…breaks into EU medical cannabis market

Silence Charumbira

LOCAL medical cannabis producer, MG Health, has scored big. This after being accredited to sell its cannabis flower, oil and extracts to European Union (EU) countries.

MG Health chief executive officer, Andre Bothma, announced the milestone at a weekend press briefing in Maseru. Mr Bothma said the GMP accreditation had been granted on 2 March 2021

He 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. It also makes Lesotho one of 20 countries with a GMP accreditation in the world.

Upheld by all EU member states, the GMP guidelines are the minimum requirements a manufacturer or producer must meet to ensure that products are high quality, consistent and safe for their intended use. The basic principle of GMP is that quality control should be integrated into each batch of the produce at all stages of the manufacturing process.

Mr Bothma said with the accreditation, MG Health becomes the only African company allowed to export medicinal cannabis as an active pharmaceutical ingredient (API) to the EU.

He said the accreditation was granted by the government of the Upper Bavaria district in Germany. This after a request for the import of medical cannabis products from MG Health was made by Drapalin Pharmaceuticals – a licensed importer and distributor based in Munich, Germany. Drapalin is the strategic partner of MG Health in Germany.

“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 said the accreditation could have been granted earlier but it was delayed by the Covid-19-induced travel restrictions which deterred inspectors from travelling to Lesotho last year.

“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 Bothma said.

Luke van der Nest, MG Health’s business development manager said they chose Germany for their accreditation because it is known in the medical cannabis industry to be exceptionally strict on the GMP rules.

“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 they were constantly receiving enquiries from that market and beyond.

He added that although they were being cautious, a massive expansion could be on the horizon to supply potential markets in France, the United Kingdom (UK) 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.

MG Health, formerly known as Medigrow, was one of the first companies to get a medical cannabis licence in 2017.

Mr Bothma said his company had amassed experience in the handling of the medical cannabis products particularly in terms of transportation of produce to the market. The shipping process is one of the key elements that must be validated before a company acquires GMP certification.

MG Health has so far done two commercial transactions abroad. The first was for 50 kilogrammes of cannabidiol (CBD) flower shipped to Switzerland last June and another last September for 80kgs of the tetrahydrocannabinol (THC) to Israel.

He counselled patience and willingness to learn for all those who have ventured into the industry.

“People do not fully understand this industry; some think they can buy a licence and make quick money but it is very difficult,” Mr Bothma said.