- Biopharma company MGC Pharmaceuticals (MXC) has received formal approval for the sale of CannEpil in Ireland
- CannEpil is the company's formulation designed for targeting epilepsy
- The approvals have been officially granted by Irish Ministry of Health and will be one of the first cannabinoid-based medicines approved under the Irish Government's Medical Cannabis Access Programme
- MGC Pharma is currently up 3.03 per cent this morning with shares trading for 3.4 cents apiece
Biopharma company MGC (MXC) Pharmaceuticals has received formal approval for the sale of its CannEpil product in Ireland.
This follows the recommendation by the Health Products Regulatory Authority (HPRA).
These approvals have now been officially granted by the Irish Ministry of Health and will be one of the first cannabinoid-based medicines approved for prescription and sale under the Irish Government's Medical Cannabis Access Programme.
The Medical Cannabis Access Programme sits under The Misuse of Drugs Regulations 2019.
These regulations enable the importation, prescription and supply of cannabis-based products that have met specific requirements on quality and safety.
"Access to the Irish market is a key achievement for the company," MGC Pharma Managing Director and Co-Founder Roby Zomer commented.
"Not only does it allow MGC Pharma's GMP certified medical products to reach more patients in need, but can be seen as a catalyst for fast-tracking follow-on approval applications to prescribe in other EU member state countries such as Germany, Austria, Italy and France," he added.
CannEpil is a high CBD, low THC formula (20:1) used for treating epilepsy.
Approval from the Irish Ministry of Health enables the immediate sale of CannEpil in Ireland from MGC Pharma's EU-GMP certified production facility in Slovenia.
Following this approval, as in Australia and the U.K., import approval for MGC Pharma products will be granted per shipment into Ireland.
Importation through Ireland will be managed through MGC Pharma's U.K. distributors Grow Biotech PLC.
Grow Biotech is a British headquartered company that is developing industry-leading processes, tools, formulations, practices and techniques to bridge the gap between existing cannabis medicines and accepted pharmaceutical standards.
"The sale of CannEpil into Ireland is now able to commence, with the first shipment now imminent," Roby added.
"With an increasing number of patients being treated for drug-resistant epilepsy in Ireland, we believe that the high levels of demand from patients and doctors witnessed in the U.K. and Australia will be replicated in Ireland as doctors and patients familiarise themselves with MGC Pharma's high quality, affordable phytocannabinoid derived medicines," he concluded.
Now that CannEpil has been approved, MGC Pharma intends on leveraging the procedure for mutual recognition within the EU and key member states.
MGC Pharma is currently up 3.03 per cent with shares trading for 3.4 cents apiece at 11:37 am AEDT.