Maseru – Lesotho’s top medical cannabis producer, MG Health, has been accredited to sell its cannabis flower, oil and extracts to the European Union.
MG Health CEO Mr Andre Bothma this week said the accreditation was granted after the company’s production processes were confirmed to be aligned to the EU’s Good Manufacturing Practice (GMP) standards. This makes Lesotho one of 20 countries in the world with GMP accreditation.
The basic principle of GMP is that quality control should be integrated into every batch of produce at all stages of the manufacturing process.
Mr Bothma said with the accreditation, MG Health was the only African company allowed to export medicinal cannabis as an active pharmaceutical ingredient (API) to the EU.
The accreditation was granted by the government of Upper Bavaria in Germany following a request for importation of medical cannabis products from MG Health by Drapalin Pharmaceuticals, a licensed importer and distributor in Munich.
“What it means is that we have authorisation to export our products as an API into Germany and the wider European market,” Mr Bothma said.
“To get the GMP, they want to see how you have validated your transport for the product and how you have packaged it. You do a test run before you get the certification.”
Mr Bothma went on: “The inspectors first came in 2019 to make preliminary assessments. They came back in February 2020 and did a detailed report. They had planned to come back in June 2020 for the final inspection but failed because of the Covid-19 travel restrictions and only came back in December 2020.”
Mr Luke van der Nest, MG Health’s business development manager, said they had deliberately targeted the German market.
“They’re one of the strictest regulators. We wanted to find the most stringent standards and make sure that we adhere to those, to generate that global confidence for patients, prescribing doctors and everyone else along the supply chain,” Mr van der Nest said.
According to the Cannabis Industry Journal, Germany is one of the biggest markets for medicinal cannabis products with at least 80 licensed distributors.
Mr Bothma said MG Health was also looking at entering France, the United Kingdom and Australia.
“It’s difficult to say how and when we can begin to expand but France is going to be another big market as well as the UK. We want to focus on supplying pharmaceutical companies around the world.”
Mr Bothma said the company had so far done two commercial transactions abroad. The first was of 50kg of cannabidiol flower shipped to Switzerland and another of 80kg of tetrahydrocannabinol to Israel.