Regulatory Affairs Medical Cannabis in Spain
Specialized legal advice for medical cannabis projects in Spain. I assist you with obtaining AEMPS licenses, GMP/GACP regulatory compliance, and coordination with the national and international pharmaceutical industry.
Legal Framework
Medical cannabis in Spain: an expanding market
Spain has established itself as one of the leading European producers of medical cannabis, with an evolving regulatory framework that offers opportunities for prepared companies.
International Recognition
In December 2020, the UN removed cannabis from Schedule IV of substances without medical value, officially recognizing its therapeutic potential and opening the door to regulations worldwide.
Royal Decree 903/2025
Regulates the use of standardized master formulas of cannabis preparations for refractory chronic pain, severe epilepsy, and spasticity due to multiple sclerosis.
AEMPS as authority
The Spanish Agency of Medicines and Medical Devices (AEMPS) is the sole competent body for authorizing the cultivation, production, and manufacture of cannabis for medical and scientific purposes.
The medical cannabis market in Spain requires specialized legal advice from the initial stages of a project. Regulatory complexity, pharmaceutical standards, and AEMPS inspections make it essential to have professionals with real experience in the sector.
Who do we help?
Profiles seeking advice on medical cannabis
Investors
Funds and individuals interested in the medical cannabis market who need legal due diligence and regulatory viability analysis.
Cannabis Cultivators
Agricultural companies wishing to enter the medical sector through AEMPS licenses for cultivation for medical or scientific purposes.
Industry Experts
Pharmaceutical laboratories, active ingredient manufacturers, and distributors requiring support in specialized regulatory matters.
Entrepreneurs
New projects needing guidance from scratch: corporate structure, technical requirements, legal viability, and regulatory roadmap.
Included Services
What is included in Medical Cannabis Regulatory Affairs advice
Comprehensive legal support throughout all project phases, from initial viability analysis to obtaining and maintaining licenses.
AEMPS Licenses
Complete advice on the application process for authorization before the Spanish Agency of Medicines and Medical Devices.
- Cultivation license for medical purposes
- Cultivation license for research purposes
- Production and manufacturing authorization
- Registration in the Standardized Preparations Register
- License renewal and maintenance
GMP/GACP Regulatory Compliance
Legal guidance to comply with European standards for Good Manufacturing Practices and Good Agricultural and Collection Practices.
- Analysis of applicable GMP/GACP requirements
- Preparation for AEMPS inspections
- Coordination with technical and pharmaceutical consultants
- Review of Quality System documentation
- Support for post-inspection action plans
International Coordination
Management of legal aspects for import, export, and collaboration operations with international pharmaceutical companies.
- Contracts with pharmaceutical distributors
- Export authorizations
- Coordination with regulators from other countries
- Due diligence for cross-border operations
- Network of international contacts in the sector
Legal Viability Analysis
Initial project evaluation to determine legal requirements, risks, and regulatory roadmap before making significant investments.
- Legal viability study of the project
- Identification of requirements and entry barriers
- Analysis of optimal corporate structure
- Personalized regulatory roadmap
- Estimation of legal timelines and costs
Methodology
How I approach medical cannabis projects
Initial consultation and project analysis
Complete evaluation of your project: type of activity (cultivation, production, research), current business structure, available resources, and short- and long-term objectives. I identify specific legal requirements and main entry barriers.
Legal viability study
Detailed analysis of applicable regulations, technical requirements (GMP/GACP), and AEMPS procedures. I provide a report with the regulatory roadmap, estimated timelines, approximate costs, and identified risks.
Application preparation
Drafting and review of all necessary documentation: technical reports, project justification, corporate documentation, and security plans. Coordination with technical consultants (pharmacists, engineers, agronomists) for specialized parts.
Processing and follow-up
Submission of the application to the AEMPS and management of the entire procedure: response to requests for rectification, preparation for inspections, and coordination with the Agency’s technical staff until authorization is obtained.
Ongoing support
Once the license is obtained, I advise you on continuous compliance with obligations: renewals, communications to the AEMPS, activity expansions, contracts with pharmaceutical distributors, and export operations.
Investment
Customized budget according to your company’s needs
Personalized budget
Adapted to the scope and complexity of your project
- Initial project evaluation consultation
- Personalized legal viability report
- Detailed budget by project phases
- No obligation until budget acceptance
- Transparent fees with no surprises
Each medical cannabis project has unique requirements. The budget is prepared after evaluating the full scope: license type, current project status, necessary services, and timelines.
Your Lawyer
Over 10 years advising the cannabis industry in Spain
The medical cannabis market requires deep knowledge of both pharmaceutical regulations and the cannabis sector. My experience combining both worlds allows me to offer specialized and dedicated advice that goes beyond purely legal aspects.
Lecturer at the University of Barcelona Master in Cannabis from CannabisHub
+10 years in the sector Real experience in cannabis projects
International contacts Network of industry professionals in Europe and internationally
Specialized training Specialist in Regulatory Affairs, Compliance, and Criminal Law
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View serviceFrequently Asked Questions
Questions about Medical Cannabis Regulatory Affairs
Yes, but only with express authorization from the AEMPS (Spanish Agency of Medicines and Medical Devices). The license is granted solely for medical or scientific purposes, not for recreational use. Strict technical, safety, and traceability requirements must be met, in addition to demonstrating that an authorized pharmaceutical client exists for the product.
The complete process usually takes between 12 and 24 months from the submission of the application, depending on the project’s complexity, the Agency’s rectification requirements, and the applicant’s prior preparation. Good technical and legal preparation can significantly reduce timelines.
The applicant company must be prepared to operate in a pharmaceutical environment. This means complying with EU standards for Good Manufacturing Practices (GMP), Good Agricultural and Collection Practices (GACP), and legislation on psychotropic substances and narcotics. It is also necessary to have adequate facilities, qualified personnel, and a letter of intent from an authorized pharmaceutical client.
A research license allows cannabis cultivation exclusively for scientific projects or clinical trials, without commercialization. A production license authorizes the cultivation, production, and manufacture of cannabis and its derivatives for medical purposes, including the possibility of export to authorized pharmaceutical distributors.
Yes, companies with an AEMPS license can export medical cannabis and its derivatives to countries where a legal framework permits it. Specific export authorizations must be obtained, and the requirements of the destination country must be met. Spain has consolidated its position as one of the main European producers for export.
This Royal Decree regulates the use of standardized master formulas prepared from standardized cannabis preparations for medical use. It allows specialist doctors to prescribe these preparations for indications such as refractory chronic pain, severe epilepsy, or spasticity due to multiple sclerosis. The preparations must be registered with the AEMPS and dispensed in hospital pharmacy services.
Contact
Do you have a medical cannabis project?
Tell us the details of your project, and we will contact you for an initial consultation to assess legal viability and next steps.