Cannabis Regulations

Decriminalization and Social Clubs

In 2015, the personal cultivation and use of cannabis in private spaces was decriminalized in Spain and non-profit cannabis social clubs were allowed to be established in the country. Several regions have tried to regulate cannabis social clubs, including Catalonia which introduced its regulations in 2017, but these regulations were overruled by the Spanish Supreme Court in 2018. This did not stop the clubs’ popularity and some of them continued to operate after switching from a cannabis club license to a private social club license. As a result, cannabis social clubs currently operate in a legal grey area. In early 2024, the City Council in Barcelona stated that it intends to close cannabis social clubs in the city.

Though the 2022 deadline was not met, the Ministry of Health did publish a draft royal decree on 30 September, 2024. The decree proposes the following regulations for Spain’s medical cannabis industry:

• Only specialist doctors will be allowed to prescribe medical cannabis for a limited number of qualifying conditions which include:
  • Spasticity in multiple sclerosis
  • Severe forms of refractory epilepsy
  • Nausea and vomiting due to chemotherapy
  • Refractory chronic pain
• Medical cannabis preparations will be dispensed only from hospital pharmacies, not all pharmacies.
• Medical cannabis will be available in “master formulas” made from extracts and standardized preparations which will comply with regulations established by the AEMPS.
• Medical cannabis in flower form will remain illegal.

Currently, there are only two authorized medical cannabis products in Spain: Sativex and Epidolex.

The AEMPS does grant licenses that allow the cultivation, processing and transportation of medical cannabis for certain activities which include research and export. Initially, the cannabis produced by holders of this license could not be made available to patients in Spain – it could only be exported – but after recent regulatory developments Spanish patients now also have access to medical cannabis.

On October 7, 2025, the Council of Ministers approved the Royal Decree proposed by the Ministry of Health, which regulates the use of standardized master formulas made from standardized cannabis preparations for medicinal use. The Royal Decree established that the authorized clinical uses, specific conditions for preparation, dosage, and prescription, were to be outlined in the monographs published within three months by the AEMPS. Formulations can be prescribed only by specialist physicians in a hospital setting and can only be prepared in authorized hospital pharmacy services in accordance with the Correct Preparation Standards and the technical criteria defined in the National Formulary.

The decree also establishes a public registry, managed by the AEMPS, where all standardized cannabis preparations used to create master formulas will be registered. These products must have a specific composition of THC and CBD as well as comply with manufacturing, traceability, and quality requirements. Preparations that contain more than 0.2% THC must undergo additional inspection.

On January 13, 2026, the AEMPS published the monograph detailing the composition, indications, adverse reactions, and precautions for standardized cannabis preparations that can be prepared in hospital pharmacies for distribution to patients with a prescription from a specialist physician.

The monograph establishes that medical cannabis shall be administered orally, in doses determined by the doctor for each individual patient but daily doses may not exceed 32.4 mg/kg of total THC or 25 mg/kg of body weight of CBD. A standardized cannabis oral preparation is indicated as a last-line treatment when commercially available, authorized, and marketed medications cannot satisfactorily treat a specific patient. Medical cannabis can only be prescribed for chronic pain, spasticity due to multiple sclerosis, severe forms of epilepsy, and nausea and vomiting due to chemotherapy.

Registration of Standardized Cannabis Preparations

Pharmaceutical laboratories responsible for the manufacturing and placement of standardized medical cannabis preparations on the market must submit an application to the AEMPS, requesting the inclusion of their preparations int he AEMPS Register of Standardized Cannabis Preparations.

According to information in the annex of the Royal Decree 903/2025, of October 7, the registration form for standardized cannabis preparations must include the following information and documents:

• Identification of the standardized cannabis preparation by its name, name of the plant substance (according to the European Pharmacopoeia) and definition of the extracts (including physical state and extraction solvents, in case of standardized extracts; THC and CBD content; and the excipients, if any; and the equivalent amount of genuine plant preparation, as a range).
• Name and address of the applicant, name and address of the suppliers of the plant substance, and the name and address of the manufacturers and the places where the different manufacturing phases of the standardized extracts and the standardized cannabis preparation took place.
• The application must be accompanied by the Manufacturing and Import Authorization of the manufacturer of the standardized cannabis preparation as well as the latest Good Manufacturing Practices (GMP) certificate or other proof of GMP compliance.
• The application must be accompanied by the text of the proposed labeling for the primary packaging of the container supplied to hospital pharmacy services.

More detailed information on the chemical and pharmaceutical information that must be provided as part of the registration application dossier can be found in the annex of the Royal Decree.

Cannabis Cultivation License

A license can be obtained from AEMPS in order to be able to cultivate cannabis for:

• Research purposes.
• Production and/or manufacturing of cannabis or cannabis products for medical and scientific purposes.
• Obtaining batches necessary for the validation of the manufacturing process of narcotic active ingredients for medical purposes.

The forms outlining the basic information and documents that must be submitted to apply for a cultivation license can be found on the AEMPS website. The information that must be submitted will include at minimum the following:

• Company’s identification information.
• Description of the purpose of the crops and the activities to be carried out.
• Estimated plots and area to be cultivated.
• Information regarding the starting material.
• Description of the destination and purpose of the cannabis and the products intended to be obtained.
• Information on the authorized manufacturer to whom the harvest will be delivered and who will be responsible for processing it.
• Description of the facilities.
• Description of the safety measures in place.

