed that the Medicinal Cannabis Quality Standard incorporates by reference the test methods and specifications set in the general monograph Pharmaceutical Preparations (2619) of the European Pharmacopoeia.

The proposed Medicinal Cannabis Quality Standard and the material incorporated by reference can be inspected free of charge during normal working hours (8.00am – 4.00pm, Monday to Friday) at the Ministry of Health, 133 Molesworth Street, Thorndon, Wellington. To arrange an appointment between Monday 21 October and Monday 11 November 2019, please email medicinal.cannabis@health.govt.nz.

Under copyright law, we are not able to display a copy online or send you an electronic copy of the European Pharmacopoeia.

The 10th edition of the European Pharmacopoeia can be purchased at:

https://www.edqm.eu/en/european_pharmacopoeia_10th_edition#The%20Ph.%20Eur.%2010th%20Edition%20is%20available%20in%20print%20and%20electronic%20versions.

If you have any comment on the proposal to incorporate the general monograph Pharmaceutical Preparations (2619) by reference, please email medicinal.cannabis@health.govt.nz by Monday 11 November 2019.

Dated this 20th day of October 2019.

ASHLEY BLOOMFIELD, Director-General of Health.