Get an overview of Portugal’s medicinal cannabis laws and regulations
In recent years, the topic of Medicinal Cannabis Portugal has become increasingly significant, especially given the rapid expansion of Cannabis Plantation in Portugal. As more people turn to cannabis for its therapeutic benefits, understanding the nuances of medicinal cannabis laws and regulations in Portugal becomes crucial. This article aims to provide valuable insights and guidance to help you navigate these complexities and achieve your goals of legal cannabis use.
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Laws & Regulations on Medicinal Cannabis Portugal
Portugal has laid the groundwork for medicinal cannabis through Law No. 33/2018 and Decree-Law No. 8/2019. These legislative acts serve as the backbone for the:
- Cultivation
- Manufacturing
- Distribution of cannabis-based products
Essentially, cannabis is used for medicinal purposes when conventional treatments fail or cause nasty side effects. The law sets clear guidelines for these activities, ensuring they’re regulated and supervised effectively.
Want to get into the medicinal cannabis game in Portugal? You must review the licensing process outlined in Ministerial Order 83/2021. This means submitting a detailed application to INFARMED, the key player in this space. They’ll want to know your plans, from security measures to operational specifics. No shortcuts here. INFARMED takes about 90 days to thumb through your application, and they’re not doing it alone. They team up with SICAD to make sure everything checks out.
Prescription Protocols for Patients
Cannabis-based products can only enter the scene when traditional treatments have thrown in the towel. Doctors must use a particular medical form to prescribe these products, which requires much information, from patient details to the product’s specifics.
INFARMED also has a say in what these products can be prescribed for, ensuring they’re only used when necessary. So, you can’t just waltz into a pharmacy and pick up your prescription; these products are doled out with caution and care.
What You Need to Know About Dispensation
Once you’ve got a prescription, you’ll need to head to a pharmacy to get your cannabis-based medicine. Only licensed pharmacists can dispense these products, and patients can only possess the amount prescribed. This is all about ensuring that these medicines are used responsibly and effectively. So, no room for error here. Everything is tightly controlled to prevent misuse or abuse.
Keeping Cannabis Production Secure
Ministerial Order 83/2021 contains serious security measures for cannabis production sites. We’re talking about:
- Video surveillance
- Intrusion detection systems
- On-site security guards
These measures vary depending on the scope of your activities. So, if you’re just dabbling in cultivation, your security needs might be slightly different than if you’re doing full-scale production. But one thing’s for sure: security is not something to skimp on.
Pricing and Economic Considerations
Ministerial Order No. 44-A/2019 sets the rules for pricing cannabis-based products. The license holder proposes a price based on international market trends, but INFARMED gets the final say. If they don’t like what you’re asking, they can reject your proposal, forcing you back to the drawing board to create a new price. This ensures that prices remain fair and competitive, preventing companies from cornering the market.
Managing Cannabis Waste Responsibly
Cannabis waste management is a big deal in Portugal. In 2022, INFARMED and the Portuguese Environmental Agency released a technical note on the subject, requiring producers to follow the waste hierarchy principle. This means:
- Minimizing waste
- Reusing materials whenever possible
- Recycling what can’t be reused
Producers also need to report their waste data to the Integrated Electronic Waste Registration System (SIRER), so there’s no hiding what’s going on behind closed doors.
Medicinal Cannabis vs Recreational Cannabis In Portugal
Portugal legalized medicinal cannabis in 2018. Patients with certain medical conditions can access cannabis-based products with a prescription from a licensed healthcare professional.
The Portuguese National Authority of Medicines and Health Products, known as Infarmed, regulates the market, ensuring that products meet strict quality standards. Medicinal cannabis is available only through pharmacies and is restricted to treating specific conditions, such as:
- Chronic pain
- Multiple sclerosis
- Certain forms of epilepsy
This framework emphasizes safety and efficacy, allowing patients to benefit from cannabis without fear of legal repercussions.
Recreational Cannabis: Illegal but Decriminalized
Recreational cannabis use remains illegal in Portugal, but the country has taken a progressive approach by decriminalizing the possession and use of small amounts for personal use. This policy, implemented in 2001, means individuals caught with small quantities (up to 25 grams of cannabis or 5 grams of hashish) are not subject to criminal prosecution. Instead, they may face administrative penalties, such as:
- Fines
- Treatment programs
This approach reflects Portugal’s commitment to treating drug use as a health issue rather than a criminal one.
