Cannabis Cultivation Portugal (Legalities, License, & Thriving Companies)

Learn licensing regulations and grow cannabis legally in Portugal

For years, Portugal has been known for its progressive stance on drug decriminalization. Recently, the country has made headlines for its regulated cannabis cultivation sector. The emergence of legal cannabis cultivation in Portugal has opened the door to many opportunities for both growers and entrepreneurs. As interest in cannabis cultivation in Portugal increases, inquiries regarding the legal framework, eligibility for obtaining a cultivation license, and the necessary requirements become more frequent. This blog aims to provide comprehensive information to assist individuals in navigating the complexities of establishing a cannabis plantation in Portugal.

Grower IQ’s cannabis production software can help you cultivate cannabis in compliance with Portuguese regulations. This platform lets you stay organized, easily track your progress, create detailed reports, and maintain meticulous records to help you achieve your goals.

Is Cannabis Allowed In Portugal? What The Current Laws Say

Portugal stands out as a European leader in cannabis reform policies. The country took a significant step in changing its cannabis laws in 2001 when it decriminalized personal use of the plant. This meant that while cannabis was still illegal, punishments were replaced with treatment and education. 

The shift in policy reduced the number of drug users in Portugal. In 2018, the country further expanded its cannabis laws to legalize medical cannabis. The new framework allows for the:

• Regulated production
• Importation
• Sale of cannabis products for patients with a doctor’s prescription

Exploring the Role of Infarmed I.P.

All cannabis-related activities in Portugal require licensing from Infarmed I.P., the agency under the Portuguese Health Ministry responsible for regulating:

• Medicines 
• Health products

Infarmed I.P. ensures that all cannabis cultivation and production adhere to stringent public health standards.

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Cannabis Cultivation Portugal (How To Get A License)

Getting a cannabis license in Portugal is no easy task. Infarmed I.P. is the primary national authority in Portugal responsible for establishing conditions and granting authorizations for a wide range of cannabis-related activities. These activities include:

• Cultivation
• Production
• Manufacturing
• Employment
• Trade
• Distribution
• Import
• Export
• Transit
• Transport
• Possession

The scope of Infarmed I.P.’s authority covers plants, substances, and preparations listed in Tables I to IV of Decree-Law No. 15/93, within the limits defined by the country’s needs, prioritizing medical, veterinary, scientific, and educational interests as outlined in the same decree and Regulatory Decree No. 61/94.

Holding Your Hand Through The Licensing Process

Ordinance 83/2021, issued on April 15, 2021, was introduced to clarify various steps in the licensing process for cannabis-related activities. It also specified the security requirements that must be met, including the necessity for a police inspection to ensure compliance. 

This ordinance helps streamline the licensing process, making it clearer for applicants to understand the requirements.

Going Digital: Electronic Submissions and Licensing Portal

Applications for authorizations to engage in activities such as:

• Cultivation
• Manufacturing
• Wholesale trade
• Import
• Export
• Transport

Electronic Submission

Circulation of cannabis-based medicines and substances must be submitted electronically. The Pedidos de licenciamento page provides access to the necessary forms and drafts for these licensing requests. Applicants can use the Portal Licenciamento to:

• Submit and monitor their applications
• Make payments
• Respond to requests for additional information
• Receive decisions, authorizations, permits, or certificates

This portal is essential for entities involved in the wholesale distribution of drugs, medical devices, and active substances, as well as those in the manufacturing and drug intermediation activities.

The Importance of Complying With Good Practices

All licenses granted by Infarmed I.P. require strict adherence to the following:

• Good Agricultural Practices (GAP)
• Good Manufacturing Practices (GMP)
• Good Distribution Practices (GDP)

An authorization and a certificate of Good Practices from a community model are publicly available on the European EudraGMDP database for manufacturing and wholesale activities. This ensures that licensed activities meet the high standards required for quality and safety.

Everything You Need To Know About Import, Export, And Transit Operations

Each import, export, and transit operation involving cannabis requires an Official Import, Export, or Transit Certificate. Applicants must submit the appropriate application and fee payment guide for these operations. This process ensures that all international movements of cannabis products are:

• Properly documented 
• Regulated

Annual EUA Application Requirement

Applicants must submit an annual Emergency Use Authorization (EUA) application for medicinal products with well-recognized clinical benefits in September. This requirement ensures that such products are available for medical use under regulated conditions.

The Licensing System In Portugal

There is a pre-license/provisional license system. Licenses may be obtained for: 

• Cultivation – €3,000.
• Manufacture – €3,000
• Wholesale trade – €1,000
• Import – €1,200
• Export – €1,200
• Transit – €1,000

The license holder is not authorized to use these medicines or substances themselves.

