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Manufacture of medicinal cannabis for supply under 'approved access' provisions
Guidance on GMP compliance
Specific aspects relating to the manufacture and scheduling of medicinal cannabis
From 1 November 2016, the Poisons Standard (SUSMP) schedules medicinal cannabis products (under specified conditions) as Schedule 8: controlled substance. Where these conditions are not met, cannabis products are Schedule 9: prohibited substance.
The Schedule 8 status of medicinal cannabis puts specific requirements on the adequate administration of quantities of cannabis containing materials that you:
- hold in storage at any particular point in time
- supply (split up in recipients and shipments)
These requirements apply throughout all manufacturing processes, including all handling. The PIC/S Guide to GMP also includes requirements on recording quantities of materials and the reconciliation of these at the end of manufacture.
When manufacturing medicinal cannabis products, you can use one set of records and documentation that serves both purposes as long as these records comply with the GMP requirements as well as the requirements from the product's Scheduling.
The Schedule 8 status of medicinal cannabis also requires the manufacturer of medicinal cannabis products to verify that:
- Each supplier of medicinal cannabis containing goods holds current licence(s) and permit(s) under the Narcotic Drugs Act that allow the supply of each delivery to you.
- Each of the customers to which you supply medicinal cannabis products holds current licence(s) and permit(s) under the Narcotic Drugs Act that allow them to receive the delivery from you.
Both verifications are required to be conducted for each delivery and for each supplier or customer. The recommended way to meet these requirements is:
- include the verification of your supplier's narcotic drugs licence in the supplier qualification process that is required under GMP
- include the verification of the currency of that licence and the availability of the required narcotic drugs permits in your procedures on incoming goods receipt
- include the verification of your customer's narcotic drugs licence in your regular process to include customers in the customer database
- include the verification of the currency of that licence and the availability of the required narcotic drugs permits in your procedures on outgoing goods shipment.