Tilray has become the first company to have products verified as meeting the minimum quality standards under New Zealand’s new medical cannabis system.
Tilray P Oral Solution CBD 100 and Tilray P Oral Solution CBD 25 have been deemed to meet the requirements under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019.
Tilray general manager medical ANZ George Polimenakos said: “[This is] great news for the industry and great news for New Zealand patients who will now be accessing GMP, pharmaceutical-grade cannabinoid products that meet Ministry of Health minimum quality standards.”
Under the scheme, medicinal cannabis products will generally only be available, on prescription, if they have been assessed by the Medicinal Cannabis Agency as meeting the minimum quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019, or have obtained consent for distribution under the Medicines Act 1981 (approved and provisionally approved medicines). Sativex Oral Spray has consent for distribution under the Medicines Act.
Any doctor can prescribe the approved products.
The regulations included transitional arrangements to give manufacturers and importers until October 1 2020 to collate the information required for product assessments and to ensure patients currently accessing those products could continue doing so.
The transitional period was then extended to March 31, 2021 amid fears firms would not be able to meet the deadline.
While it will still be possible for doctors to prescribe products that have not been assessed after the new deadline has passed, it will be more difficult and time-consuming to do so, with doctors required to coordinate the importation of the product on a named-patient basis.
- UPDATE (March 24, 2021): Tilray’s FS Oral Solution THC 10: CBD 10 is the first product containing THC to be verified as meeting New Zealand’s minimum quality standards. GPs and specialists can now prescribe the medicine for any indication without the need to send in an approval to the ministry of health (a first in the southern hemisphere).