Learn how to set up a legal cannabis plantation in Portugal
Cannabis plantations in Portugal are gaining traction, specifically since the country legalized the medicinal use of cannabis in 2018. If you’re thinking about starting your cannabis farm in Portugal, you’ll want to familiarize yourself with the country’s cannabis laws and regulations. In this article, we’ll provide valuable insights as to how to grow cannabis in Portugal legally and successfully.
GrowerIQ’s cannabis production software can help you meet these objectives and get your cannabis farm off to a good start. The user-friendly platform offers a wealth of resources for cannabis cultivators, including tools for tracking and optimizing plant health, production processes, and compliance with local regulations.
History Of Cannabis In Portugal
Once a dominant world power, it’s unsurprising that Portugal encountered cannabis during its overseas operations. The colonial Portuguese will likely have encountered it in India, Mozambique, and Angola, all countries under Portuguese control for many years. It’s even believed that the Portuguese brought cannabis to Brazil in the 16th century—either themselves or by the slaves they were transporting at the time.
From this, it’s reasonable to conclude that Portuguese traders were bringing hashish and cannabis back to their homeland for several hundred years. Portugal also has an illustrious history of hemp cultivation. Its people have been using the plant to create ropes and sails for centuries, which may have contributed to their reputation as great seafarers.
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Cannabis Laws In Portugal
Portugal’s cannabis laws are some of the most progressive in the world. Cannabis use in Portugal is decriminalized but must be prescribed by a doctor. In 2001, Portugal decriminalized personal cannabis use, shifting the focus from punishment to treatment, which led to a decrease in the number of drug users.
Medicinal cannabis was later legalized in 2018, further expanding the legal framework surrounding cannabis use in the country. João Goulão, Portugal’s national drugs coordinator, played a significant role in pushing these legal changes.
Infarmed I.P. and Cannabis Regulation in Portugal
All cannabis-related activities in Portugal require licensing from Infarmed I.P., the agency under the Portuguese Health Ministry responsible for regulating medicines and health products. Infarmed I.P. ensures that all cannabis cultivation and production adhere to stringent public health standards.
Future of Cannabis Legalization in Portugal
As of June 2020, Portugal has been working on draft legislation to legalize cannabis for non-medical use. Cannabis is decriminalized along with other drugs like heroin and cocaine, and the first legislative step would involve creating separate laws for cannabis.
Two political parties have proposed draft laws with differing levels of state control, but both agree on certain restrictions, such as purchase limits and designated smoking areas. The legislative process for legalizing adult-use cannabis has stalled, as the proposals expired with the end of the parliamentary session in December 2021, delaying progress compared to other European nations.
Cannabis growers face challenges in:
- Managing reporting
- Documentation
- Compliance requirements
Due to the complexity of regulatory frameworks, evolving legal standards, and the need for accurate record-keeping in a highly regulated industry.
GrowerIQ Solutions
At GrowerIQ, our software aims to provide cannabis growers with a comprehensive solution for:
- Managing their cultivation operations
- Ensuring compliance
- Optimizing quality
- Enhancing efficiency throughout the seed-to-sale process
- Overall uncomplicating the production process
We do this with our software, which offers a range of functionalities to assist cannabis growers, including:
- Seed-to-Sale Tracking
- Quality Management
- Cultivation Planning
Setting Up A Legal Cannabis Plantation In Portugal
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.
All About Ordinance 83/2021 and the Licensing Process for Cannabis Activities in Portugal
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.
Electronic Submission and Licensing Portal
Applications for authorizations to engage in activities such as:
- Cultivation
- Manufacturing
- wholesale trade
- Import
- Export
- Transport
- Circulation
Applications for the licensing 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, and 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.
Compliance with Good Practices for Cannabis Cultivation and Operations
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.
Import, Export, and Transit Operations for Cannabis Activities in Portugal
Each import, export, and transit operation involving cannabis requires:
- Official Import
- Export
- 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 and regulated.
Annual EUA Application Requirement for Cannabis Products in Portugal
Applicants must submit an annual application for Emergency Use Authorization (EUA) 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 for Cannabis Activities in Portugal
There is a pre-license/provisional license system. Licences 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.
Growth In Portugal’s Medicinal Cannabis Industry
Portugal is emerging as a significant player in the global medicinal cannabis industry. As of 2023, 42 licensed companies operate in the sector, a 23.5% increase from 2022. There are also 150 additional entities in the licensing process, suggesting further growth shortly.
