MASERU – Lesotho could finally be on course to benefiting from its first mover advantage after leading medical cannabis grower MG Health announced acquiring accreditation to sell its products in the European Union (EU).
The tiny mountain kingdom was first in Africa to licence the growing of medicinal cannabis in 2017 and has now also become the first to get a good manufacturing practice (GMP) accreditation.
The GMP will allow the company to sell its cannabis flower, oil and extracts to EU countries. The achievement makes MG Health the only African company able to export medicinal cannabis flower as an active pharmaceutical ingredient (API) to the EU while Lesotho becomes only one of eight countries with a GMP accreditation worldwide. The other seven are Canada, Australia, Spain, Malta, Portugal, the Netherlands and Israel.
MG Health chief executive officer, Andre Bothma, announced the milestone last week.
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.
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.
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,” said Bothma.
“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.”
The accreditation could have been granted earlier but was delayed by the Covid-19-induced travel restrictions which deterred inspectors from travelling to Lesotho last year.
“The inspectors first came (to Lesotho) 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.”
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.
“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,” said van der Nest.
According to the Cannabis Industry Journal, Germany is one of the biggest markets for medicinal cannabis products with at least 80 licensed distributors.
Although Bothma could not be drawn into releasing projections, he said prospects were high that they could soon increase their workforce from the current 280 to about 3 000 while also increasing the company’s growing area from the current 5 000 square metres to about 10 000 square metres. The company currently produces 250kgs of packed cannabis monthly.
The expectation is that growth would be driven in high demand from 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,” he said.
MG Health, formerly known as Medigrow, was one of the first companies to get a medical cannabis licence in 2017. Since then, a growing number of countries around the world are either legalising or relaxing laws on cannabis. Among these are Zimbabwe, Rwanda, Malawi, South Africa and Morocco.
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 advised other players to be patient and be willing to learn.
“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.