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Manufacturing for supply – medicinal cannabis licence
If you intend to manufacture medicinal cannabis products, your licence must specify the ‘possess for manufacture’ activity.
Your licence must also specify a supply activity before you can supply any of your manufactured products. The licence lists the specific products you are authorised to supply.
Licence to manufacture medicines under the Medicines Act 1981
In addition to your medicinal cannabis licence, you will also need to hold a Licence to manufacture medicines issued under the Medicines Act 1981.
If your planned activities are limited to re-packing products that have been manufactured by a GMP-compliant facility and verified to meet the medicinal cannabis minimum quality standard, a Licence to Pack Medicines is required instead of a Licence to Manufacture Medicines.
To obtain either licence, you will need to demonstrate compliance with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (the Code of GMP).
For further information, refer to the Medsafe guidance on manufacturing medicines and the Guideline on the Regulation of Therapeutic Products in New Zealand: Manufacturing of medicines.
Please also see the Guideline on the Regulation of Medicinal Cannabis in New Zealand: Information for New Zealand Manufacturers and Packers for information about GMP, the GMP audit process and responsibilities of Medicines Act licence holders.
Any products intended for patient use in New Zealand will also need to meet the Medicinal cannabis minimum quality standard.
Laboratory testing
If you hold a licence with a possession for manufacture activity, you may perform laboratory testing of medicinal cannabis, starting material, cannabis-based ingredients, and medicinal cannabis products or develop test methods.
If you are testing medicinal cannabis products to determine whether they meet the medicinal cannabis minimum quality standard, your facility will need to be certified under the Code of GMP for the critical tests. You may be certified to ISO for the non-critical tests. Read more.
If you are an independent laboratory that tests products only for regulatory purposes and not to develop medicinal cannabis products, your testing activities may be able to be performed under a licence issued under the Misuse of Drugs Regulations 1977 and a medicinal cannabis licence is not required.
Contact Medicines Control for further information.
