You will need a ‘supply’ activity specified on your licence if you intend to supply or export starting material, cannabis-based ingredients, or medicinal cannabis products.
Products intended for supply or export for therapeutic use must meet the medicinal cannabis minimum quality standard.
The ‘supply’ activity does not allow you to provide medicinal cannabis products or cannabis-based ingredients directly to individuals. Patients cannot access medicinal cannabis products without a prescription from their doctor and must visit a pharmacy to fill their prescription.
Procedures and protocols
To minimise any risks to consumers and ensure timely responses to product issues, the Medicinal Cannabis Agency expects you will have:
- procedures to manage complaints and recalls
- procedures for effective batch release and tracking of distributed stock
- protocols for responding to enquiries from media, consumers, healthcare professionals and other interested parties
- procedures to advise the Medicinal Cannabis Agency of emerging issues such as recalls, withdrawals or the suspension of market authorisation in other jurisdictions.
You will also need to be familiar with the safety-related actions set out in the New Zealand Medicines and Medical Devices Recall Code.
If you hold a medicinal cannabis licence with a ‘supply’ activity, (or a licence under the Medicines Act 1981 for CBD products you will need to apply to the Medicinal Cannabis Agency for a product assessment before you can supply any:
- medicinal cannabis product intended for use by patients
- cannabis-based ingredients
- shipment of starting material for export
The product assessment must be completed, and the product must be specified on your licence, before you can make the product available for supply or export.
Supplying starting material, cannabis-based ingredients or medicinal cannabis products for export
If you intend to supply starting material, cannabis-based ingredients or medicinal cannabis products for export, you will need to obtain licence to export a controlled drug for each consignment. You also need to make sure that an import licence is issued by the importing country.
Cannabis ‘starting material’ exported for extemporaneous compounding (for example, in magistral or officinal preparations) is considered to be a finished product and will be required to meet the minimum quality standard prior to export. You will need to meet GMP requirements and hold a licence to manufacture medicines, or a licence to pack medicines, under the Medicines Act 1981.
Supplying cannabidiol (CBD) products
You do not need a medicinal cannabis licence to supply CBD products. However, a licence under the Medicines Act 1981 is required.
Read more about CBD products.