October 7, 2026 · Regulatory Affairs
The Netherlands Steps Back From Cannabis Exports: Where Canadian EU-GMP Producers Fit
By Mussarat Fatima

Europe's medical cannabis market has leaned on the Netherlands for two decades. The Dutch Office of Medicinal Cannabis, known as the Bureau voor Medicinale Cannabis or BMC, has been the state channel that supplied standardised cannabis flower to pharmacies and wholesalers at home and across the continent. In the autumn of 2026 that channel is closing. The Dutch government is winding down direct international exports, and Bedrocan, the single grower it contracts, has filed for a court supervised suspension of payments. For Canadian licensed producers, this is not distant news. It is a supply gap opening in the one region where Canadian cannabis still competes on quality rather than on price.
This article is written for the chief executive, the founder and the head of regulatory affairs who need to understand what the Dutch retreat means and how to be ready for it. The short answer is that the opening favours producers who already hold, or can quickly earn, European pharmaceutical credentials. Those credentials are European Union Good Manufacturing Practice, usually written as EU-GMP, supported by Good Agricultural and Collection Practice, or GACP. Everything below explains why, and what to do about it.
Executive Summary
The Netherlands is ending state run medical cannabis exports by the close of 2026 and moving to an import based model through 2027 and 2028. European wholesalers, pharmacies and healthcare providers that relied on Dutch supply will need to qualify new sources. Canadian producers with EU-GMP certification and GACP compliant cultivation are well placed to compete for that volume, but only if their quality systems and batch records are ready for a European inspection and Qualified Person release.
What Is Changing in the Netherlands
In short: the Dutch Office of Medicinal Cannabis is phasing out direct international exports of medicinal cannabis by the end of 2026. Foreign orders are moving to the licensed producer, Bedrocan, rather than passing through the state office. The government plans to shift to imported cannabis through a European tender in 2027, with legislation to end the state monopoly expected to follow. The change matters because it removes a long standing, pharmaceutical grade source from the European supply chain at a time when demand is rising.
The trigger that put this in the headlines was financial. Bedrocan's two Dutch entities filed for a court supervised suspension of payments, reported at the end of September 2026, as the state moved its supply model away from exports. Bedrocan has said its deliveries to customers are not affected in the short term and that the larger risk to patients is the delay in changing Dutch law, not the suspension itself. What is clear is that wholesalers, pharmacies and healthcare providers outside the Netherlands can no longer rely on the state office as their export counterparty and will route supply requests directly through the producer.
The transition is staged rather than sudden, which gives buyers and new suppliers time to adjust. The table below sets out the expected sequence.
| Milestone | Expected timing | What it changes |
|---|---|---|
| Direct state exports wind down | By end of 2026 | The Office of Medicinal Cannabis stops handling foreign export orders |
| Foreign orders move to the producer | 2026 onward | Wholesalers, pharmacies and providers outside the Netherlands order through Bedrocan directly |
| Import based supply via European tender | 2027 | The Netherlands plans to source cannabis through a tender rather than rely on domestic state supply |
| Legislation to end the state monopoly | Expected late 2027 | A proposal would end the Office of Medicinal Cannabis monopoly on supply |
| Full implementation of the new model | Expected July 2028 | The import based model is expected to be fully in place |
Why the Dutch Retreat Matters for Canadian Producers
Why it matters: European demand for medical cannabis keeps growing while a long standing supply source contracts. A tighter Dutch supply pushes European wholesalers and pharmacies to qualify new, certified suppliers. Canadian producers that meet European pharmaceutical standards can compete for that volume, provided their certification and documentation hold up to scrutiny. What to do: make sure your European credentials are current and defensible before buyers start searching for replacement supply.
Germany is the clearest illustration. It is the largest regulated medical cannabis market in the world and its imports keep breaking records, yet Canada's share has been slipping as lower cost, newly certified origins scale up. We examined that shift in detail in our analysis of Canada's position in the German market. The lesson there applies directly here: the structural advantage that still protects Canadian access to Europe is regulatory, not agricultural. When a certified source like the Dutch channel contracts, the buyers it served do not disappear. They move to other certified suppliers.
Certification is achievable for Canadian producers of different sizes, not only the largest. In October 2026 Green Karat, a Quebec producer, secured EU-GMP certification to support exports into regulated markets including Germany, the United Kingdom and Australia. That matters as a proof point: a smaller licensed producer can earn the same credential that opens pharmacy shelves in Europe. The producers that treat certification as a revenue defence, rather than a document to collect later, are the ones positioned to take share as Dutch supply steps back.
What European Buyers Actually Require: EU-GMP and GACP
What it is: EU-GMP is the European Union's manufacturing quality standard for medicinal products, set out in EudraLex Volume 4. GACP governs the cultivation and harvest of herbal starting materials. Why it matters: medical cannabis sold through European pharmacies must be produced to these standards and released batch by batch by a Qualified Person. What to do: cover both the cultivation side, through GACP, and the processing and release side, through EU-GMP, and keep the records that prove it.
