The cannabis sector and its derivatives have undergone a radical transformation in recent years, moving from the margins to become one of the markets with the greatest economic potential worldwide. However, operating in Spain and the European Union means navigating a highly restrictive and constantly evolving regulatory maze. The barrier to entry is not commercial demand, but technical and legal complexity. For a project to be viable and secure, specialist legal support is not an expense but the most important initial investment.
At S&F Abogados, we know that success in this sector takes far more than good intentions. It requires meticulous corporate planning and in-depth knowledge of regulators such as the Spanish Agency of Medicines and Medical Devices (AEMPS) and the European Food Safety Authority (EFSA). Our firm is the ideal strategic partner for entrepreneurs, farmers and investment funds seeking to capitalise on this boom with complete legal certainty.
Legal advice for medical and industrial cannabis companies
Cannabis legality in Spain rests on a fundamental distinction that every operator must understand before starting any activity: the legal difference between psychoactive cannabis (for medical or research purposes) and industrial hemp (grown for fibre, grain or seeds). Confusing the two regimes can lead to serious criminal liability and frozen capital.
For those looking to set up a medical cannabis company, the path is demanding. Producing flowers with high THC levels requires prior authorisations and licences issued by the AEMPS. At S&F Abogados, we handle the processing of these complex licences, preparing technical dossiers and security plans and ensuring that facilities comply with GACP (Good Agricultural and Collection Practices) and GMP (Good Manufacturing Practice) standards.
On the other hand, industrial hemp regulation allows varieties listed in the EU Common Catalogue to be grown, as long as the THC level does not exceed the legal limits (currently 0.3% under the EU CAP). However, in Spain obtaining CBD from hemp flower remains subject to interpretative disputes with the authorities, which often require extraction to take place outside the country or under strict health authorisations.
Our advice covers the entire value chain:
- Cannabis corporate law: We set up companies adapted to the particularities of the sector, draft shareholders’ agreements to protect your cannabis investment and design efficient corporate structures.
- International trade: Cannabis imports and cannabis exports (whether biomass, extracts or finished products) require import licences, phytosanitary certificates and specific customs clearance. We prevent customs hold-ups that could ruin the raw material.
- Business development: We advise on the creation, formulation and distribution of cannabis products, ensuring that every contract with suppliers, extraction laboratories and distributors protects your company’s interests.
Regulatory compliance for cannabidiol (CBD) products
The real driver of growth for the general public today is the CBD industry. However, this boom has been accompanied by tight controls. Selling products derived from non-psychoactive hemp requires strict compliance with CBD regulations, which vary drastically depending on the final classification of the product (cosmetic, food, vaping or external use).
To ensure that selling CBD in Spain goes smoothly, it is essential to make sure we are dealing with legal CBD products. This means, first of all, certifying through accredited laboratories (ISO 17025) that the final product has no narcotic effects and strictly respects THC thresholds.
The great challenge our clients face is product classification:
- Cosmetics: CBD oil regulation in Spain, as required by the AEMPS, largely restricts these products to topical use. At S&F Abogados, we register your products on the European Cosmetic Products Notification Portal (CPNP) and review the Product Information File (PIF), ensuring full health compliance for cannabis products .
- Food (Novel Food): EU CBD rules state that cannabidiol is considered a “novel food”. Therefore, selling it as a food supplement or ingredient in food is prohibited in the EU unless it has express EFSA authorisation. We design strategies for marketing CBD that avoid sanctions from consumer or health authorities, advising on what can and cannot be sold within this regulatory framework.
Finally, we pay special attention to CBD labelling and marketing campaigns. The authorities are relentless with companies that attribute therapeutic, medical or curative properties to products that are not approved medicines. We audit your packaging, website and promotional materials to ensure that advertising claims comply with current law, avoiding sanction proceedings for misleading advertising or health infringements.
The cannabis and CBD market rewards pioneers, but only those who operate under the umbrella of maximum legal certainty. At S&F Abogados, we turn regulatory complexity into your main competitive advantage.
Do you need legal advice?
At S&F Abogados we specialise in cannabis law. Find out about our services for cannabis businesses, send us an online enquiry or call us on +34 919 532 802.
