Last month, Slovenia’s parliament passed a law to significantly open up access to medical cannabis, coinciding with the presentation of a separate draft law on legalisation for personal use.
While cannabis has been classified as a substance with potential therapeutic uses since 2017, until now, it could only be prescribed with a special prescription, meaning patients and prescribing doctors faced numerous restrictions.
Furthermore, domestic cannabis production lacked a clear framework, meaning all of the cannabis products available had to be imported from abroad.
Now, under its new legislation, Slovenia has introduced a tightly controlled system that allows licensed pharmaceutical manufacturers to cultivate cannabis under state supervision, but keeps home cultivation by private individuals prohibited for now.
A crucial element of this bill, similar to the current situation in Germany, is that doctors will be able to prescribe medical cannabis for any condition, meaning that the doors have been flung open to access for patients.
Restrictions still apply, however. Patients will only be able to secure a maximum one month’s supply at a time from prescribers. Patients must also undergo at least one annual medical examination to continue treatment.
Another critical element is that extracts, resins and raw cannabis plants ‘intended for medical use’ are set to be removed from the list of prohibited drugs, a move that has seen Germany’s medical cannabis market explode in size.
There is nuance to this change, though. THC, cannabis’s psychoactive compound, will remain a controlled substance, but will be permitted only when being used in medical or scientific contexts.
Any handling of THC outside these defined uses will continue to fall under drug control legislation. The law goes some way to distinguishing non-psychoactive cannabinoids from THC, but how this will work in practice remains to be seen.
To protect patients from penalties, those prescribed cannabis will receive a “cannabis card” alongside their medicine, allowing them to prove their legal access during checks.
According to the Slovenia Times, the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) is responsible for managing the licensing process for production permits and permits for the trade of medical cannabis.
MP Sara Žibrat from the Freedom Movement called the law ‘revolutionary’ when it was passed in July, as it seeks to prevent monopolies in the production and cultivation of cannabis for medical purposes from being formed, but enables any company that meets the legal requirements to apply for a license.
Production of medicinal cannabis and related medicines will be subject to rigorous quality requirements, including compliance with GACP, GMP, and European Pharmacopoeia standards, which regulate the quality, manufacture, and testing of medicines.
The aim is to ensure a stable and reliable supply of cannabis via pharmacies, licensed wholesalers, and healthcare providers, while reducing dependence on imports and inconsistent access. The law entered into force on 20 August 2025.
The Minister of Health must now set out further technical rules within six months, including requirements for securing cultivation sites, conditions for granting production licences, and mechanisms for monitoring production. During the same period, the ministry must also establish detailed criteria for marketing authorisations and trade supervision.
Regulations on the classification, prescription, and dispensing of human medicines must be harmonised with the new law within 90 days, while JAZMP has 18 months to establish the technical infrastructure for electronic patient and production records.
Industry analysts forecast annual market growth of up to 4%, with Slovenia’s medical cannabis sector projected to reach €55 million by 2029.
The Medical Cannabis Act entered into force 15 days after its publication in the Official Gazette on 20 August 2025, following a parliamentary vote of 50 in favour and 29 against. The measure was strongly backed by the governing left-liberal coalition, while the conservative opposition opposed it.
The post Inside Slovenia’s New ‘Revolutionary’ Medical Cannabis Law appeared first on Business of Cannabis.
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While cannabis has been classified as a substance with potential therapeutic uses since 2017, until now, it could only be prescribed with a special prescription, meaning patients and prescribing doctors faced numerous restrictions.
Furthermore, domestic cannabis production lacked a clear framework, meaning all of the cannabis products available had to be imported from abroad.
Now, under its new legislation, Slovenia has introduced a tightly controlled system that allows licensed pharmaceutical manufacturers to cultivate cannabis under state supervision, but keeps home cultivation by private individuals prohibited for now.
Medical cannabis for any indication
A crucial element of this bill, similar to the current situation in Germany, is that doctors will be able to prescribe medical cannabis for any condition, meaning that the doors have been flung open to access for patients.
Restrictions still apply, however. Patients will only be able to secure a maximum one month’s supply at a time from prescribers. Patients must also undergo at least one annual medical examination to continue treatment.
Another critical element is that extracts, resins and raw cannabis plants ‘intended for medical use’ are set to be removed from the list of prohibited drugs, a move that has seen Germany’s medical cannabis market explode in size.
There is nuance to this change, though. THC, cannabis’s psychoactive compound, will remain a controlled substance, but will be permitted only when being used in medical or scientific contexts.
Any handling of THC outside these defined uses will continue to fall under drug control legislation. The law goes some way to distinguishing non-psychoactive cannabinoids from THC, but how this will work in practice remains to be seen.
To protect patients from penalties, those prescribed cannabis will receive a “cannabis card” alongside their medicine, allowing them to prove their legal access during checks.
JAZMP to oversee regulation
According to the Slovenia Times, the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) is responsible for managing the licensing process for production permits and permits for the trade of medical cannabis.
MP Sara Žibrat from the Freedom Movement called the law ‘revolutionary’ when it was passed in July, as it seeks to prevent monopolies in the production and cultivation of cannabis for medical purposes from being formed, but enables any company that meets the legal requirements to apply for a license.
Production of medicinal cannabis and related medicines will be subject to rigorous quality requirements, including compliance with GACP, GMP, and European Pharmacopoeia standards, which regulate the quality, manufacture, and testing of medicines.
The aim is to ensure a stable and reliable supply of cannabis via pharmacies, licensed wholesalers, and healthcare providers, while reducing dependence on imports and inconsistent access. The law entered into force on 20 August 2025.
Next steps
The Minister of Health must now set out further technical rules within six months, including requirements for securing cultivation sites, conditions for granting production licences, and mechanisms for monitoring production. During the same period, the ministry must also establish detailed criteria for marketing authorisations and trade supervision.
Regulations on the classification, prescription, and dispensing of human medicines must be harmonised with the new law within 90 days, while JAZMP has 18 months to establish the technical infrastructure for electronic patient and production records.
Industry analysts forecast annual market growth of up to 4%, with Slovenia’s medical cannabis sector projected to reach €55 million by 2029.
The Medical Cannabis Act entered into force 15 days after its publication in the Official Gazette on 20 August 2025, following a parliamentary vote of 50 in favour and 29 against. The measure was strongly backed by the governing left-liberal coalition, while the conservative opposition opposed it.
The post Inside Slovenia’s New ‘Revolutionary’ Medical Cannabis Law appeared first on Business of Cannabis.
Continue reading...