EU-GMP is not a certificate a company issues to itself. The site is inspected by a competent authority of an EU or EEA member state, and the outcome is recorded in the EudraGMDP database that buyers and regulators can check. The principles sit in EudraLex Volume 4, which covers the pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control and batch release. For a deeper walk through of how Canadian producers earn and keep the credential, see our guide to EU-GMP certification for Canadian cannabis producers.
GACP sits upstream of GMP. It applies to how the plant is grown, harvested, dried and handled before it reaches the manufacturing site, and the European Medicines Agency sets the expectation for herbal starting materials through its guidance on herbal medicinal products. Contamination, pesticide residues and inconsistent drying cannot be fixed by good manufacturing alone, which is why buyers look for GACP controls at the growing stage. A persistent trap for exporters is treating drying and post harvest handling as agricultural steps outside the quality system, when European buyers treat them as part of it. We covered that specific issue in our piece on Germany's drying rule and GMP washing.
Germany's 2024 reforms, which moved medical cannabis out of the narcotics framework and under a dedicated medical cannabis law, did not lower the pharmaceutical quality bar. Imported flower must still meet the European Pharmacopoeia monograph for cannabis flower and be released by a Qualified Person. The reform made prescribing easier, which grew demand. It did not make the quality requirements easier. The table below compares the two standards that gate European access.
| Standard | What it covers | Who assesses it | Why it matters for export |
|---|---|---|---|
| EU-GMP (EudraLex Volume 4) | Manufacturing, processing, packaging, testing and batch release of the finished medicinal product | An EU or EEA competent authority, through inspection recorded in EudraGMDP | Required for medical cannabis sold through EU pharmacies and underpins Qualified Person batch release |
| GACP (EMA guideline) | Cultivation, harvest, drying and primary handling of the herbal starting material | Assessed as part of the quality dossier and the GMP oversight of starting materials | Controls contamination, pesticides and consistency at the growing stage that GMP alone cannot correct |
Canada's Cannabis Export Pathway, Step by Step
How it affects compliance: exporting cannabis from Canada requires a federal licence under the Cannabis Act and a separate export permit from Health Canada for every shipment. Exports are allowed only for medical or scientific purposes, only to countries with a legal regime for access to cannabis for medical purposes, and only after the destination country issues an import permit. The European opening does not remove any of these steps. It raises the value of getting them right.
Health Canada sets out the controls on its import and export of cannabis page. The practical sequence for a producer looking at Europe is below. We walked through a market specific version of this in our guide to exporting Canadian cannabis to the United Kingdom.
- Hold the right Health Canada licence for the activity you intend, whether that is cultivation, processing or sale for medical purposes.
- Confirm the destination country has a legal medical cannabis regime and secure its import permit before any shipment moves.
- Apply to Health Canada for an export permit for that specific shipment, since a permit is required for each export and is not a standing authorisation.
- Meet the importing country's quality expectations, which for EU pharmacy supply means EU-GMP processing, GACP compliant starting material and Qualified Person batch release.
- Keep complete records of permits, test results, batch documentation and shipment data, because both Health Canada and the importing authority can ask to see them.
What Canadian Producers Should Do Now
What to do: treat certification as a commercial decision, not only a compliance project. Start with a gap assessment against EU-GMP and GACP, close the gaps, prepare for a competent authority inspection, and build the documentation that European buyers and Qualified Persons will demand. The producers who do this before a buyer comes looking are the ones who can say yes when the Dutch gap creates an opportunity.
The gaps that most often surface in a first EU readiness review are familiar from inspection practice: contamination control that is designed but not consistently evidenced, batch records with data integrity weaknesses such as uncontrolled spreadsheets or missing second checks, stability data that does not support the claimed shelf life, and Qualified Person release documentation that is incomplete. On the cultivation side, GACP records for pesticide use, water quality and drying are often thinner than the finished product file. Our cannabis GMP certification guide and our overview of Good Production Practices explain how the Canadian baseline maps onto the European expectation.
A mock inspection run by someone who knows what a competent authority looks for will surface these issues before the real inspection does, and gives you a documented corrective and preventive action, or CAPA, trail. A disciplined internal audit programme is the single most useful habit a producer targeting Europe can build, because it turns surprises into scheduled findings you control.
EU Export Readiness Compliance Checklist
Use this checklist to gauge how close your site is to supplying European pharmacies.
- Current EU-GMP certification for the manufacturing activity, verifiable in the EudraGMDP database.
- GACP controls documented for cultivation, harvest, drying and primary handling of the starting material.
- A Qualified Person arrangement for batch certification that the importing market accepts.
- Finished product specifications that meet the European Pharmacopoeia monograph for cannabis flower.
- Stability data that supports the shelf life claimed for the product as shipped.
- A contamination control strategy covering microbial limits, pesticides, heavy metals and foreign matter.
