Notice of proposed changes to the minimum quality standard for medicinal cannabis
The Ministry of Health is seeking feedback to some proposed material to be incorporated by reference to the Misuse of Drugs (Medicinal Cannabis) Regulations 2019, which prescribes the minimum quality standard for cannabis-based ingredients and medicinal cannabis products.
Read more about the consultation in the Gazette notice:
Read the Gazette notice outlining the proposed changes (and how you can access these resources) can be found.
Due to copyright restrictions, we are not able to display a copy online or send you an electronic copy of the European Pharmacopoeia, the United States Pharmacopoeia-National Formulary, or the British Pharmacopoeia.
You can purchase these publications through the following links:
- The European Pharmacopoeia (version 11.0 including supplement 11.3)
- The United States Pharmacopoeia-National Formulary (2023 Issue 1)
- The British Pharmacopoeia 2023
If you have any comment on the proposal to incorporate the specified material by reference, please email [email protected] by Friday 8 September 2023.
Manatū Hauora – Ministry of Health has received approval to make changes to the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (the Regulations) to better support economic and research opportunities for the medicinal cannabis industry sector. The key changes are aimed at:
- broadening the types of cannabis plant forms that can be considered ‘starting material’ and ‘cannabis-based ingredient’
- enabling the export of cannabis seed under the Medicinal Cannabis Scheme
- enabling export of starting material, cannabis-based ingredients and medicinal cannabis products (without needing to meet the minimum quality standard) for the purposes of testing, analysis or research
- enabling import of cannabis-based ingredients and medicinal cannabis products (without needing to meet the minimum quality standard) for the purposes of testing, analysis or research
- removing the requirement for consignments of starting material to meet the minimum quality standard before export
- removing the requirement for cannabis-based ingredients and medicinal cannabis products to meet the minimum quality standard before export if they are manufactured to Good Manufacturing Practice (GMP) and meet the quality requirements of the importing country
- allowing a licence to possess controlled drugs (issued under the Misuse of Drugs Regulations 1977) to authorise non-therapeutic research activities using medicinal cannabis or industrial hemp.
Agreement has also been given to making a number of minor technical changes to update and clarify the minimum quality standard. Examples of these include:
- updating pesticide requirements
- broadening the permitted pharmacopeial tests, excipients and container material requirements
- broadening laboratory accreditation requirements for some tests
- reducing areas of duplicative testing.
Manatū Hauora will publicly consult on any material that will be incorporated by reference (such as pharmacopoeial material) into the Regulations.
Following consultation, Manatū Hauora will commence drafting amendment regulations to bring these changes into effect, with the aim to have these in place by the end of 2023 (subject to approval).