AMA submission to the TGA Advisory Committee on Medicines Scheduling – proposals to down-schedule nabiximols

3 Oct 2018

The AMA opposes the down-scheduling of nabiximols from Schedule 8 to Schedule 4.

The delivery mechanism - a spray – has a similar effect to giving the medicine intravenously. This is an important contraindication for its down-scheduling to a less controlled category of medicine.

The AMA notes that the medicine has not been approved for listing under the Pharmaceutical Benefits Scheme.

The AMA is also not aware of any difficulties experienced by medical practitioners who wish to appropriately prescribe this medicine to their patients under the current scheduling arrangements, nor of patients having difficulty in accessing the medicine appropriately.