This Regulation establishes requirements for legal entities seeking authorization to handle cannabis for research and educational activities in Slovenia. The Regulation establishes strict protocols for application procedures, physical possession, and operational control. Applicants must submit a detailed scientific proposal detailing the scope, objectives, and methodologies of the research project, alongside credentials for the lead researchers. The Regulation mandates full compliance with Good Laboratory Control Practice and requires entities to maintain dedicated equipment inventories. When cultivation is involved, operators must adhere to Good Agricultural and Collection Practice for medicinal plants as defined by the European Medicines Agency, while ensuring proper identification of the Cannabis sativa L. variety. Strict traceability and physical security measures are required across all stages of production, distribution, and research. Entities must implement continuous tracking from initial seed or planting material through final processing. Applicants are also required to submit a security plan and risk assessment conducted by a licensed security service, including strict personnel access logs for facility entry. Waste management and disposal protocols form a central component of the permitting conditions. Operators must enter into binding agreements with authorized hazardous waste management firms to handle residual materials. The Regulation sets mandatory reporting schedules, requiring operators to submit official destruction records to the Ministry of Health within thirty days of any incineration or disposal event, as well as a comprehensive final report upon project completion.
Slovenia · 2026-01-26