Is Cannabis Oil Legal In Portugal?

Cannabis oil and CBD (cannabidiol) are legal in Portugal under certain conditions. Regulatory grey areas surround the use of CBD. Since 2001, possession and consumption of cannabis have been decriminalized in Portugal. In 2018, the government made changes to the law allowing for the medical use of cannabis. 

Under these laws, patients can obtain cannabis and cannabis oil through prescriptions and licensed pharmacies. The cultivation of cannabis for medical purposes is also allowed, but it is strictly regulated. Only licensed producers can grow cannabis, and they must follow good manufacturing practices and other strict regulations. 

How Many Cannabis Licenses Are There in Portugal?

Portugal has emerged as a leading global producer of medicinal cannabis. As of 2023, 42 licensed companies were actively engaged in cannabis-related activities, an increase from 34 in 2022. This 23.5% growth reflects the increasing momentum in the country’s medicinal cannabis sector.

The number of entities involved could rise significantly as 150 other companies navigate the licensing process. Infarmed, the National Authority for Medicines and Health Products plays a crucial role in issuing these licenses. In 2023, Infarmed granted 76 new authorizations for various activities, including:

• Cultivation
• Manufacturing
• Import
• Export
• Distribution of cannabis

Pending Requests

There are 265 pending requests in the post-decision or suitability for inspection phases, covering different areas such as:

• 98 requests for cultivation inspections
• 38 requests for manufacturing
• 115 requests for import/export
• 14 requests for wholesale distribution

Here’s a breakdown of the existing licenses:

• 24 companies hold cultivation licenses
• 5 companies are licensed for manufacturing and preparation
• 12 companies have wholesale trade licenses
• 32 companies are authorized for import and export

EU-GMP Certification

17 companies have earned EU-GMP (Good Manufacturing Practices) certification, indicating compliance with high standards in the production of medicinal cannabis. While Portugal has exported over 5.4 tons of cannabis by August 2023, primarily to markets like Germany, Poland, and Australia, domestic prescriptions remain low.

Domestic Prescriptions

Only 524 packages of the available Tilray Flor Seca with 18% THC have been prescribed in Portugal. The growth in licenses and exports positions Portugal as a significant player in the global medicinal cannabis industry. 

The ongoing licensing process suggests that even more companies could enter the market soon, contributing to the sector’s continued expansion.

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List Of Licensed Cannabis Companies Portugal

Cannabis cultivation in Portugal is a new and dynamic industry. As of October 2023, INFARMED, the National Authority of Medicines and Health Products, has licensed 32 companies to produce and manufacture cannabis for medicinal use. 

The first cannabis plants were cultivated in Portugal in 2018, and the first licenses were issued by INFARMED to companies in 2019.  The licensed companies are now working to create a robust network for the production and distribution of medical cannabis products both for the domestic market and for export.

Companies Licensed To Cultivate Controlled Substances – Cannabis

1. Key Leaves Ltd.
2. Qanali Ltd.
3. MHI Cultivo Medicinal SA (Medicane)
4. SMC Therapeutic Health Center Production, Ltd.
5. RPK Biopharma, Unipessoal, Lda.
6. Terra Verde, Ltd.
7. Tilray Portugal, Unipessoal, Lda.
8. Sabores Púrpura, Lda.
9. Sun Light Greens SA
10. Grovida Ltd.
11. Pure Healing Ltd.
12. Canna Forest, Ltd.
13. 1Agrivabe Produção Agrícola Lda.
14. Cannexpor Pharma Lda.
15. Cannprisma Pharma, Lda.
16. Weez Garden, Unipessoal Lda.
17. Sociedade Agrícola Monte das Barrocas, Lda.
18. Symtomax Unipessoal Lda.
19. Agrovete, SA
20. Galaxiavertical – Unipessoal Lda.
21. Belvedere Pharma SA
22. GBE Pharma Unipessoal Lda.
23. Canneurox Portugal Unipessoal SA (Avextra)
24. Schroll Flavors Produção e Comercialização de Produtos Agrícolas Unipessoal Lda.

Companies Licensed To Manufacture Preparations And Substances Based On The Cannabis Plant

1. Infosaúde – Institute for Training and Innovation in Health, SA
2. Somaí Pharmaceutical, Unipessoal Lda.
3. Portocanna, SA
4. QPLab Pharma Services, Lda.
5. RPK Biopharma, Unipessoal Lda.
6. Agrivabe Produção Agrícola Lda.
7. Labialfarma Laboratory of Pharmaceuticals and Nutraceuticals, SA
8. Iberfar Indústria Farmacêutica, SA
9. Cannprisma Pharma, Lda.
10. MHI Cultivo Medicinal, SA (Medicane)
11. Sociedade Agrícola Monte das Barrocas, Lda.
12. Bluestabil – Stability Studies Services, Lda
13. Blossom Genetics Unipessoal Lda.
14. ISQ – Institute of Welding and Quality
15. Technophage, Research and Development in Biotechnology SA
16. Tilray Portugal, Unipessoal, Lda.

