How to Get a Cannabis License in Italy: Medical & Hemp Permits

Looking to enter Italy’s regulated cannabis market?

Obtaining a cannabis license in Italy requires navigating one of Europe’s most complex regulatory environments. Italy offers two primary commercial pathways for cannabis operators: medical cannabis production (currently a state monopoly) and industrial hemp cultivation under Law 242/2016. Whether you are pursuing pharmaceutical-grade medical cannabis or building a hemp-based business, understanding the licensing framework, compliance requirements, and recent regulatory shifts is essential for success.

This guide breaks down every cannabis license type available in Italy, covers the facility and documentation requirements you will face, and compares Italy’s licensing landscape to five other European markets. For a broader overview of Italian cannabis regulations, see our complete guide to cannabis laws in Italy.

Types of Cannabis Licenses Available in Italy

Understanding every cannabis license in Italy starts with the regulatory structure. Italy’s cannabis licensing framework is managed primarily through the Ministry of Health and its Central Office of Narcotics (Ufficio Centrale Stupefacenti, or UCS). Unlike countries such as Portugal or Germany, where private-sector licenses are well established, Italy’s medical cannabis market remains under tight state control. There are four main pathways.

Medical Cannabis Production License

Medical cannabis production in Italy is currently a state monopoly. The Stabilimento Chimico Farmaceutico Militare (SCFM), a military pharmaceutical facility in Florence, is the sole entity authorized to cultivate cannabis domestically. The SCFM produces approximately 100 kilograms per year, focused on two proprietary strains: FM2 (THC 5-8%, CBD 7.5-12%) and FM1 (THC 13-20%, CBD less than 1%).

A 2022 government tender invited private companies to grow medical cannabis under contract for the SCFM. However, the selection process remains suspended due to legal appeals from participants. Until this process concludes, private medical cannabis cultivation is effectively unavailable. Any future private producer will need EU GMP certification from AIFA (the Italian Medicines Agency), pharmaceutical-grade clean room facilities, comprehensive security infrastructure, and seed-to-sale traceability systems. For the full picture of patient access and prescribing rules, see our guide to medical cannabis requirements in Italy.

Industrial Hemp Cultivation License

Under Law 242/2016, industrial hemp cultivation in Italy does not require a formal license. Instead, growers must register with their local agricultural authority and meet the following conditions:

• Use only seed varieties listed in the EU Common Catalogue of Agricultural Plant Species
• Maintain THC content below 0.2% (with a tolerance threshold of 0.6%, below which no penalties apply)
• Retain seed purchase documentation and tags for a minimum of one year
• Submit to field inspections by agricultural authorities

However, Decree 48/2025, which took effect on April 12, 2025, significantly narrowed permitted uses. Hemp inflorescences (including dried, semi-processed, or shredded forms) and their derivatives (extracts, resins, oils) are now classified as narcotics. Permitted uses are limited to fiber production, seeds, ornamental purposes, energy biomass, and phytoremediation. For details on which hemp business models remain viable, see our guide to hemp cultivation permits in Italy.

Cannabis Research License

A cannabis license in Italy for research purposes is available to universities and public or private research institutions. These entities can obtain authorization from the Ministry of Health (UCS) to cultivate or import cannabis for scientific and research purposes. Notably, organizations engaged exclusively in research, experimentation, or laboratory work are exempt from EU GMP certification. They need only secure regional or state authorization confirming that their premises are suitable. Import permits for research materials are available through the Ministry of Health.

Pharmaceutical Import License

Because domestic production cannot meet demand, Italy relies heavily on imported medical cannabis. The Ministry of Health’s Central Narcotics Office handles import authorizations. Bedrocan, the Dutch company, serves as Italy’s primary long-term supplier. In June 2025, Tilray Medical (through its subsidiary FL Group) became the first private company to receive authorization to import and distribute proprietary branded medical cannabis flower in Italy. Import authorization requires that source facilities hold valid EU GMP certification, and the government sets annual import quotas.

