ASX-listed MGC Pharmaceuticals has been given the green light by Slovenian authorities, who have given the medical marijuana company’s European medicinal cannabis production facility a tick of approval. The company has now cleared an important regulatory hurdle for the production of its products in Europe, whilst it also steps up the approvals process for the import of medicinal and beauty brands into Australia.
Medical marijuana player MGC Pharma said in a market update last week that an interim licence for its European medicinal cannabis production facility had been granted by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia. Slovenian authorities inspected the facility during January before granting a penultimate approval certificate that brings an important 18-month process to the brink of closure for the company.
The latest approval sets MGC Pharma on a pathway towards the production of CannEpil, the company’s first pharmaceutical-grade medical cannabis product to be used for the relief of drug-resistant epilepsy, also known as refractory epilepsy. This form of epilepsy accounts for approximately 30% of the estimated 240,000 people diagnosed with epilepsy in Australia each year, the company said.
MGC Pharma said, ‘This full GMP licence will enable MGC Pharma to commence full-scale manufacture and to be licensed for distribution of CannEpil as well as other pharmaceutical grade medicinal cannabis products.’
‘GMP certification provides MGC Pharma with a significant competitive advantage to access key European and global markets, to be one of the most advanced medicinal cannabis production facilities in Europe.’
The interim licence for the facility is expected to be upgraded to full certification once the first batch of CannEpil has met additional protocols defined by a post-production validation process.
MGC also announced it had signed an agreement with specialist Australian pharmaceutical distributor HL Pharma to bring CannEpil to the Australian market. Under the agreement MGC Pharma will be responsible for securing Therapeutic Goods Administration and Office of Drug Control approval to import and supply the products in Australia.
Management said that upon satisfying Australian regulatory approvals, the supply of CannEpil to the Australian market is set to generate expected revenues of approximately $1m per annum for MGC shareholders from its first full year of distribution. The company said through its relationship with Epilepsy Action Australia, it already had 100 patients registered for the drug.
Roby Zomer, co-founder and CEO of MGC Pharmaceuticals said, “MGC has a vision and defined strategy of becoming a leading pharmaceutical-grade medicinal cannabis company and the receipt of GMP certification for our European manufacturing facility is a key milestone on this journey. Once we receive full certification, we will be positioned to rapidly progress our operations in Europe with a core focus on medicinal research and development of the company’s pharmaceuticals products pipeline.”