Infarmed, Portugal’s National Authority for Medicines and Health Products issued 76 new authorizations for various cannabis activities this year, with 265 more requests pending. The licensed activities include cultivation, manufacturing, import/export, and wholesale distribution.
Licensing and Certification Status
Currently, Portugal has 24 companies licensed for cannabis cultivation, 15 for manufacturing, 12 for wholesale trade, and 32 for import/export. 17 companies have obtained EU-GMP (Good Manufacturing Practices) certification, ensuring they meet high standards for quality and safety in manufacturing.
Export Growth and Domestic Prescription Challenges
Portugal exported over 5.4 tons of medicinal cannabis by August 2023, primarily to Germany, Poland, and Australia. Domestic consumption remains low, with only 524 packages of medicinal cannabis prescribed within the country. The only available product for Portuguese patients is Tilray Flor Seca, with 18% THC.
New Entrants in the Cannabis Market
In 2023, several new companies entered the medicinal cannabis market in Portugal, gaining licenses in various sectors such as:
- Cultivation
- Manufacturing
- Wholesale trade
- Import/export
Notable new entrants include:
- Sun Light Greens
- Belvedere Pharma
- Jazz Pharmaceuticals France
Seven new companies received EU-GMP certification, enhancing their credibility in the market.
Companies Exiting the Market
While the industry grows, some companies have exited or lost their licenses. Clever Leaves discontinued operations in Portugal, and three other companies—Empifarma, Medlog, and Cooprofar—lost or did not renew their wholesale trade licenses. This reflects the dynamic nature of the market, where companies may exit due to various challenges.
Industrial Hemp in Portugal
The cultivation of hemp for industrial purposes is a lawful activity in Portugal, having first been authorized and encouraged by Community law; it was then transposed into national law by an amendment to Regulatory Decree 61/94 (establishing rules for the control of the lawful market in narcotic drugs and psychotropic substances).
What Are the Rules for Cultivating Industrial Hemp in Portugal?
The Administrative Rule 14/2022, of 5 January, provides that:
- Hemp can only be cultivated outdoors (it is not possible to grow in greenhouses or closed spaces)
- Cultivation can only take place in an area of at least five hectares
- Transplanting of plants is not allowed
- The density of sowing can be at least 30kg per hectare.
- It is also forbidden to transport flowering plant juices off the farm (even if they can no longer be used for industrial hemp cultivation).
- Rules have also been established on reusing opened seed packages.
What About CBD?
As regards CBD, it is, from a legal point of view, in a grey area. In Portugal, the marketing of CBD is classified by the authorities as a prohibited activity insofar as CBD, as a substance extracted from the flowers and leaves of the cannabis plant (and not from the stalks and seeds), must be treated as a controlled substance. The plant may only be cultivated and marketed by the rules for cultivating and marketing controlled substances (i.e., essentially for medicinal purposes).
In ASAE’s view, the use of cannabinoids such as:
- CBD
- THC
- Cannabigerol (CBG)
- Cannabinol (CBN)
Food will mean that such foods are considered unauthorized novel foods, similar to plant parts and their extracts. The commercialization of foods containing these substances is not authorized. The DGAV has also commented on this, stating that CBD has no history of consumption as a food or food ingredient in the EU before 1997, and it cannot be used in food as it does not meet the requirements of the Novel Foods and Food Ingredients Regulation (EU) 2015-2283. CBD must undergo a risk assessment by EFSA before being placed on the market.
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Cannabis Market Size In Portugal
The cannabis market in Portugal is growing rapidly. In 2021, Portugal’s National Medical Authority, Infarmed, reported that the country exported around 30 tons of dried cannabis, a 600% increase from the measly 4.5 tons exported in 2020.
Cannabusiness Revenues in Portugal
According to Statista, revenues in the Portuguese cannabis market are projected to reach $180.3 million in 2023, a 29% growth from 2022. Revenue is expected to grow at an annual rate of 15.02% from 2023 to 2028, which means the Portuguese market is expected to grow to $363 million by 2028.
Growing Medical Cannabis In Portugal, how Does GrowerIQ Help?
Cultivating cannabis in Portugal requires a thorough understanding of regulatory requirements. GrowerIQ helps growers mitigate the stress of compliance by making recordkeeping easier.
