Contents
Market Overview
Romania represents one of Europe’s most restrictive medical cannabis environments, where legal provisions exist on paper but have not yet been implemented in practice.
The country took its first legislative step in 2013, when it authorised the use of cannabis-derived medicines containing up to 0.2% THC for therapeutic purposes. However, this limited reform excluded full-spectrum cannabis and higher-THC preparations, effectively preventing the establishment of a functional patient access system.
The 2013 legislation also theoretically permitted cultivation, manufacturing, import, and export under licence, but no medical cannabis licences have been granted to date. As a result, there are no domestic producers, authorised products, or patient prescriptions available in Romania.
In 2019, a draft law proposing a broader framework for medical cannabis access — including regulated cultivation and manufacturing — was adopted by parliament but later rejected at the final stage of voting, halting progress toward market establishment.
As of 2025, Romania’s medical cannabis framework remains non-operational, and access to medical cannabis treatment or production remains legally possible but practically impossible.
Regulatory Framework
Romania’s current legal foundation for medical cannabis originates from Law No. 339/2005 on the Legal Regime of Plants, Substances, and Preparations with Narcotic or Psychotropic Effects, as later amended in 2013 to include limited medical use of cannabis derivatives.
The amendment authorised:
- Medical use of cannabis derivatives containing ≤0.2% THC.
- Licensed cultivation, manufacture, import, and export under the supervision of the Ministry of Health and National Agency for Medicines and Medical Devices (ANMDM).
However, due to the absence of secondary legislation defining licensing criteria, cultivation protocols, or product registration requirements, the framework has never been implemented.
The 2019 draft law, which sought to create a structured medical cannabis framework — including physician prescribing rules, cultivation licensing, and patient access mechanisms — was rejected, leaving Romania without a functioning regulatory system.
Consequently, medical cannabis remains a legal abstraction: technically permissible, but without the operational rules to make access possible.vestment and domestic patient access, despite the legal foundation for a medical cannabis system being in place.
Patient Access
Who Can Prescribe?
There are no prescribing pathways currently active in Romania. Physicians are not authorised to prescribe cannabis-based medicines beyond approved pharmaceutical derivatives such as Sativex, which is available on a limited import basis for multiple sclerosis-related spasticity.
Approved Products:
- Sativex (GW Pharmaceuticals): available under special import authorisation; prescribed in rare cases for multiple sclerosis patients.
- No domestically produced or authorised medical cannabis products exist.
Reimbursement:
There is no reimbursement mechanism for cannabis-based treatments. Patients using imported cannabinoid-based pharmaceuticals must pay the full cost privately.r medical cannabis treatment in Cyprus. All costs are borne directly by the patient, and treatment remains rare.ment available for medical cannabis treatment in Greece. All costs are borne out-of-pocket by patients.
Industry and Cultivation
Although the 2013 law theoretically opened the door for licensed cultivation, no medical cannabis cultivation licences have been issued in Romania.
Several attempts by private companies to obtain cultivation permits or to partner with government research institutions have been unsuccessful, primarily due to the absence of enabling regulations.
The Ministry of Health and ANMDM have signalled interest in revisiting the medical cannabis framework, but as of 2025, no new draft legislation or consultation process has been initiated.
As a result, Romania currently lacks:
- Domestic cultivation or manufacturing facilities
- Licensing protocols or inspection regimes
- Market authorisation processes for cannabis-based medicines
Outlook
Romania’s medical cannabis landscape remains frozen at a legislative impasse. Although limited cannabinoid-based medicines are technically available under import exemptions, a full-scale medical cannabis framework does not exist in practice.
For Romania to transition into an active market, it would require:
- Passage of a comprehensive medical cannabis law, building on the 2019 draft framework.
- Establishment of licensing and oversight structures for cultivation and production.
- Implementation of clear clinical prescribing guidelines for physicians.
Until such reforms are enacted, Romania will continue to occupy a symbolic position in the European cannabis landscape — legally permissive in theory, but inactive in practice.
