Learn the effective way of growing cannabis in Portugal
Imagine you are a farmer looking to diversify your crops. You’ve heard the stories of how lucrative cannabis plantations in Portugal are as the climate is ideal for growing it. But you also know that laws govern its cultivation and must understand them before planting. This blog will help you get started with the information you need about cannabis laws and usage in Portugal for farmers.
GrowerIQ’s cannabis production software can help you achieve your goals around cultivating cannabis in Portugal. It can help you track and document your growing operations to help you stay compliant with local laws and regulations.
Cannabis Portugal: What The Current Laws Say
Producing, importing, and selling cannabis for medicinal purposes is permitted in Portugal. Portugal’s favorable climate and strategic location make it an ideal environment for cannabis cultivation and export. The country’s outdoor growing conditions allow for cannabis to be produced at a lower cost compared to other European countries, making it a competitive player in the global cannabis market.
Growing Cannabis In Portugal
Cannabis use in Portugal is decriminalized but must be prescribed by a doctor. The country is known for having some of the most progressive cannabis laws globally. 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.
The Role of Infarmed I.P. in Cannabis Regulation
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.
Medicinal Cannabis vs Recreational Cannabis In Portugal
Portugal legalized medicinal cannabis in 2018. Under this framework, patients with specific medical conditions can access cannabis-based products with a prescription from a licensed healthcare professional. The medicinal cannabis market is regulated, and products must meet strict quality standards set by Infarmed, the Portuguese National Authority of Medicines and Health Products.
Medicinal cannabis is only available through pharmacies, and its use is restricted to treating certain conditions such as:
- Chronic pain
- Multiple sclerosis
- Some forms of epilepsy
Recreational Use of Cannabis in Portugal
Recreational use of cannabis remains illegal in Portugal. The country has taken a progressive approach by decriminalizing the possession and use of small amounts of cannabis for personal use as part of its broader drug decriminalization policy implemented in 2001.
This means that while recreational cannabis use is not legal, individuals caught with small quantities (up to 25 grams of cannabis or 5 grams of hashish) for personal use are not subject to criminal prosecution but instead may face administrative penalties, such as fines, or be referred to a treatment program.
Future of Cannabis Legalization in Portugal
As of June 2020, efforts have been made to advance legislation to legalize cannabis for non-medical use. Progress has been slow. Portugal has seen proposals from different political parties with varying approaches to state control and regulation, but a consensus has yet to be reached.
The legislative process stalled in December 2021, when proposals expired at the end of the parliamentary session, putting Portugal behind other European countries in legalizing adult-use cannabis.
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How To Get License To Grow Cannabis 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.
Ordinance 83/2021 and the Cannabis 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.
Electronic Submission and the Cannabis Licensing Portal
Applications for authorizations to engage in activities such as cultivation, manufacturing, wholesale trade, import, export, transport, and 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.
Compliance 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.
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 and regulated.
Annual EUA Application Requirement
Applicants must submit an annual application during September for an Emergency Use Authorization (EUA) for medicinal products with well-recognized clinical benefits. This requirement ensures that such products are available for medical use under regulated conditions.
The Cannabis Licensing System
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’s medicinal cannabis industry is growing rapidly, and the country has become a significant player on the global stage. As of 2023, Portugal has 42 licensed companies operating in the sector, a 23.5% increase from 2022. 150 entities are currently 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.
How is the Licensing and Certification Status in Portugal?
Currently, Portugal has:
- 24 companies licensed for cannabis cultivation
- 15 for manufacturing
- 12 for wholesale trade
- 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.
Who is Buying Portugal’s Medicinal Cannabis?
Portugal exported over 5.4 tons of medicinal cannabis by August 2023, primarily to:
- Germany
- Poland
- Australia
However, 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.
What’s Happening with New Entrants in Portugal’s 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.
Are Companies Exiting the Cannabis Market in Portugal?
While the industry grows, some companies have exited or lost their licenses. Clever Leaves discontinued operations in Portugal and three other companies:
- Empifarma
- Medlog
- Cooprofar
These companies 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.
Is CBD Legal In Portugal?
