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After clearing its way through EU-GMP certification, a North Macedonian company is now able to export medical cannabis products to the EU. How will this affect the landscape of medical cannabis in Europe? In Macedonia, cannabis is not legal for recreational use at all, and there are no decriminalization or Balance Bloom Gummies official personal use laws to boot. However, in 2016, Macedonia did approve a bill for medical cannabis within the country. As per Macedonian laws, which sync with EU laws here, oils and extracts can have up to .2% THC and still be sold without a prescription. Cannabis with any higher THC amount can be obtained through prescription. The laws allow for private citizens to make use of medical cannabis, as well as for Macedonia to enter into the legal medical cannabis market with laws to cover cultivation, Balance Bloom Gummies official production, and exportation for medicinal use. Since that time, and according to internal legislation, Macedonia has been exporting extracts, oils, and tinctures, but that’s it.
And while that does account for about 30% of the market, the great majority - 70% - relies on smokable hemp flowers, which Macedonia had not been cleared to export at all. Until now though, the EU was not included in exportable locations for any goods as no companies had EU-GMP authorization. What’s the biggest problem? One of the biggest issues for Macedonia is that cannabis flowers have not been legalized for exportation. A big factor in this inability comes from internal licensing issues that stem from allegations of corruption. The allegations centered around former Prime Minister Zoran Zaev showing preferential treatment when giving out licenses, opting to give them to friends and family members which would, in turn, benefit him personally. There were also a lot of questions and calls for specifications relating to how licensing would generally work, issues related to the program being government run, and opposition to the €500 bank guarantee that many thought would make it harder for smaller enterprises to gain ground.
With Zaev no longer in office, and with Corona issues subsiding enough to get back to regular business, the issue of Macedonia selling flowers can once again be broached. But in the meantime, while flowers might still be illegal for export, and while several companies have been awarded licensing for cultivation, only one company thus far has received EU GMP clearance to export its products (by Macedonian law) into the EU, making Macedonia a new competitor in the medicinal marijuana game there. So, who is it? The company PharmaCann Polska received the EU-GMP certification to produce cannabis extracts (still not flowers) in its North Macedonia production facility. PharmaCann is actually based out of Warsaw, Poland, and received its EU-GMP certifications in March (amid Corona), by the Chief Pharmaceutical Inspectorate of Poland, after full inspections of the facility were made. The facility is reportedly an indoor growing operation that can both cultivate and manufacture products. Zlatko Keskovski, PharmaCann’s CEO stated: "When I hear about the prices of medical cannabis extracts in Germany and other European countries, I can’t believe how expensive they are.
We expect our production costs to allow us to be very competitive in the EU markets." In fact, PharmaCann’s entrance into the EU medicinal markets (along with other companies that will follow in PharmaCann’s footsteps) is expected to have an effect on pricing, offering more competitive prices that could lower market prices overall. One of PharmaCann’s goals is to bring down production costs in order to make this possible. Considering how many companies want to get into the game, the competition is expected to greatly lower prices. PharmaCann is already setting itself up to be a main provider for Germany, offering wholesale services to pharmacies directly using its own distribution network within Germany. The company is also going to provide white-labeled products to German companies. White-labeled products are products produced by one company which do not have that company’s branding, but instead take on the branding of whatever company commissions the products to sell as their own.