Medical Cannabis Production Requirements

Facility Requirements

Holding a cannabis license in Italy for medical production means meeting stringent EU GMP standards. Any entity eventually authorized must operate in a certified manufacturing facility with clean rooms meeting defined ISO classifications, environmental controls for temperature, humidity, and light, comprehensive security systems including surveillance and controlled access, and segregated processing areas for different production stages. For a detailed breakdown of these standards, see our guide to EU GMP and GACP compliance.

Quality Control and Testing

Italian regulations mandate rigorous batch testing for all medical cannabis products:

• THC and CBD content verification
• Microbiological contamination screening
• Heavy metals analysis
• Pesticide residue testing
• Stability studies over the product’s shelf life

Each batch must be fully documented with certificates of analysis (CoA) before release.

Documentation and Traceability

Seed-to-sale tracking is a core requirement for Italian cannabis operations. Producers must maintain complete batch records, document every stage from cultivation through processing and distribution, and submit annual compliance reports to the Ministry of Health. This level of documentation is where many operators struggle, particularly when scaling across multiple facilities or preparing for EU GMP audits.

GrowerIQ helps cannabis cultivators and processors automate batch record management, maintain EU GMP documentation standards, and generate compliance reports. For operations entering the Italian market, having a digital seed-to-sale platform in place from day one reduces audit preparation time and strengthens your regulatory position.

Industrial Hemp Business Requirements

Registration Process

While a cannabis license in Italy for hemp does not require formal approval, starting a hemp business involves a notification-based process:

1. Notify your local agricultural authority of your intent to cultivate
2. Purchase certified seeds from EU Common Catalogue approved varieties
3. Retain seed labels and purchase receipts for at least one year
4. Prepare for potential field inspections by authorities

Post-2025 Business Models

Following Decree 48/2025, hemp operators in Italy must focus on business models that do not involve flower harvesting or CBD extraction from inflorescences. Viable options include:

• Fiber production for textiles, insulation, and building materials
• Hemp seed products including food-grade seeds and cold-pressed oil
• Biomass for energy and industrial applications
• Seed production (processing inflorescences for seed is still permitted)

For details on how the April 2025 restrictions affect CBD products specifically, see our guide to CBD extraction regulations in Italy.

Export Considerations

Italy’s position within the EU single market provides an advantage for hemp fiber and seed products, which move freely across member states. However, Decree 48/2025 has effectively halted cross-border trade in hemp flower and CBD derivatives originating from Italy. Export of medical cannabis to third countries requires specific permits from the Ministry of Health, and all shipments must include a Certificate of Analysis.

For operators exploring licensing in neighboring markets, see our guides to cannabis licensing in Portugal, cannabis licensing in Germany, and cannabis licensing in Spain.

How Italy Compares to Other European Cannabis License Markets

Italy’s cannabis licensing environment stands out for its restrictive medical production monopoly and recent tightening of hemp regulations. Operators considering a cannabis license in Italy should understand how it compares to neighboring frameworks. The following table evaluates Italy against five other European markets across key dimensions.

For operators evaluating where to establish European cannabis operations, Italy currently presents the highest barriers to entry for medical production. However, the pending resolution of the 2022 private production tender and the EU Court of Justice ruling on Decree 48/2025 could substantially change the landscape. Countries like Portugal and the Czech Republic offer more accessible entry points today, while Malta provides a high-cost but comprehensive pharmaceutical framework.

Compliance Technology for Italian Cannabis Operations

Whether you hold a cannabis license in Italy for hemp cultivation or are positioning for future medical production, compliance technology is not optional in this regulatory environment. The Ministry of Health requires detailed traceability records, and EU GMP audits demand complete documentation of every batch, every process, and every quality control test.

Key compliance needs for Italian operators include:

• Seed-to-sale tracking from planting through harvest, processing, and distribution
• EU GMP documentation including SOPs, deviation reports, and CAPA (Corrective and Preventive Action) logs
• Batch record management with full audit trails for each production lot
• Regulatory reporting tools that generate Ministry of Health compliant reports
• Multi-facility management for operations spanning cultivation, processing, and distribution

GrowerIQ’s seed-to-sale platform is built for exactly this environment. Our software helps European cannabis producers maintain continuous compliance through automated batch tracking, integrated quality management, and export-ready documentation. Whether you are preparing for an AIFA inspection or scaling across multiple EU markets, GrowerIQ ensures your records meet the standard.

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