Spain’s AEMPS registry of standardised cannabis preparations is no longer empty. On 13 July, Curaleaf announced the registration of the country’s first two preparations — CAN-1, THC-dominant, and CAN-2, CBD-dominant — manufactured at its Alicante plant, operated by Medalchemy SL and EU-GMP certified. Spain has moved past the regulatory phase and into actual supply to hospital pharmacies.
What Royal Decree 903/2025 allows
The framework was set by the Council of Ministers on 7 October 2025 with Royal Decree 903/2025, which regulates the preparation and dispensing of standardised magistral formulations made from cannabis preparations. This is not a community-pharmacy model: only specialist physicians may prescribe them, and they are compounded and dispensed exclusively by hospital pharmacy services under individual clinical supervision.
The approved indications are narrow — refractory chronic pain, spasticity associated with multiple sclerosis, refractory epilepsy, and chemotherapy-induced nausea and vomiting — and always in patients who do not respond to conventional treatment. AEMPS completed the scaffolding by adding monograph FN/2026/FMT/043 to the National Formulary, covering an oily oral solution containing THC and/or CBD.
The AEMPS registry is the gateway
The agency opened the registration procedure in January 2026 for laboratories wishing to list their preparations. Applications are filed electronically, require the documentation set out in the decree’s annex, and must evidence manufacturing, traceability and quality requirements; products above 0.2% THC are subject to enhanced oversight. AEMPS has a maximum of six months to issue a resolution.
That detail explains why the numbering matters: CAN-1 and CAN-2 indicate no other company had completed the process first. Medalchemy, the group’s Spanish subsidiary, obtained AEMPS’s first licence to process cannabis for medicinal purposes back in May 2020 — a useful measure of how long it takes to build a position in this market.
Business implications
- The customer is the hospital. The channel is neither retail nor parapharmacy: the counterpart is the hospital pharmacy service and the prescriber is a specialist. Consumer CBD go-to-market playbooks do not apply here.
- The barrier to entry is pharmaceutical. EU-GMP, documented traceability and an AEMPS processing licence. Companies without laboratory-grade infrastructure will need partners who have it.
- Ancillary business opens up. Contract cultivation, extraction, analytical testing, controlled-substance logistics and traceability software now have a domestic customer with defined requirements.
- The clock is tight. With a six-month resolution window, anyone who has not already filed is unlikely to be on the market before 2027.
- Rollout will be uneven. Actual uptake depends on each regional health service and its pharmacy committees, so volume will arrive gradually and territory by territory.
Spain on the European map
The Spanish model is deliberately narrower than Germany’s, and it arrives while France and other markets are also settling their own rules. For the industry, the relevant point is not the initial size of domestic demand — predictably modest — but the fact that there is now certified production on Spanish soil within a framework the rest of the EU can recognise. An EU-GMP plant supplying the domestic market is equally positioned to compete intra-EU, which is where the volume currently sits.
Put differently: the news is not that Spain will sell a lot of medical cannabis in 2026, but that a complete regulatory pathway now exists and has been walked end to end by one company. That turns the Spanish market into something investors, distributors and laboratories can actually assess, rather than filing under “pending”.
From the dossier to the negotiating table
These are exactly the conversations on the agenda at Spannabis B2B Bilbao 2027, the International Cannabis Business Forum taking place on 11 March 2027 at the BEC VIP Room: who manufactures under EU-GMP in Spain, who needs extraction or analytical capacity, and how distribution is structured towards the hospital channel and across Europe.
If your company operates in production, laboratory services, distribution or investment, now is the moment to sit down with the players executing today. Book your ticket or request a B2B table to lock in concrete meetings during the forum.