Medical Cannabis Legalization

Medical cannabis use was legalized in Greece in June 2017 – the sixth EU country to do so – and on 2 March 2018, the Greek government introduced Law 4523/2018 and announced plans to cultivate cannabis for domestic consumption and export.

In May 2018, the Joint Ministerial Decree No. 51483/700/Φ.15 outlined the terms and conditions for the cultivation and processing of medicinal cannabis. Companies must be vertically integrated and licenses are nontransferable.

According to the law passed in 2018, the license for the cultivation and processing of medical cannabis in Greece has two main stages:

• 1st stage: obtaining the first license which is called installation approval, which is the license that allows the medical cannabis investor to start building the facility.
• 2nd stage: as soon as the facility is designed and built, it is necessary to get the operation approval which certifies that everything is done properly and according to the EU-GMP standards.

In May 2021, the Greek Parliament voted in favor of Law 4801/2021 to legalize production, export and distribution of final products of pharmaceutical cannabis of the species Cannabis Sativa containing over 0.2% Tetrahydrocannabinol (THC). The exported medical cannabis product must have the authorization necessary to be marketed only in the country where it is being imported – no marketing authorization from Greece is required. In November 2021, the Greek government introduced a ban on the importation of cannabis products.

In March 2022, the terms and conditions for the license to export medical cannabis products in the form of dried flower were stated through the Joint Ministerial Decree No. 27462/2022.

In Greece, patients can be prescribed medical cannabis for:

• Prevention and treatment of severe nausea or vomiting caused by chemotherapy, radiotherapy and combination therapy for HIV or hepatitis C.
• Treatment of chronic pain, related to cancer or diseases of the central or peripheral nervous system, such as neuropathic pain caused by: nerve damage, “phantom limb”, trigeminal neuralgia, postherpetic neuralgia.
• Treating spasticity associated with multiple sclerosis or spinal cord injuries.
• Use as an orexigenic in palliative care of patients undergoing treatments for cancer or acquired immunodeficiency (AIDS).

Medical cannabis can be prescribed by anesthesiologists, neurologists, pathologists – oncologists, pathologists – infectious disease specialists, and rheumatologists.

To be able to use medical cannabis, patients must first obtain a prescription through the electronic platform from their doctor. The patients can then pick up the medical cannabis preparation prescribed by their doctor from a pharmacy.

A special marketing authorization must be obtained from the National Medicines Agency (EOF) in order to be able to make a medical cannabis product available for patients in Greece.

How to Start a Cannabis Business in Greece?

Those wishing to cultivate, transport, process, supply or export medical cannabis and final medicinal cannabis products with a THC content of more than 0.2% must obtain a license.

Installation approval application fee: €10,000

Operation approval application fee: €10,000

If the applicant proceeds with a single approval for installation and operation, then a fee of €15,000 is required.

Licensing Process:

1. A completed questionnaire found in Annex I of the Joint Ministerial Decree No. 27462/2022 must be submitted to the Business Licensing and Business Parks Department of the General Secretariat for Industry (GGB Licensing Department).
2. The GGB Licensing Department shall provide the applicant with a response within 5 working days, stating the required supporting documents for the installation approval and the operation approval, respectively.
3. The applicant submits the supporting documents for the installation approval in six copies: one in printed form and the remaining five in digital form.
4. The Licensing Directorate of the General Secretariat of the Hellenic Republic transmits to the competent Services of the Ministry of Rural Development and Food, the Ministry of Health/EOF and the Hellenic Police, a digital copy accompanied by a copy of the submitted questionnaire. Within 30 days, the EOF will issue an opinion regarding the granting of the establishment approval.
5. Within 30 days from the submission of a complete file, the installation approval is granted by a joint decision of the competent authorities of the bodies of the Ministries of Development and Investments, Health and Rural Development and Food. This approval is valid for 5 years.
6. Within 15 days of granting the installation approval, the Licensing Department of the General Secretariat of the Hellenic Republic shall conduct an on-site inspection to confirm the suitability of the space and the correctness of the questionnaire.
7. The applicant submits the supporting documents for the operation approval must be submitted in six copies: one in printed form and the remaining five in digital form.
8. The Licensing Department of the General Secretariat of the Hellenic Republic of the Hellenic Republic transmits a digital copy to the competent Services of the Ministry of Rural Development and Food, the Ministry of Health/EOF and the Hellenic Police. Within 30 days, the EOF will issue an opinion regarding the granting of the establishment approval.
9. Within 30 days from the submission of a complete file, the operation approval is granted by the decision of the Ministers of Economy and Development, Health and Rural Development and Food. The approval is valid for 10 years.
10. Within 2 months of the issuance of the operation approval, the Licensing Department of the General Secretariat of the Hellenic Republic shall conduct an on-site inspection to confirm that the conditions for granting the operation approval have been satisfied.