The Future of Cannabis Legalization: Slow Progress
Efforts to legalize cannabis for non-medical use have been slow, with proposals from different political parties offering varying approaches to state control and regulation. Despite public and politicians’ support, 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. This lack of progress reflects the challenges of navigating a complex and evolving legal landscape as stakeholders work to balance legalization’s potential benefits and risks.
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How To Get License To Grow Cannabis In Portugal
Securing a cannabis license in Portugal involves working with Infarmed I.P., the nation’s primary authority on cannabis activities. They oversee everything from cultivation to transport and ensure that activities adhere to national needs focused on:
- Medical
- Veterinary
- Scientific
- Educational interests
The specifics are in Decree-Law No. 15/93 and Regulatory Decree No. 61/94.
The Role of Ordinance 83/2021
Ordinance 83/2021, issued on April 15, 2021, clarifies the licensing process, making it more transparent and understandable. This ordinance outlines the security requirements, including a mandatory police inspection. It simplifies things for applicants, ensuring they know exactly what’s needed to get through the process.
How the Electronic Submission and Licensing Portal Works
You’ll need to submit applications for activities like:
- Cultivation
- Manufacturing
- Distribution electronically
The “Pedidos de licenciamento” page has the forms you’ll need, and the “Portal Licenciamento” is your go-to spot for submitting, monitoring, and managing your applications. This portal is crucial for the wholesale distribution of:
- Drugs
- Medical devices
- Active substances
Compliance with Good Practices
Once you’ve got your license, adherence is non-negotiable to:
- Good Agricultural Practices (GAP)
- Good Manufacturing Practices (GMP)
- Good Distribution Practices (GDP)
For manufacturing and wholesale activities, you’ll receive authorization and a certificate of Good Practices that is publicly available on the European EudraGMDP database. This ensures your operations meet the high standards for quality and safety.
Handling Import, Export, and Transit Operations
Each time you import, export, or transit cannabis, you’ll need the following:
- Official Import Certificate
- Export Certificate
- Transit Certificate
This involves submitting the proper application and paying a fee. It ensures that all international movements of cannabis products are appropriately documented and regulated.
Annual EUA Application Requirement
Every September, you must submit an annual application for an Emergency Use Authorization (EUA) for medicinal products with well-recognized clinical benefits. This ensures that these products are available for medical use under regulated conditions.
Understanding the Licensing System
Portugal uses a pre-license/provisional license system with specific fees for different activities:
- €3,000 for cultivation and manufacture
- €1,000 for wholesale trade and transit
- €1,200 for import and export
Keep in mind holding a license doesn’t authorize you to use the medicines or substances yourself.
Is Cannabis Oil Legal In Portugal? The Legal Status Of CBD
Yes, CBD is legal in Portugal for medicinal use with a prescription, and you shouldn’t face legal trouble for possessing CBD products with less than 0.2% THC. But the legal status of cannabidiol is a bit more complicated.
Portugal’s Decriminalization of Drugs: A Closer Look
In 2001, Portugal decriminalized the possession and use of all drugs, including cannabis. Today, if authorities catch you with a small quantity of drugs (enough for less than ten days of personal use), the Commission for Dissuasion of Drug Addiction must examine you. This committee of legal and medical experts and social workers determines if you need treatment and whether there will be administrative penalties.
CBD itself was utterly legal until 2018. Then, following the EU’s novel food law, Portugal banned CBD as a food product. Also, in 2018, medical cannabis became legal, and people could purchase it from pharmacies with a licensed doctor’s prescription.
Some conditions that make a patient eligible for a prescription include:
- Nausea from chemotherapy
- Chronic pain
- Post-traumatic stress disorder
- Epilepsy and more
So, while many believe that CBD products fall in the category of medical cannabis and you need a prescription to buy them, possessing products with less than 0.2% THC shouldn’t be problematic.
Market Size Of Medicinal Cannabis In Portugal
Portugal’s medical cannabis market is gaining traction. Revenues are anticipated to reach US$7.50 million by 2024, with projections pushing this figure to US$9.23 million by 2029. This growth is driven by a compound annual growth rate of 4.24%. While these figures may seem modest compared to the U.S., where the market is expected to reach US$14.5 billion, Portugal’s role in the European cannabis scene is expanding.
Why Is There a Growing Demand for Medicinal Cannabis in Portugal?
The demand for medical cannabis in Portugal is surging as patients explore its potential to alleviate:
- Chronic pain
- Epilepsy
- Multiple sclerosis
There’s a shift towards cannabis as a natural, plant-based remedy over conventional pharmaceuticals. This trend is part of a broader global movement recognizing the therapeutic benefits of cannabis.
