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San Marino enters medical cannabis market with first licensed producer

San Marino, one of Europe's smallest states, is venturing into the medical cannabis industry with Health Farm, the country's first licensed cultivator. Following a 2021 law permitting pharmaceutical-grade cannabis cultivation, Health Farm has established itself as a first-mover in this tightly regulated market.

The history of cannabis in San Marino © Health Farm srl
Before 2021, all forms of cannabis cultivation - industrial or pharmaceutical - were prohibited in San Marino. Even hemp cultivation in open fields was banned, and CBD was considered a controlled substance. The 2021 legislation marked a significant change, exclusively allowing indoor pharmaceutical cannabis production under strict government supervision, through the Sammarinese Cannabis Control Agency (ASCC). The Health Authority is assigned the function of ASCC which authorizes the manufacturing quotas of the active substance of plant origin based on cannabis and informs the International Narcotics Control Boards (INCB) of the United Nations.

For Ruggero Stacchini, founder of Health Farm, this endeavor is not only a personal dream but also a revival of family tradition. "Fifty years ago, my family grew hemp for ropes, textiles, seeds, and oil," he shares. "That ended under the fascist regime, and since then, cultivation has been illegal. Now, San Marino is progressing, and we're part of that change." As the first company to navigate this new legal landscape, Health Farm has faced numerous regulatory challenges. The operation follows stringent security protocols enforced by national authorities, including local regulatory agency, the Gendarmeria, and private security firms.

Despite these changes, hemp cultivation remains illegal to grow. "Even though San Marino is not part of the European Union, it is close to signing a cooperation agreement with the EU, expected by mid-2025," says Ruggero. "This agreement will integrate San Marino into the European Economic Area alongside Andorra, opening new economic and regulatory opportunities for the country." Hemp is legal in the EU, offering San Marino a potential economic opportunity.

Establishing a cannabis startup in San Marino
Launching a cannabis operation in a new regulatory environment has been challenging. "When the law passed in 2021, I was ready. As a commercial accountant, I had worked with farmers for years, advocating for cannabis cultivation. Still, obtaining a license was a three-year process," Ruggero recalls.

Although several licenses have been issued, Health Farm remains the only company to have fully secured and activated one, as regulatory complexity has deterred many others. Financing has been another significant hurdle, with banks reluctant to support what they consider a high-risk industry. "I had to use all my savings and relied on family and friends for support. Banks view this as an uncertain market - legal frameworks can shift, and cross-border regulations with Italy remain unpredictable."

© Health Farm srl
First harvest
Health Farm's first cultivation cycle began in October 2024, with its inaugural harvest recently trimmed and readied for testing. The company anticipates producing 30 kg of premium-grade cannabis by May 2025. The startup's immediate focus is on establishing pharmaceutical partnerships rather than entering the complex, highly regulated processing sector. "We have authorization for pharmaceutical cannabis, but cultivation is already demanding. Instead of managing the entire production chain, we'd prefer to partner with industry experts," Ruggero explains.

Sustainability and innovation
Operating in a controlled indoor environment, Health Farm uses a vertical farming system with hydroponics. Initially using stone wool substrates, the company is transitioning to coconut coir to support its goal of organic, sustainable production. "Stone wool may be easier to manage, but it generates waste. I aim for minimal environmental impact, both personally and professionally," Ruggero says.

© Health Farm srl
The cultivation facility covers 500 square meters across three levels, with an additional 250 square meters of storage, totaling 750 square meters of operational space. Equipped with 540 LED lights in the flowering chamber and 200 in the nursery, the facility is designed for optimal energy efficiency and plant health. To comply with San Marino's strict pharmaceutical standards, Health Farm has obtained GACP certification and is working on GMP certification. "We had to complete our first cultivation cycles to gather the data needed for GMP licensing, but we're well on our way now."

Organic cultivation and CEA
Health Farm embraces an organic-first philosophy, a rare approach in indoor cannabis cultivation due to its challenges. "Growing organically indoors is tough—conventional methods depend on synthetic nutrients and pesticides. We've chosen natural alternatives like predatory insects and biological pest control," Ruggero explains.

This method, however, comes with trade-offs. Organic treatments require more frequent application and labor-intensive monitoring. "Biological solutions aren't as effective as chemical treatments, so we work three times as hard. But being a first-mover lets us set industry standards instead of following them."

Scaling for the future
Health Farm's current setup allows for a production capacity of up to 50 kg per month, with room for expansion. The company has spent over three years selecting and stabilizing a proprietary high-THC genetic strain, achieving up to 24% THC. While initially focusing on THC-rich cultivars, Health Farm is also exploring balanced THC/CBD strains and potentially pure CBD varieties for future development.

Beyond business growth, Ruggero sees Health Farm as a legacy project. "I'm approaching retirement, and my goal isn't just to run a profitable business—it's to build a sustainable cannabis industry in San Marino. This is about creating an ecosystem where growers, doctors, and patients can collaborate and cooperate."

For more information:© Health Farm srl Health Farm
Via Biagio di Santolino 39 – 47892 Acquaviva RSM
+39 0549960429
info@healthfarmsm.com
healthfarmsm.com