On 1 August 2016, the Poisons and Therapeutic Goods Amendment (Designated Non-ARTG Products) Regulation 2016 (under the Poisons and Therapeutic Goods Act 1966) took effect.
This regulation allows doctors to apply to NSW Health to seek approval to prescribe certain cannabis-based products that are not on the Australian Register of Therapeutic Goods, in appropriate circumstances. These are products that have not been evaluated by the Therapeutic Goods Administration for quality, safety and efficacy.
Doctors will require approval from both the Commonwealth Therapeutic Goods Administration and NSW Health before they can prescribe an unregistered cannabis-based product.
An application from a doctor to prescribe must be accompanied by clinical evidence about use of the product to allow for an assessment of potential benefits and harms. It will also be expected that approved standard medicine or non-medicine treatments have already been utilised for the patient. The product must be legally produced and manufactured to appropriate quality standards.
Patients considering the use of cannabis-based products should ask their doctor whether a particular product could be appropriate for their needs. It is expected that prescribers will be specialists in the treatment of the condition for which the product is being requested.
For children, special approvals under the Children and Young Person's Care and Protection Act 1998 may apply, depending on the substance.
Information for prescribers and application forms are available here.
General information about the new arrangements is available here.
Relevant Commonwealth Government links