Complying with GACP & GMP Requirements
Good Agricultural and Collecting Practices (GACP) and Good Manufacturing Practices (GMP) are guidelines that help ensure the quality and safety of cannabis products. The laws and regulations outlined in Decreto Regulamentar n.º 61/94, de 12 de outubro are hefty and very detailed. Infarmed requires cannabis cultivators, processors, and manufacturers to adhere to GACP and GMP guidelines. There are rigorous requirements for recordkeeping and security that must be met. GrowerIQ does this with its software, which offers a range of functionalities to assist cannabis growers, including:
- Seed-to-Sale Tracking
- Quality Management
- Cultivation Planning
Producers must meet GACP and GMP regulatory requirements.
Digital Recordkeeping Is More Reliable Than Paper
Recordkeeping is a necessary evil when it comes to compliance. The more organized you are, the easier it will be to meet regulatory demands.
Using GrowerIQ’s cannabis management software means you can digitize all your records. This allows you to stay organized and easily locate files for audits and inspections when needed.
Batch Numbering and Batch Status Control
Another vital part of recordkeeping for cannabis compliance is batch control. Cannabis regulators want to know exactly where cannabis and its derivatives came from, how they were produced, and where they ended up. This means tracking the entire lifecycle of a batch of cannabis — from cultivation to processing, testing, and finally, distribution.
In GrowerIQ, each batch of cannabis is assigned a unique identification number. This number is used to track the batch throughout the software. As you collect data on the batch, it will be organized and stored in the software to ensure compliance with regulations.
Seed-to-Sale Tracking of Cannabis and Accounting of Weights and Yields
Cannabis compliance is all about tracking and tracing. Cannabis businesses must:
- Track cannabis plants
- Inventory
- Products
Throughout the entire lifecycle, from cultivation to processing, distribution, and sales. This is called seed-to-sale tracking. Using GrowerIQ’s cannabis management software, you can easily monitor the lifecycle of your cannabis plants and products and ensure accurate compliance reporting with regulators.
Client Tracking
Cannabis businesses must also track their customers, including individual clients and businesses. Using GrowerIQ, you can easily record and monitor customer information and transactions to ensure compliance with regulations.
Inventory Control
In addition to tracking cannabis plants and products, businesses must maintain strict inventory controls. This means accurately tracking the quantities of cannabis and all its derivatives at every stage of production and ensuring you can account for any discrepancies.
Using GrowerIQ’s cannabis inventory management software, you can ensure compliance with regulatory requirements and avoid costly penalties.
Quality Management Software Functions
Cannabis compliance is largely focused on ensuring the safety and quality of products. There are strict regulations concerning quality management.
Using GrowerIQ’s cannabis management software, you can implement standard operating procedures (SOPs) to ensure compliance with quality regulations. If you discover any quality issues, you can use the software to track and trace the affected cannabis products and establish documentation of any corrections made.
Cultivation and Monitoring Software Functions
There are also strict regulations governing cannabis cultivation and production. Using GrowerIQ’s cannabis management software, you can maintain compliance with these regulations to avoid costly penalties.
The software allows you to track and trace cannabis plants and monitor their growth. You can also create and implement SOPs to ensure compliance with quality regulations.
ERP Software Functions
Enterprise resource planning (ERP) software helps businesses integrate all their data and operate more efficiently, including cannabis compliance data.
Using GrowerIQ’s cannabis ERP software, you can ensure your business is audit-ready by maintaining organized and accurate compliance data that is easily accessible for inspections.
Uncomplicate Your Cannabis Production Today With GrowerIQ!
Cannabis growers face challenges in managing reporting, documentation, and compliance requirements due to the complexity of regulatory frameworks, evolving legal standards, and the need for accurate record-keeping in a highly regulated industry.
At GrowerIQ, our software aims to provide cannabis growers with a comprehensive solution for:
- Managing their cultivation operations
- Ensuring compliance
- Optimizing quality
- Enhancing efficiency throughout the seed-to-sale process
- Overall uncomplicating the production process
Software Features
GrowerIQ does this with its software, which offers a range of functionalities to assist cannabis growers, including:
- Seed-to-Sale Tracking
- Quality Management
- Cultivation Planning
GrowerIQ provides cannabis growers with a comprehensive solution for managing their:
- Cultivation operations
- Ensuring compliance
- Optimizing quality
- Enhancing efficiency throughout the seed-to-sale process
Related Reading
- Industrial Hemp
- Cannabis Companies Portugal
- Cannabis Seeds
- Cannabis Cultivation Portugal
- How to Sell Cannabis in Portugal
About GrowerIQ
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