Australian Firm Wins License to Produce Cannabis-based Drugs in Slovenia (Feature)

By , 07 Mar 2018, 09:10 AM Business
Australian Firm Wins License to Produce Cannabis-based Drugs in Slovenia (Feature) Maxpixel CC0

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MGC Pharma works with the Ljubljana Faculty of Biotechnology, which grows cannabis intended for research and teaching. 

STA, March 7, 2018 – Growing medical cannabis is banned in Slovenia, but an Australian company is nevertheless pressing ahead. They are growing cannabis for research purposes in collaboration with the Biotechnical Faculty, and they recently acquired a limited licence to produce cannabis-based drugs.

After opening its first subsidiary in Slovenia several years ago, the Australia-based MGC Pharma has recently obtained a permit to produce cannabis-based drugs.

It was granted "a limited permit for the production of drugs in clinical testing", the Slovenian Agency for Medicinal Products and Medical Devices has told the STA.

While this allows it to produce drugs for clinical testing, it does not allow it to grow cannabis for medical purposes or distribute any cannabis-based drugs.

MGC could not tell the STA where the cannabis it uses for drugs for clinical trials comes from, saying its general manager was abroad.

According to the agency, cannabis for clinical tests could be grown in Slovenia because this is an unregulated field.

If MGC's drugs eventually obtain the agency's licence, they will be used exclusively for clinical trials.

This means they will be administered only to patients included in a clinical trial led by doctors in a medical organisation.

MGC would like to finance a clinical trial on treating children with severest forms of epilepsy, but the agency, which has to green-light all clinical trials, has not approved it yet.

The study would be carried out by UKC Ljubljana paediatric neurologist David Neubauer, who told the STA a year ago everything was ready for it to begin.

With all the legal restrictions and lengthy registration procedures, there is still a long way to go before a cannabis-based drug is put on the Slovenian market.

At the moment, MGC only has a permit to produce drugs for clinical trials, while to register a new drug it would also need a permit to produce drugs, for which a series of stricter conditions must be met.

Meanwhile, MGC Pharma also cooperates with the Ljubljana Faculty of Biotechnology, which grows cannabis intended for research and teaching.

On the basis of a permit the faculty received from the Health Ministry last year, it can carry out research in selective breeding of cannabis.

The permit was issued to facilitate research in plant breeding to increase the competitive edge of Slovenian producers and industry.

But according to the ministry, the permit does not mean the faculty can grow cannabis for medical purposes.

The company has also grown industrial hemp in Slovenia, as the Economy Ministry issued it a permit for 2016 and 2017, but explained that no such permit has yet been requested this year.

Finally, MGC also finances three clinical studies related to cosmetic products, testing how well cannabis could help reduce rash, dry skin and acne-prone oily skin.

While test results have not been revealed, they are reportedly encouraging.

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