Companies Licensed For Wholesale Trade In Preparations And Substances Based On The Cannabis Plant

1. Canna Forest Lda.
2. Smart Nature, Ltd.
3. Sabores Púrpura, Lda.
4. Alliance Healthcare SA
5. Logistics, Transport, Forwarding and Pharma, Unipessoal, Lda.
6. Jazz Pharmaceuticals France – Branch in Portugal
7. Ferraz Lynce Especialidades Farmacêuticas, SA
8. Plural – Pharmaceutical Cooperative, CRL
9. Alloga Logifarma, SA
10. Noidecs, Unipessoal, Lda.
11. Galaxiavertical, SA

Companies Licensed To Import Preparations And Substances Based On The Cannabis Plan

1. Key Leaves, Ltd.
2. MHI Cultivo Medicinal, SA (Medicane)
3. Smart Nature, Ltd.
4. Qanali Ltd.
5. Portocanna, SA
6. SMC Therapeutic Health Center Production, Lda.
7. Blossom Genetics Unipessoal Lda.
8. Sabores Púrpura, Lda.
9. RPK Biopharma, Unipessoal, Lda.
10. Terra Verde, Ltd.
11. Tilray Portugal, Unipessoal, Lda.
12. Grovida, Ltd.
13. Canna Forest, Ltd.
14. Pure Healing Ltd.
15. Ferraz Lynce Especialidades Farmacêuticas, SA
16. Cannprisma – Pharma, Lda.
17. Weez Garden, Unipessoal Lda.
18. Sociedade Agrícola Monte das Barrocas, Lda.
19. Cannexpor Pharma, Lda.
20. 20Agrivabe Medical Cannabis
21. Symtomax Unipessoal, Lda.
22. Agrovete, SA
23. berfar Indústria Farmacêutica, SA
24. Noidecs, Unipessoal, Lda.
25. Galaxiavertical – Unipessoal, Lda.
26. Canneurox Portugal Unipessoal SA (Avextra)
27. Somaí Pharmaceutical, Unipessoal Lda.
28. 28 Sun Light Greens SA
29. Belvedere Pharma SA
30. GBE Pharma Unipessoal Lda.
31. Schroll Flavors Produção e Comercialização de Produtos Agrícolas Unipessoal Lda.
32. Jazz Pharmaceuticals France – Branch in Portugal

Companies Licensed To Export Preparations And Substances Based On The Cannabis Plant

1. Key Leaves, Ltd.
2. Ferraz Lynce Especialidades Farmacêuticas, SA
3. Pure Healing Ltd.
4. Qanali Ltd.
5. Portocanna, SA
6. SMC Therapeutic Health Center Production, Ltd.
7. Somaí Pharmaceutical, Unipessoal Lda.
8. RPK Biopharma, Unipessoal, Lda.
9. Sabores Púrpura, Lda.
10. erra Verde, Ltd.
11. Tilray Portugal, Unipessoal, Lda.
12. Canna Forest, Ltd.
13. Sociedade Agrícola Monte das Barrocas, Lda.
14. Cannexpor Pharma Lda.
15. Cannprisma – Pharma, Lda.
16. Grovida, Ltd.
17. Weez Garden, Unipessoal Lda.
18. Symtomax Unipessoal, Lda.
19. Agrivabe Medical Cannabis
20. Agrovete, SA
21. Labialfarma Laboratory of Pharmaceuticals and Nutraceuticals SA
22. Smart Nature, Ltd.
23. Iberfar Indústria Farmacêutica, SA
24. Noidecs, Unipessoal, Lda.
25. Galaxiavertical, Unipessoal, Lda.
26. MHI Cultivo Medicinal, SA (Medicane)
27. Canneurox Portugal Unipessoal SA (Avextra)
28. Belvedere Pharma SA
29. Blossom Genetics Unipessoal Lda.
30. GBE Pharma Unipessoal Lda.
31. Sun Light Greens SA
32. Schroll Flavors Produção e Comercialização de Produtos Agrícolas Unipessoal Lda.