Recent global trends indicate that cannabidiol (CBD) and its associated benefits are becoming increasingly popular in:
- Health
- Wellness
CBD Oil Legality
Despite the illegal status of cannabis in many countries, the same does not apply to the widely used CBD oils extracted from the plant. These oils and other CBD products are part of a more significant global phenomenon and can be easily purchased, especially in:
- Europe
- North America
Portugal’s approach to CBD is rather complex. The cultivation of hemp for industrial purposes is a lawful activity. An amendment to Regulatory Decree 61/94 transposed Community law into national law. The Administrative Rule 14/2022, of 5 January, provides that hemp can only be cultivated outdoors.
Cannabis Cultivation Laws
Cultivation can only occur in an area of at least five hectares; transplanting of plants is not allowed, and the density of sowing can be at least 30 kg 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).
CBD exists in a legal grey area. Marketing CBD is prohibited in Portugal. 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 in accordance with the rules for the cultivation and marketing of controlled substances (essentially for medicinal purposes).
Cannabis Food Restrictions
The use of cannabinoids (such as CBD and THC) in food will mean that such foods are considered unauthorized novel foods, similar to plant parts and their extracts. In a recent statement, the DGAV stated 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
- Food Ingredients Regulation
Market Potential Of Cannabis & Hemp In Portugal
The cannabis market in Portugal is growing by leaps and bounds. So much so that in 2021, Portugal’s National Medical Authority, Infarmed, reported that the country exported approximately 30 tons of dried cannabis in 2021, which is a 600% increase from the misely 4.5 tons exported in 2020.
The Future of the Cannabis Market in Portugal Looks Promising
According to Statista, revenues in the Portuguese cannabis market are projected to reach $180.3m in 2023 (a 29% growth from 2022) and grow at an annual rate of 15.02% from 2023 to 2028. Thus, the Portuguese market is expected to grow to $363m by 2028.
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Growing Medical Cannabis In Portugal, how Does GrowerIQ Help?
In Portugal, the cannabis regulatory framework is detailed and strict. GrowerIQ helps cannabis producers comply with regulations to cultivate hemp by streamlining recordkeeping and operational processes.
How GrowerIQ Helps LPs Comply With GACP & GMP
Here are some of the ways GrowerIQ helps licensed producers meet Good Agricultural and Collecting Practices (GACP) and Good Manufacturing Practices (GMP) as outlined by INFARMED in Decreto Regulamentar n.º 61/94, de 12 de outubro. Digital recordkeeping is more reliable than paper. Cannabis is a complex and highly regulated industry.
As such, a lot of documentation must be kept in order. Keeping records on paper can quickly become chaotic. Digital recordkeeping systems like GrowerIQ help cultivate compliance by organizing and systemizing records so they can be easily accessed and sorted.
Batch Tracking and Documentation in Cannabis Production
Batch numbering and batch status control Every cannabis grower will tell you that not all batches are created equally. There can be considerable variations in the chemical composition of different batches of cannabis, even if they come from the same mother plant. For this reason, regulators are particularly interested in how cannabis is tracked and documented from the moment it is harvested until it is finally sold to a consumer.
Cannabis Cultivation with GrowerIQ’s Software
Using GrowerIQ’s cannabis cultivation software, you can create detailed, organized records for each batch of cannabis and their respective sub-units. This will make it easy to:
- Track variations in different batches
- Comply with regulatory requirements
Seed-to-sale tracking of cannabis and accounting of weights and yields GrowerIQ’s seed-to-sale tracking capabilities allow you to track cannabis from the moment it is propagated until it is sold to a customer. Along the way, you can document individual plants, their characteristics, their cultivation, and any variations.
This will ensure you remain compliant with regulations that require growers to keep detailed records of their operations and will help you produce quality cannabis.
- Client tracking
- Inventory control
- Quality management software functions
- Cultivation and monitoring software functions ERP software functions
Uncomplicate Your Cannabis Production Today With GrowerIQ!
Cannabis operators face significant challenges related to compliance. GrowerIQ helps producers manage compliance by tracking and organizing critical data to ensure cannabis businesses can:
- Operate smoothly
- Meet regulatory requirements
Related Reading
- Industrial Hemp
- Cannabis Companies Portugal
- Cannabis Seeds
- Cannabis Cultivation Portugal
- How to Sell Cannabis in Portugal
- CBD Legislation Portugal
- Portugal Cannabiscafe
- Medicinal Cannabis Portugal
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