In a statement today, the Medicinal Cannabis Agency has advised that transitional arrangements the country's Medicinal Cannabis Scheme will be extended for six more months.
Extending the Scheme's transitional arrangements will give local producers and importers more time to comply with New Zealand's new minimum quality standard for medicinal cannabis products. In the meantime, it will also ensure that prescribers and patients have continuity of access to some legacy CBD and THC products that have not yet been verified as meeting the new standards.
The Government says it remains committed to continuing patient access to prescribed medicinal cannabis products and has agreed to further extend the transitional period to 30 September 2021.
The Misuse of Drugs (Medicinal Cannabis) Regulations 2019 came into effect on 1 April last year. These regulations set a minimum quality standard for medicinal cannabis ingredients and products, and introduced a licensing regime to enable the establishment of a domestic industry to cultivate, manufacture and supply medicinal cannabis.
The regulations also provided for a transitional period to enable medicinal cannabis products that had already been imported into New Zealand as at 1 April 2020, to continue to be supplied without a product assessment until 1 October 2020. The transitional provisions were put in place to ensure that patients currently accessing these products were able to continue doing so while importers and suppliers provide evidence to the Medicinal Cannabis Agency to verify that their products meet the minimum quality standard.
Suppliers have indicated difficulties in providing evidence to establish that their existing products meet the quality standard, which is further complicated by COVID-19 affecting global supply chains. Cabinet have previously supported importers and suppliers to ensure that the supply of existing medicinal cannabis products was not disrupted, by extending the transitional period to 31 March 2021.
The Medicinal Cannabis Agency strongly recommend that importers and suppliers submit their completed product assessment applications to the Medicinal Cannabis Agency by 31 March 2021, to ensure that the assessment of the applications can be completed by the end of the transitional period on 30 September 2021.
Helius Therapeutics submitted applications late last year and will work with the Agency to assess and verify these over the coming weeks.
Health Minister Andrew Little says the transitional medicinal cannabis regulations will be extended as a result of COVID-19 and to ensure certainty of supply.
"The Government is committed to making the system work and continuing access to prescribed medicinal cannabis products for patients who need them," Andrew Little said.
Two products from one company have been verified under the new regulations. However the Government wants to see multiple suppliers for price competitiveness.
"COVID-19 restrictions have limited the abilities of companies to apply under the regulations, has affected global supply chains and also added challenges to suppliers seeking to have products assessed.
"I am mindful of the risk that wholesalers could suspend imports in advance of the April 1 deadline and this would prevent patients from accessing prescribed medicines.
By extending the deadline, patients will be still able to access products, while suppliers have the additional time they need to apply to the Medicinal Cannabis Agency for verification.
"The Government remains committed to bringing in the new regulation standards because patients and doctors deserve to know that medicinal cannabis products contain what the ingredient list says, are free from contaminants and are safe to consume," Andrew Little said.
The Misuse of Drugs (Medicinal Cannabis) Regulations 2019 came into effect on 1 April last year. The Regulations set a minimum quality standard for medicinal cannabis ingredients and products, and introduced a licensing regime to enable the establishment of a domestic industry to cultivate, manufacture and supply medicinal cannabis.
The Health Minister will request Her Excellency the Governor-General to sign the regulations extension on March 15.