Cannabis Social Clubs

A cannabis social club establishment in Spain is a non-profit association that allows its members to cultivate cannabis for use by members only. Although Catalonia’s Law 13/2017 regulating cannabis associations is now null and void, the regulations are still considered to be a blueprint in the industry which cannabis social clubs operating in the legally grey market still follow. According to those regulations, the objectives of a cannabis social club must be stated in their statutes and the objectives should include:

• Self-sufficiency and distribution of cannabis among members for private consumption.
• Risk prevention and reduction of harm associated with certain uses of cannabis.
• Quality control of cannabis during production and distribution to members.

Cannabis social club member eligibility criteria include:

• Be 18 years old or above.
• Be a cannabis consumer.
• Have the endorsement of another member. However, the endorsement is not required for individuals who choose to use cannabis for justified therapeutic needs.
• A signed document stating that the individual knows the objectives of the cannabis social club and the duties that they have as its member.

Cannabis social clubs must:

• Not exceed the annual production limit of 150kg of dry flower.
• Obtain an expert technical report on each crop, prepared by an external agronomist with a degree in agricultural engineering or an equivalent degree, that ensures the crop forecasts comply with the agreed consumption forecasts.
• Carry out reviews every six months to adapt production levels to meet the members’ demand, up to a maximum amount of 60g per month per member or, for members aged between 18 and 21, 20g per month per member. However, if consumption is for therapeutic reasons, the amount of cannabis available to members can exceed the limit.
• Store cannabis under hygienic, environmental and safe conditions.

However, it should be noted that since in 2021 the Spanish Supreme Court overturned these regulations governing cannabis social clubs, the clubs now operate in a legal grey area. Moreover, Barcelona’s City Council stated in early 2024 that it plans to close cannabis social clubs in the city. This increases the risk of cannabis social clubs being ordered to close.

Which Countries Allow Cannabis Social Clubs?

Spanish Cannabis Market

Medical Cannabis

The Spanish Ministry of Health must inform the International Narcotics Board of the United Nations every year of the projected cannabis output in Spain. In 2018, only around 400 kg of medical cannabis were produced. In 2021, Spain this increased to around 600 kg. In 2022, Spain’s output of medical cannabis increased by 10 times to 6,000 kg. The rapid increase in output continued in 2023 with 23,425 kg of medical cannabis produced – this is an increase of more than 350%. Over 80% of this amount was exported. In 2024, the AEMPS reported that more than 51,300 kg of medical cannabis was produced by Spanish cultivators. Spain is the eighth largest producer of medical cannabis in the world.

Germany and the UK are the two major markets for Spain’s medical cannabis. According to a consultancy firm Cannamonitor, in 2024, Spain exported a total of 6,466 kg of cannabis flower to the UK and Germany – 4,254 kg to the UK and 2,212 kg to Germany. This is up by 51% from the amount exported in 2023. The firm projects that Spain will export more than 8,000 kg of cannabis to Germany and the UK in 2025.

As of January 2026, according to the AEMPS there were 6 companies authorized to cultivate cannabis for research purposes, 8 companies authorized to cultivated cannabis for the production and/or manufacture of cannabis and its products for medical and scientific purposes, and 3 companies authorized to cultivate cannabis to obtain the batches necessary for the validation of the manufacturing process of narcotic active ingredients for medical purposes.

Meanwhile, Cannamonitor counts around 70 active companies involved in medical cannabis cultivation, processing, research, or pharmaceutical services, and estimates that the sector generated €34 million in revenues in 2023.

Social Clubs and Private Use

Cannabis social clubs in Spain are estimated to serve more than 4 million users and attract around 6.6 to 12.4 million tourist consumers annually. Approximately 70% of Spain’s cannabis social clubs are located in Catalonia.

A 2021 survey found that 90.1% of Spanish citizens are in favor of legalizing medical cannabis and 49.7% would be in favor of legalizing it for recreational use as well.

According to the latest Survey on Alcohol and Other Drugs in Spain, published by the Ministry of Health, in 2024 around 43.7% of the population aged 15-64 have used cannabis at least once in their lifetime, 12.6% (an increase from 10.6% in 2022) have used it in the last 12 months, and 10.5% (an increase from 8.6%) have used it in the last month.

Industry Outlook

Industry experts estimate that a mature domestic medical cannabis market could generate €250 – 400 million annually for Spain’s economy and establish the country as a major European hub for pharmaceutical production.

Calculations from the UAB Faculty of Psychology in 2018 estimate that the total economic potential of a legalized cannabis market in Spain could be equal to €8.5 billion annually.

Spain Medical Cannabis Infographics

How Can Cannabusinessplans Templates Help Start or Grow Your Cannabis Business?

The majority of cannabis licensing programs require the submission of a business plan as part of the application for a cannabis license. Even if it is not mandated by law, a business plan is essential for securing funding and assisting an applicant in understanding how much money it will take to start a cannabis business and how much profit it could make.

A well-structured business plan can make all the difference in helping you demonstrate your proposed cannabis business’ compliance with regulations and its operational viability.

Our complete cannabis business plan template package is everything you need to create a professional business plan for a cannabis business with expert financials and projections. A complete cannabis business plan template package includes:

• Excel Financial Model: change variables and immediately see the impact, break down operational and capital costs, know how much it will take to get into the business and the potential profits.
• Word Business Plan: value proposition, market analysis, marketing strategy, operating plan, organizational structure, financial plan and more.
• PowerPoint Pitch Deck: provide a quick overview of your cannabis business plan.

Cannabis Clones/Seeds Nursery Business Plan Sample, Spain

Hemp/CBD business plan templates are also available at hempcbdbusinessplans.com.

Templates for other countries are available at cannabusinessplans.com.