Companies With Eu-Gmp Certification

1. Infosaúde – Institute for Training and Innovation in Health SA
2. Tilray Portugal, Unipessoal, Lda.
3. Portocanna SA
4. QPLab Pharma Services Lda.
5. RPK Biopharma Unipessoal Lda.
6. Agrivabe Medical Cannabis
7. Labialfarma Laboratory of Pharmaceuticals and Nutraceuticals SA
8. Iberfar Indústria Farmacêutica SA
9. Blossom Genetics Unipessoal Lda.
10. MHI Cultivo Medicinal SA (Medicane)
11. Alloga Logifarma, SA
12. Bluestabil – Stability Studies Services, Lda
13. ociedade Agrícola Monte das Barrocas, Lda.
14. Somaí Pharmaceutical, Unipessoal Lda.
15. Cannprisma – Pharma, Lda.
16. ISQ – Institute of Welding and Quality
17. Technophage, Research and Development in Biotechnology SA

Note that these lists are constantly updated on the Infarmed website.

Who Is The Largest Exporter Of Cannabis In Europe?

Portugal ranks as the second-largest producer of medical cannabis in the European Union (EU). With an annual declared production of 34 tonnes of medical cannabis, the country is close behind another major European producer, which claimed 36 tonnes. 

The Portuguese medical cannabis industry is tightly regulated, with a strong emphasis on safety and quality. Despite this focus, there’s criticism regarding the limited access for patients who need medical cannabis. The current legal framework in Portugal aims to provide access, but it hasn’t fully achieved its goal of making medical cannabis widely available to patients.

Magistral Formulations

One possible solution for improving access in Portugal could involve following the example of countries like Germany, where pharmacies can provide custom-prepared cannabis flowers and extracts based on medical prescriptions, referred to as magistral formulations.

The Challenges of Medical Cannabis Access in Portugal

There’s a significant challenge across Europe regarding the lack of mutual recognition for medical cannabis. Unlike traditional medicines, which can be sold across the EU once approved in one country, medical cannabis products aren’t automatically recognized across borders. 

Efforts to improve access to medical cannabis in Europe continue, with a recent European Commission initiative pushing for better access and the legal transportation of medical cannabis across the EU. If the initiative garners enough support, it could lead to new legislation that would ease access to medical cannabis for patients throughout Europe.

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Uncomplicate Your Cannabis Production Today With Grower IQ!

Seed-to-sale tracking is a critical component of cannabis compliance software. Cannabis businesses must track their products from when they are seeds to when they are sold to customers. This means monitoring the plants throughout the entire growth process and tracking the various products created from them.  

If of these products individually so that you can monitor their contents, understand their origins, and follow regulation requirements. Suppose a customer were to report an issue with one of these products. In that case, you’d need to be able to quickly reference your records and any associated reports to understand their concerns and address them accordingly. 

Compliance Software

If you fail to track your cannabis products properly, not only could you put your customers at risk, but you could also face severe penalties from regulators. Grower IQ’s cannabis compliance software can help you avoid these issues by automating the seed-to-sale tracking process. 

Our solution integrates with various sensors and devices to automatically capture data on cannabis plants and products. This means you won’t have to rely on time-consuming manual processes prone to human error.

Simplified Operations

With Grower IQ, you can simplify your operations and ensure full compliance with regulatory requirements.

Ensure Cannabis Quality with Cultivation Planning

Cultivation planning helps growers optimize their operations to produce quality cannabis. The process involves mapping out how you will cultivate your cannabis plants, including their growth conditions, any potential issues that may arise, and how you will address them, as well as detailed notes on your plants’ development. 

This process can help growers improve consistency and ensure regulatory compliance while cultivating their cannabis plants. With GrowerIQ’s cultivation planning tools, you can create detailed reports on your cannabis plants’ health and development as they progress through the growth cycle.

Data Analysis

These reports can help you identify anomalies and deviations from the norm that could indicate a problem. More importantly, by following the data and understanding what these issues could mean, you can develop a plan to address problems before they affect quality. Cultivation planning can also assist you in achieving your goals for cannabis quality. 

As you produce detailed reports on your cannabis plants, you can reference these documents to help you maintain consistency in your operations as you work towards specific targets for cannabinoid and terpene profiles.

Optimize Your Cannabis Operations with Quality Management Tools 

Quality management is a crucial part of cannabis compliance. Regulatory bodies require growers to produce cannabis that meets specific standards and wants documentation proving they’ve achieved their goals. Failing to meet cannabis quality standards can put consumers at risk and lead to penalties for your operations. 

Quality management processes help cannabis growers identify and mitigate risks affecting product safety and consistency. Cannabis quality management starts with planning for regulatory compliance and understanding the specific criteria you must meet.

Cultivation Planning

From there, you can develop detailed cultivation plans to help you achieve your goals and stay within the confines of the law. As you implement your plans, quality management processes will allow you to monitor the health of your cannabis plants so you can identify any issues that could affect quality and address them before they cause problems.