Third Medical Cannabis Product Approved In Ireland

Ireland medical cannabis - Tilray

Another product has been approved for use under Ireland’s Medical Cannabis Access Programme (MCAP).

Last year, Ireland’s Minister for Health signed legislation to commence a medical cannabis program that is to operate on a pilot basis for five years.

Currently very limited in its nature, MCAP is only open to patients with spasticity associated with multiple sclerosis and intractable nausea and vomiting associated with chemotherapy that doesn’t respond to conventional treatments. Additionally, severe refractory (treatment-resistant) epilepsy also qualifies.

Also limited are the number of approved medicines – or “products” as the Department of Health prefers to call them. Two products were approved for use last year –  High CBD Oil Drops from Aurora and CannEpil, which is produced by ASX-listed MGC Pharmaceuticals.

A third has now been added to the list; an oral solution from Canada’s Tilray – THC10:CBD10. It contains 9.6 milligrams per millitre of tetrahydrocannabinol and 10 mg/ml of cannabidiol. The product comes in a 40 mL bottle and uses coconut oil as a carrier. It’s pretty pricey stuff – costing CAD $86.00 in its homeland.

Tilray first delivered its product to Ireland for the necessary checks by local authorities in July last year.

There are a number of criteria for a product to be approved, including it being permitted to be sold or supplied for medical purposes by an EU member state other than Ireland. Oil based solutions cannot contain  more than 30mg/ml of THC in each dose and must be contained in packaging holding not more than 60ml in volume. For dried, ground or powdered flower product, it cannot contain more than 230 milligrams of tetrahydrocannabinol per gram and not be more than 5 grams total weight per pack.

Once approved, only registered medical consultants with specialist training in the qualifying medical condition can prescribe products, the cost of which will be covered by HSE under the MCAP program where the medicines are supplied through community pharmacies and other conditions met.

Depending on the circumstances of a patient, medical cannabis may be prescribed for up to 6 months.

The Department says approval of a product does not signify any endorsement by the Minister for Health as to the safety, quality or efficacy of it for the condition prescribed.