MEDICAL cannabis could be a boost to the North Macedonian economy, with NYSK and PharmaCann Polska – both subsidiaries of Warsaw-based PHCann International – leading the way.
PHCann International’s CEO Zlatko Keskovski and the group’s founder and director, Yuval Soiref, tell Jane Hall about their plans.
NYSK HOLDINGS has notched up a lot of firsts since it was founded five years ago.
It was the first North Macedonian company to be granted a licence in February 2017 for the cultivation of cannabis for medicinal purposes.
In June 2017, NYSK obtained the first approval for the extraction and processing of cannabis dry flower.
EU-GMP Recognition
In March 2020 it secured EU-GMP certification via the Polish Chief Pharmaceutical Inspectorate after its sister company, PharmaCann Polska, became the first to obtain the coveted good manufacturing practice standard to produce medical cannabis extracts at NYSK Holdings’ maiden facility in North Macedonia.
It is the first and only North Macedonian company with a European licence for the production of pharmaceutical products based on cannabinoids.
Now NYSK has become the first North Macedonian concern to receive a licence to export dried cannabis flowers into the EU as an active pharmaceutical substance. Intended for the Polish market, the move opens up a wealth of possibilities for NYSK Holdings, PharmaCann Polska and their parent company PHCann International.
NYSK founder and PHCann International’s Chief Executive, Zlatko Keskovski, describes it as a ‘game changer’, a ‘huge milestone for us as well as North Macedonia’. He said: “We have been waiting for many years to get this export licence and now it is finally here.”
€20m Investment
Announced earlier this month, the granting of the all important licence is the result of five years hard work and more than €20m of investment, which includes the opening last autumn of PHCann International’s second North Macedonian cannabis production facility, a 17,800sq metre state-of-the art complex in the capital, Skopje.
Here, inside a compound surrounded by a high security fence, cannabis plants are raised under purple heat lamps before being transferred to the flowering rooms.
Until now companies operating in North Macedonia have only been able to sell extracts, such as oils, that are more expensive expensive and time-consuming.
Whilst some 60-odd ventures have secured licences to grow cannabis, NYSK Holdings is one of the few that has had both the financial backing and expertise to produce extracts that meet the EU’s high pharmaceutical standards.
It has created a niche for itself by successfully producing dry cannabis flower products and distillates with a wide scope of Tetrahydrocannabinol (THC) and CBD concentrations, as well as crystals and other pharmaceutical goods.
NYSK’s technical experience allows it to control the THC content of its oils, ranging from 0.2% to a very high 95%-plus. White label extracts and high potency distillates are exported for other companies to dilute and create their own branded products.
Dried Flower Export Milestone
But the dried flower export licence takes not only NYSK’s operations to a new level, but also those of PharmaCann Polska and PHCann International.
For one thing, it will open the door to an additional €15m of investment for NYSK, creating 150 jobs in the next 12 months on top of the 90 already employed.
Dried cannabis flower makes up most of the European market and is a lucrative source of income.
Mr Keskovski had feared his homeland might miss out to rivals Malta and Greece, both of which are hoping to cash in on the European market, which is expected to be worth €3.2bn by 2025, according to recent research by Prohibition Partners.
“The market is massive, but we have competition,” he said.
Exporting the dried flowers to certain countries will rely on PHCann International gaining EU-GMP validation, qualification and inspection approvals for its new facility, built in anticipation of NYSK gaining the export licence.
Assessment is expected to take place in September, and Yuval Soiref, founder and director of both PharmaCann Polska and PHCann International, says he is confident everything will be signed, sealed and delivered to their satisfaction by the end of this year.
In the meantime, PHCann International is targeting those countries for whom dried flower EU-GMP approval is not an issue.
Soiref says: “It depends on the country. Some countries do require EU-GMP for export, but countries like Australia do not require EU-GMP for the flowers. So, we will be able to begin exporting to some countries, but not as many as we may like to.
“You have countries where you need to have the EU-GMP for the drying process as well, so we will be limited until such a time as we have that. But we are confident it will come.”
Europe Dominant in Five Years
As evidence grows of cannabis’ therapeutic benefits for treating a variety of diseases and conditions, Mr Keskovski expects Europe to become the largest medical cannabis market in the world in the next five years.
However, there are still only a limited number of European-based facilities producing high-quality, cannabinoid-based products.
Mr Keskovski believes the new facility near Skopje airport will enable PHCann to meet demand from the UK, Germany, Poland and other countries that are starting to adopt pharmaceutical cannabis in the EU, as well as international markets such as Australia, Brazil and Israel.
The plant boasts an integrated and fully-equipped cannabinoid research and testing quality control laboratory to study the microbiology and stability data of cannabinoids in all forms according to German standards, and has an annual flower production capacity of up to 15,500kg.
It also manufactures active pharmaceutical ingredients in herbal form and exports finished medical cannabis products, including dried flower and oils, to global markets.
These include Australia, Brazil, Croatia, Slovenia, South Africa and the UK.
Oils For Poland
Confirmation is expected soon that PHCann will be the first company to get its oils into Poland; New Zealand and Ireland are opening up; and North Macedonian products are also available in the notoriously difficult to crack German market, which has accepted NYSK’s EU-GMP certification from the Polish Chief Pharmaceutical Inspectorate.
They inspected the original indoor facility where NYSK both grows and manufactures the extracts, in December 2019 before issuing approval in March last year. The whole process took 12 months.
Mr Keskovski says: “In this industry the conditions are very strict. There are not a lot of companies that get it. It was a very expensive process, and a very hard process that required a lot of knowledge, a lot of input from pharmaceutical experts and the right designed facility with the right people and controlled environment. But it was very important that we got it.
“It means that we can reach any market worldwide. Some countries require it and some don’t, but it is proof that your processes and products are of the highest standard.”
Umbrella Company
NYSK Holdings and PharmaCann Polska joined forces in 2019 under the umbrella company PHCann International as they looked to reap the rewards of their combined strength, reach new markets and patients across Europe and worldwide, and circumvent legal restrictions in their own countries.
In 2017 Poland became one of the first countries in Europe to provide cannabis-based medicines through pharmacy chains for a limited number of conditions. The regulations allow cannabis from imported plants to be distributed through pharmacies as long as it has been registered with the country’s Office for Registration of Medicinal Products.
Meanwhile, North Macedonia had legalised the cultivation and sale of marijuana derived medical products in 2016 as it looked to gain the edge in what is a fast developing European trade sector.
Both Mr Keskovski and Mr Soiref are expecting the UK to be one of the biggest markets in the next 12 months, second only to Germany.
Mr Soiref adds: “With PHCann leading the way, North Macedonia is now on the map for producing pharmaceutical-grade medical cannabis, and our vision is to become one of the largest providers of medicinal cannabis to the EU and other global markets.”