Supporting documentation to be submitted:

Some additional documentation may be required – these can be found on the official website of the National Registry of Administrative Procedures.

The Licensing Department of the General Secretariat of the Hellenic Republic shall conduct on-site inspections at least annually to check that the conditions for the installation and operation approval are being satisfied.

By 31 December of each year, the licensee must submit updated supporting documentation for the installation and operation approval.

A special permit is required for the installation of greenhouses and greenhouse-type chambers for medicinal cannabis. The process to obtain it is outlined here.

No extra license is required for the import or export of propagating material of cannabis varieties with a THC content of more than 0.2%.

There are also production licenses available exclusively for the export of final medicinal cannabis products or finished medicinal cannabis products in the form of dried flower specifically.

The applicant must also meet the safety and production capacity requirements of the processing units producing medicinal cannabis products stated in Article 15 of the Ministerial Law No. 4801/2021.

In order to be able to sell a final medicinal cannabis product through pharmacies in Greece, a marketing authorization is required from the EOF. This is necessary both for a product produced in Greece and for a product imported into Greece. The marketing authorization is valid for 3 years.

An application for a marketing authorization shall be accompanied by the following information and documents:

• Name or company name and residential address or registered office of the applicant.
• Name of the final medicinal cannabis product.
• Qualitative and quantitative composition of the final medicinal cannabis product.
• Methods and specifications for raw material quality control and validation of the control methods.
• Development studies of the final medicinal cannabis product.
• Production process, necessary intermediate quality controls during production, critical stages of the production process and validation of the production process in compliance with guidelines of good manufacturing for medicinal products intended for human use as defined by Greek legislation.
• Methods and specifications for quality control of the final product, validation of the control methods, results of analysis of test batches.
• Composition, type, characteristics of the immediate container.
• Stability studies of the final product.
• Therapeutic indications, contraindications and adverse reactions.
• Dosage, pharmaceutical form, method and route of administration and expected shelf life of the product.
• Justification for any precautionary and safety measures to be taken for the storage of the product, its administration to patients and the disposal of residues, as well as the potential risks that the medicinal product presents for the environment.
• A summary of the applicant’s adverse reaction monitoring system which must include:
  • Proof that the applicant has a qualified person responsible for the monitoring of adverse reactions.
  • Contact details of the qualified person.
• Risk management plan.
• Summary of the product characteristics including:
  • Maximum quantitative composition limit in THC.
  • Pharmaceutical form.
  • Pharmaceutical properties.
• A mock-up of the outer packaging and primary packaging of the medicinal product.

At least 9 months prior to the expiration date of the marketing authorization, the holder of the marketing authorization must submit all the data of the adverse reaction monitoring system file.

Cannabis Market in Greece

With its favorable climate and geographical location, Greece can play a leading role in the development of the medical cannabis industry. According to a 2020 study, a medical cannabis operation that owns a 1 hectare greenhouse and cultivates and processes medical cannabis in Greece would earn net profit of €3.5 million in the first year of operations and around €7.07 million annually from the second to the tenth year.

From 140 approved facilities to date, only 4 have received operating approval and only one of them has received authorization to place its products on the market.

In February 2024, the first locally produced finished medicinal cannabis products – preparations of dried cannabis flower – became available to patients with a prescription. It is estimated that one of the new medicines has been administered to around 4,000 patients in 2024 and another 4,000 patients already in the first quarter of 2025.

In December 2024, Tikun Europe made the first export of finished medical cannabis products from Greece to Switzerland. Tikun continued to expand its export activity in 2025, exporting medicinal cannabis to the UK and German markets in May 2025.

According to the European Cannabis Report, by 2028 Greece’s industrial and pharmaceutical cannabis industry could inject some €2 billion into the local economy.