Expanding Product Range: What Options Do Patients Have?
Portugal’s medicinal cannabis market is diversifying. Patients now have access to a wide range of products, including:
- Oils
- Tinctures
- Capsules
- Topicals
This variety caters to different treatment needs and indicates that the market is maturing, becoming more accessible to diverse consumers.
Why Portugal’s Laws and Location Are Ideal for Cannabis Growth
Portugal’s progressive drug policies have been instrumental in the growth of its medicinal cannabis market. After decriminalizing all drug use in 2001, Portugal legalized medicinal cannabis in 2018. This legal framework supports industry growth, and the country’s location in Europe makes it a strategic hub for exporting cannabis-based products to other countries.
Economic Contributions: How Does Medicinal Cannabis Benefit Portugal?
On a macroeconomic level, Portugal’s medical cannabis sector offers opportunities for:
- Investment
- Job creation
- Revenue generation
As the industry expands, local companies will likely form partnerships with international firms, fostering innovation and increasing the country’s prominence in the European cannabis scene.
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Buying Medicinal Cannabis
Patients seeking medicinal cannabis in Portugal must secure a particular prescription from a licensed healthcare professional. Doctors can prescribe these treatments when conventional options fall short or cause troublesome side effects. The prescription needs to include:
- All relevant details about the patient
- Specific cannabis product
- Dosage
- Method of consumption
This ensures patients receive a tailored treatment plan that best suits their needs.
Where to Get Your Medicinal Cannabis in Portugal
In Portugal, medicinal cannabis can only be dispensed through licensed pharmacies. Patients can’t just walk in and purchase it over the counter. It’s also not available for online purchase. You’ll need to present the prescription to the pharmacist, who will verify the prescription and your identity before handing over the product. This process ensures that patients are only obtaining cannabis for legitimate medical reasons.
The Range of Available Products
Cannabis-based products available in Portugal include:
- Oils
- Capsules
- INFARMED
INFARMED is critical in regulating the market to ensure all products meet quality and consistency standards. This provides patients with safe and effective treatments.
Know Your Rights as a Patient
Once you have your medicinal cannabis, you are allowed to possess and transport it for personal use, as indicated by the prescription. Remember that any possession or use of cannabis outside of these guidelines is still illegal under Portuguese law.
FAQs On Medicinal Cannabis In Portugal
Medicinal Cannabis in Portugal: What’s Available?
Medical cannabis is indeed available in Portugal. Legalized in 2018, it’s prescribed and distributed through pharmacies. Recent developments have expanded options for patients, with the Portuguese medical cannabis regulator approving new preparations.
Initially, Tilray’s 18% THC dried flower was the only product, but various oils and flower preparations have been added. These aim to treat conditions such as:
- Chronic pain
- Epilepsy
- Chemotherapy-related nausea
Who’s Leading the Medicinal Cannabis Market?
Portugal is a significant player in the EU’s medical cannabis scene. It is currently the second-largest producer, with an annual declared production of 34 tonnes. It is just behind another top European producer, which has 36 tonnes.
Portugal’s Medical Cannabis
The Portuguese industry focuses on safety and quality, but there’s criticism about limited patient access. The legal framework aims to provide access but has yet to succeed fully. Looking at countries like Germany, where pharmacies provide custom-prepared cannabis flowers and extracts, could be a way forward.
Harmonizing Medical Cannabis Regulations in Europe
A significant challenge is the lack of mutual recognition for medical cannabis across Europe. Unlike traditional medicines, medical cannabis isn’t automatically recognized across borders. A European Commission initiative is pushing for better access and legal transportation of medical cannabis across the EU. If enough support is garnered, it could lead to new legislation easing access for patients throughout Europe.
Cannabis Oil: Legal and Available
Cannabis oil is legal in Portugal for medical use. Recent regulatory approvals include CBD-dominant oils for various medical applications. These products require a doctor’s prescription and must be dispensed through licensed pharmacies. This careful regulation ensures that patients receive high-quality and safe products for their medical needs.
The Decriminalization Journey: Why Portugal Took the Leap
Cannabis decriminalization in Portugal was part of a broader drug policy reform in 2001 that decriminalized all drugs. The goal was to address drug addiction as a public health issue instead of a criminal one. This approach led to reduced drug-related deaths and crime rates while decreasing the stigma around drug use.
Advocates for further legalization continue to push for separating cannabis from other drugs and making it more accessible for recreational and medical use.
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