Yesterday the Minister of Health, Hon David Clark, announced that the Government had passed regulations to enable the cultivation, manufacture, and supply of medicinal cannabis products. The Misuse of Drugs (Medicinal Cannabis) Regulations 2019 ("Regulations") will come into effect on 1 April 2020.
The Regulations will introduce a new licensing regime to ensure that cannabis and cannabis products are cultivated and manufactured only for medicinal purposes.
Under this regime there will be a single, overarching medicinal cannabis licence to cover all medicinal cannabis-related activities. Applicants may apply for a licence to undertake multiple activities in the medicinal cannabis supply chain, including:
- research activity involving the supply or administration of a medicinal cannabis product in clinical trials;
- the cultivation of medicinal cannabis and related cultivar and breeding research;
- the manufacture of medicinal cannabis products and cannabis-based ingredients, and the laboratory testing of those products and ingredients;
- the domestic supply of medicinal cannabis products and cannabis-based ingredients, and the export of those products and ingredients; and
- the operation of a nursery and the supply of cannabis seeds to licence cultivators.
There are fees associated with the assessment of the licence application and for each activity proposed to be undertaken under the licence. Licences must be renewed annually.
New Zealand resident individuals, partnerships and companies are eligible to apply for a licence. As expected, applicants must undergo a screening process and satisfy several eligibility criteria in order to have their licence approved. Among other things, these criteria bar applicants that have:
- been convicted of an offence against the Misuse of Drugs Act 1975, or of any other drug-related offence; or
- held a licence issued under the Misuse of Drugs Act 1975, or any regulations made under that Act, that has been revoked.
Licensees must comply with strict record keeping requirements, implement appropriate security arrangements in relation to their licensed premises and products manufactured under licence, and make each available for inspection by Ministry of Health officials.
The Regulations will also require all medicinal cannabis products and their precursors (including those intended for export markets) to comply with a New Zealand minimum quality standard. The products permitted for manufacture under the new Regulations include dried cannabis and "cannabis-based ingredients" in a pharmaceutical dosage form, such as a tablet, capsule, or a liquid intended for oral administration.
The New Zealand minimum quality standard incorporates the European Pharmacopoeia for the manufacture of medicines and pharmaceutical ingredients, which provides various requirements relating to medicinal dosage forms, container materials, excipients, and testing methods. Alignment with the European Pharmacopoeia will position New Zealand cultivators and manufacturers to be able to compete internationally with other European countries that have adopted the same controls in relation to medicinal cannabis products.
All product testing carried out in accordance with the European Pharmacopoeia must be undertaken by manufacturers or laboratories certified as compliant with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods.
A new regulatory agency will soon be established within the Ministry of Health to monitor compliance with the minimum quality standard, and administer the new licensing regime. In line with the commencement of the Regulations, this new regulatory agency is expected to be operational and ready to receive license applications on 1 April 2020. The first medicinal cannabis licences are expected to be issued by mid-2020.
Further detail on the licensing regime and minimum product standard can be accessed on the Ministry of Health's website, here and here.
This article is intended only to provide a summary of the subject covered. It does not purport to be comprehensive or to provide legal advice. No person should act in reliance on any statement contained in this publication without first obtaining specific professional advice. If you require any advice or further information on the subject matter of this newsletter, please contact the partner/solicitor in the firm who normally advises you, or alternatively contact one of the partners listed below.