The cannabis industry is undergoing an unprecedented metamorphosis. What just a few decades ago was a sector operating entirely in the shadows is today one of the most lucrative and regulated areas of pharmaceutical and biotech investment in the world. However, the transition to legality is an extremely demanding process. The barriers to entry are no longer just operational or agricultural, but strictly regulatory. Navigating the intricate administrative mazes of national and international agencies requires impeccable legal expertise.
At S&F Abogados, we have built an elite legal practice designed specifically for corporations, pharmaceutical laboratories, universities and investment funds seeking to operate at the top of this industry. Our approach is not limited to processing documents; we design comprehensive regulatory feasibility strategies that protect multi-million investments and ensure regulatory compliance in one of the most heavily regulated sectors of the global economy.
Obtaining licences to grow cannabis for medical and scientific purposes in Spain
In Spain, the only legal way to handle cannabis plants with THC levels above those permitted for industrial hemp is to obtain express authorisation from the Spanish Agency of Medicines and Medical Devices (AEMPS). This body, which reports to the Ministry of Health, applies extremely restrictive criteria, where documentary and technical excellence is not an option but the minimum standard.
For pharmaceutical companies and universities, obtaining a legal cannabis cultivation licence means passing exhaustive audits. At S&F Abogados, we structure this complex process in several phases to ensure the project succeeds:
- Project design and preliminary audit: Medical cannabis cultivation requires high-security facilities. We work closely with engineers and experts to ensure that the cultivation plans (whether indoor or high-tech greenhouses) comply with the physical security guidelines required by the Spanish State Security Forces (perimeter video surveillance, biometric access control, vaults for storage).
- Preparing the technical and legal dossier: Cannabis research and its subsequent pharmacological development require agronomic reports, seed traceability protocols and a business plan justifying the medical or scientific purpose of the plantation. We draft and supervise every page of the administrative file, making sure it is aligned with AEMPS requirements.
- GACP and EU-GMP certification: For pharmaceutical cannabis production to be commercially viable, it is not enough to grow the plant; it must be processed to medical quality standards. We advise on implementing Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practice (EU-GMP), sine qua non requirements for exporting flower or extracting active ingredients.
Obtaining AEMPS cannabis permits is a corporate milestone that transforms a company’s value. Our legal team acts as direct point of contact with the Agency, responding to requests for information, defending waste destruction protocols and managing authorisations to import genetically stabilised seeds or cuttings. In short, at S&F Abogados we turn the arduous road to a pharmaceutical cannabis licence into a structured, predictable and secure process for investors.
Advice on global cannabis law and international expansion
The medical cannabis market is cross-border by nature. Leading companies do not limit their vision to national borders, but seek to build global supply chains. However, international cannabis legality is a fragmented mosaic in which rules clash with each other. What is freely sold in one country can be a drug trafficking offence punishable by prison in the neighbouring state.
Understanding global cannabis regulation is vital for any corporate strategy. At S&F Abogados, we are proud to be the legal bridge for Spanish companies seeking to break into emerging cannabis markets and for foreign groups wishing to establish their European base of operations in Spain.
Our international practice covers the most strategic markets:
- North America: We analyse the deep asymmetries of cannabis in the United States, where there is an ongoing conflict between state-level legalisation (where multi-billion markets are flourishing) and federal prohibition (which affects banking and trademark registration). We also advise on transactions with Canada, the first G7 country to legalise at federal level and a pioneering market for corporate mergers and acquisitions.
- The European engine: The case of cannabis in Germany is a paradigm. With its recent reforms towards decriminalisation and its robust medical cannabis market (the largest importer in Europe), Germany is positioned as the priority target market. We guide our clients through the complex processes of exporting from Spain to Germany, in compliance with the quotas of the International Narcotics Control Board (INCB).
- Latin America and Asia: We explore opportunities in key exporting jurisdictions such as Colombia and Uruguay, as well as in disruptive Asian markets such as Thailand.
Carrying out an international cannabis expansion requires a deep understanding of comparative cannabis law and international trade (Incoterms, import/export licences and customs regulations). A mistake in customs formalities can mean the detention and incineration of tonnes of extremely valuable raw material.
Having a trusted international cannabis lawyer is your company’s greatest asset. At S&F Abogados, we structure joint ventures, draft international supply contracts (offtake agreements), manage compliance with the 1961 Single Convention on Narcotic Drugs and ensure that foreign capital flows into Spain in compliance with strict anti-money laundering rules. Your vision is global; so is our legal coverage.
Do you need legal advice?
At S&F Abogados we specialise in cannabis law. Find out about our legal services for the cannabis industry, send us an online enquiry or call us on +34 919 532 802.
