MGC Pharma expects the approval to expedite the licensing process in further EU member states.
MGC Pharmaceuticals Ltd (ASX: MXC) expansion into Europe has continued, after the company announced that it had secured formal approval for the sale of CannEpil in Ireland, following a recommendation from the Health Products Regulatory Authority (HPRA).
Approval for CannEpil was officially granted by the Irish Ministry of Health, making it one of the first cannabinoid-based medicines approved for prescription and sale under the Ireland's Medical Cannabis Access Programme.
CannEpil is one of MGC Pharma's flagship Investigational Medicinal Product's (IMP)—which uses a high CBD, low THC (20:1) formulation—and was developed to treat drug resistant epilepsy.
"The sale of CannEpil® into Ireland is now able to commence, with the first shipment now imminent. 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 UK and Australia will be replicated in Ireland as doctors and patients familiarise themselves with MGC Pharma's high quality, affordable phytocannabinoid derived medicines." MGC Pharma Managing Director and Co-Founder, Roby Zomer
The approval allows for the prescription of CannEpil— which is manufactured in the company's EU-GMP certified production facility in Slovenia—in Ireland, effective immediately.
This is big news for the company, as Ireland is a key EU member state country, which means the approval will add further legitimacy to the company's medicinal products in the European market. MGC Pharma's management also expects CannEpil's entry into the Irish market to accelerate the approval process in other EU member states, due to "mutual recognition".
MGC Pharma's distributor in Ireland is already in contact with Irish doctors who are interested in prescribing the drug, as the country has seen a gradual year-on-year increase in the prevalence of treated epilepsy.
According to the Co-Founder and Managing Director of MGC Pharma, Roby Zomer, successfully achieving access to the Irish market, "is a key achievement for the company."
"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."
"With distribution agreements already in place across Europe, we are well positioned for a quick entry to these markets following receipt of the required approvals," Zomer said.
Importation of CannEpil into Ireland will be managed by the company's UK distributor, Grow Biotech PLC.
To learn more about MGC Pharmaceuticals visit their Company HQ here.
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Disclaimer: past performance is not an indicator of future performance
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