Spain’s medicines agency has published the first official guidance for medical cannabis preparations, confirming that its incoming market will exclude raw cannabis flower in favour of ‘standardised’ oral solutions prepared exclusively in hospital pharmacies.
Since proposals for this more restrictive approach were first made public in February 2024, advocates have challenged its limited scope, arguing it will limit access for thousands of Spaniards who could potentially benefit from medical cannabis treatment.
It comes as its neighbour, France, edges towards the final stages of implementing its own national medical cannabis framework, which also omits raw flower in favour of measured, pharmaceutically focused dosing methods.
As amendments to Europe’s largest medical cannabis market, Germany, are still being hammered out in its parliament, even Drug Commissioner Hendrik Streek suggested that banning flowers could be on the table. While unlikely, it highlights the growing association between medical cannabis flower and ‘pseudo-recreational’ consumption in Germany, also being seen in the UK and Australia.
For Curaleaf International, the first to bring both cannabis pastilles and a CE-certified liquid medical cannabis inhaler to the UK market, this growing shift is more a result of a maturing European market than a rejection of flower itself.
“I don’t see this as a wholesale move away from flower across Europe,” Juan Martinez, CEO of Curaleaf International, told Business of Cannabis. “It’s better understood as how newer frameworks choose to establish themselves.”
“But this does not mean Europe is abandoning flower. In mature markets like Germany and the UK, flower continues to play an important role and will do so for the foreseeable future. It offers fast onset, familiarity, and clinical value for many patients. What we’re seeing is divergence based on regulatory starting points — not a rejection of flower as a medical option.”
What Spain’s formulary reveals
The AEMPS formulary, published in Spain’s official state gazette (BOE) as reference FN/2026/FMT/043, provides the most detailed picture yet of how Spain’s medical cannabis market will operate in practice.
The guidance mandates that all cannabis medicines be dispensed as oral solutions containing standardised THC-dominant (5-150 mg/ml) or CBD-dominant (10-150 mg/ml) preparations, mixed with medium-chain triglycerides (MCT oil) as a carrier. Hospital pharmacists will prepare individualised formulations based on physician prescriptions, with patients receiving glass bottles with dosing mechanisms.
It also specifies maximum daily doses, with adults prescribed up to 32.4mg of THC and 25mg/kg of CBD, while pediatric patients face stricter limits due to concerns about THC’s effects on neurocognitive development.
The four approved indications are consistent with those published in the Royal Decree approved last October, including spasticity due to multiple sclerosis, severe refractory epilepsy, nausea and vomiting caused by chemotherapy, and chronic refractory pain.
Cannabis preparations can only be prescribed ‘as a last resort’ after patients have demonstrated that other authorised medications, including Sativex, have proven ineffective.
While the decree technically permits cannabis flower, it restricts it to sealed, single-use vape cartridges for use with CE-approved medical devices.
The formulary’s publication means Spain is pressing ahead despite two separate Supreme Court appeals filed in December and January by pharmacy associations challenging the hospital-only dispensing model. Those appeals argue the restriction violates existing pharmaceutical law and creates unnecessary barriers to patient access, particularly in rural areas.
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Why are Europe’s emerging markets excluding flower?
Martinez argues that the shift away from flower is a natural evolution in a market focused purely on cannabis as a medicine, helping grease the wheels of integration into existing healthcare models.
“Both France and Spain have launched highly restrictive, hospital-oriented programmes,” he explained. “In that setting, excluding flower is a cautious choice. Flower introduces variability in dosing and administration that can be difficult to reconcile with pharmaceutical norms.
“Standardised formats – oils, capsules, or device-delivered extracts – are easier for clinicians to prescribe, monitor, and integrate into existing clinical workflows.”
Spain’s detailed preparation instructions, standardised cannabinoid concentrations and strict dosage requirements illustrate this focus on pharmaceutical consistency, which is far harder to achieve with dried flower where cannabinoid content can vary from batch to batch and can be influenced by a myriad of factors.
“France, for example, is entering 2026 in a transitional phase from a pilot program to a permanent system,” he continued.
“It’s a tightly controlled environment aligned with pharmaceutical standards, focused on consistency and clinical oversight rather than rapid scale. In that context, regulators tend to prioritise formats that look and behave like conventional medicines: standardised preparations, controlled dosing, and delivery systems that fit within existing hospital and pharmacy models.”
“That naturally drives interest in alternative formats, and it’s where Curaleaf has been leading. We were first to market with cannabis pastilles in the UK, and we’ve introduced Europe’s first CE-certified medical inhalation device, with more form factors coming.”
The ‘perception issue’
While dried flower remains dominant in almost every established medical cannabis market, these products are often lifted directly from recreational markets like Canada and the US, carrying the same names and branding, and with them the lingering stigma.
This association is seeing politicians, medical professionals, and even patients become increasingly uncomfortable with its use as an everyday treatment.
“Perception matters. In many countries, an inhaled cannabis flower still carries the stigma of recreational use. Martinez acknowledged.
“A medical-grade device helps draw a clear line between therapeutic use and that legacy stoner image. When a patient uses a rigorously tested vaporiser or liquid inhaler, it looks and feels more like a legitimate medical treatment.”
Australia, Germany, and the UK all face ongoing challenges managing the perception that their medical cannabis programmes serve as de facto recreational access, particularly given flower’s dominance.
As we’ve discussed previously in coverage of the incoming French market, by opting for a more pharmaceutically focused market from the get-go, this dynamic can be largely avoided.
“This distinction is often what allows medical cannabis frameworks to gain political acceptance in the first place. So yes, the devices solve a clinical need for precision and safety, but they also solve a perception problem by signalling that we’re not just handing out joints to patients. In doing so, they give regulators and clinicians confidence that cannabis can be administered in a ‘doctor-friendly’ and socially acceptable way.
“In early-stage medical programs, regulators are keen to avoid anything that looks recreational. Inhaled flower still carries that association in many countries. Starting with non-flower products allows policymakers to frame these systems as strictly medical and build legitimacy before potentially broadening access.”
With this in mind, however, Martinez suggests that ‘regulatory change doesn’t eliminate underlying patient need, and demand doesn’t disappear by decree’.
As such, these incoming frameworks will ‘test’ whether alternative treatment forms ‘truly meet patient need’, or whether they prove to be merely a ‘marginal solution for a narrow group of patients’.
“In other words, the approach is understandable for a cautious rollout, but its practicality and inclusivity will need to prove themselves over time.”
While patient demand for flower, a familiar and reliable form of treatment, remains dominant in the majority of medical cannabis markets, its becoming increasingly clear that pharmaceutical-grade delivery devices will define the next phase of European market growth.
In the second part of this series, we’ll examine the technical requirements behind CE-certified medical devices, the clinical case for liquid inhalation, and what Curaleaf’s multi-year device investment says about the direction of Europe’s market.