- Data integrity controls over electronic and paper batch records, with audit trails and defined review.
- A valid Health Canada licence and a working process for obtaining a per shipment export permit.
- Confirmation of the destination country's legal regime and its import permit before shipping.
- A mock inspection and CAPA log completed within the last twelve months.
Common Mistakes to Avoid
The first mistake is assuming a Canadian licence and Good Production Practices are enough for Europe. They are the foundation, but EU pharmacy supply adds EU-GMP, GACP and Qualified Person release on top. The second is waiting for a buyer before starting certification, which can take many months and cannot be rushed once an order is on the table. The third is thin documentation: Health Canada's own cannabis inspection data shows documentation and record keeping among the most common findings, and European inspectors apply the same lens. Writing SOPs that actually pass an inspection is not busywork, it is the evidence base buyers rely on. The fourth is treating drying and post harvest handling as outside the quality system, when European buyers treat them as part of GACP.
Frequently Asked Questions
Is the Netherlands stopping all medical cannabis exports?
The Dutch state is ending direct international exports run through its Office of Medicinal Cannabis by the end of 2026 and moving to an import based model over 2027 and 2028. Foreign orders are being routed through the licensed producer in the near term. The direction is a clear reduction of the Netherlands as an export source, which is why European buyers are looking to qualify new suppliers.
Can Canadian producers export medical cannabis to Europe?
Yes, with the right credentials. A producer needs a Health Canada licence, a per shipment export permit, and an import permit from the destination country. To supply European pharmacies, the product must be made to EU-GMP, use GACP compliant starting material, and be released by a Qualified Person. The certification, not the export permit alone, is usually the limiting step.
What is the difference between EU-GMP and GACP?
EU-GMP governs manufacturing, processing, testing and batch release of the finished medicinal product and is verified by a competent authority inspection. GACP governs the growing, harvesting and drying of the plant before it reaches the manufacturing site. European market access needs both, because contamination and consistency problems created in the field cannot be corrected later by good manufacturing.
How long does EU-GMP certification take?
It varies by site, but most producers should plan for many months of preparation before an inspection, followed by the inspection and any corrective actions. The work includes building or upgrading the pharmaceutical quality system, qualifying equipment and utilities, validating processes and methods, and generating stability data. This is why starting before a buyer appears is the practical advantage.
Does Germany's 2024 reform make exporting easier?
It made prescribing and access easier, which grew demand, but it did not lower the pharmaceutical quality requirements for imported product. Flower must still meet the European Pharmacopoeia monograph and be released by a Qualified Person. The commercial opportunity is larger, and the quality bar to reach it is unchanged.
What should a producer do first to pursue the European opening?
Start with a gap assessment against EU-GMP and GACP so you know exactly where your site stands. Use it to build a realistic plan and timeline, then close the gaps, run a mock inspection, and prepare the batch release and documentation package buyers will ask to see. A clear, evidence backed readiness position is what turns the Dutch supply gap into a contract.
How MFLRC Can Help
MF License and Regulatory Consultants works with Canadian cannabis producers on exactly this transition. Our cannabis and hemp regulatory support includes EU-GMP and GACP gap assessments, SOP and quality system development, Qualified Person Approved Quality Assurance Person support, and mock inspections that prepare you for a competent authority visit. Our regulatory affairs, licensing and import or export services cover licence strategy and export permit support, and our audit services give you the inspection readiness and CAPA discipline European buyers expect. We help you move from Canadian baseline compliance to a defensible European market position.
Planning to supply the European Union as Dutch exports contract? Book an EU-GMP readiness assessment with MFLRC and find out exactly what stands between your site and a European pharmacy shelf.
Conclusion
The Netherlands stepping back from cannabis exports is more than a piece of European news. It is a structural change in how medical cannabis supply flows across the continent, and it lands at a moment when demand is still rising. European buyers will replace Dutch supply with the next certified source they can trust. For Canadian producers, the question is simple: when a buyer comes looking, will your EU-GMP and GACP position let you say yes, or will certification still be on your to do list? The producers who prepare now will own the opening. The ones who wait will read about it.
Sources and References
- Health Canada, Import and export of cannabis by licence holders under the Cannabis Regulations
- European Commission, EudraLex Volume 4, Good Manufacturing Practice guidelines
- European Medicines Agency, Herbal medicinal products and Good Agricultural and Collection Practice
- StratCann, Bedrocan files for suspension of payments amid Dutch medical cannabis policy shift, 30 September 2026
- StratCann, Green Karat secures EU-GMP certification for international expansion, October 2026
Downloadable Resource
EU Market Access Readiness Checklist for Canadian Cannabis Producers
A practical one page checklist covering EU-GMP, GACP, Qualified Person batch release, export permits and the documentation European buyers ask for. Use it to gauge how close your site is to supplying Europe.
File: MFLRC-EU-Market-Access-Checklist.pdf
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