"GMP Washing" and Germany's Drying Rule: What Canadian Cannabis Exporters Must Do Now

Executive summary

On 8 June 2026, Germany's Hessian State Office for Health and Care (HLfGP) published a guidance document (a Merkblatt) stating that the controlled drying of cannabis flower is a critical manufacturing step and therefore falls within EU-GMP, not the lighter Good Agricultural and Collection Practice (GACP) standard that governs cultivation. The authority added that it is not aware of any validated process proving that GACP flower can be shipped, stored, imported, and processed over long distances without loss of quality. The practical message is blunt: GMP should apply from the point of harvest, and the long-standing practice of GMP washing does not create compliance that was never there.

The stakes are large. Germany imported 50,539 kg of medical cannabis in the first quarter of 2026, and more than 218 tonnes across a rolling twelve-month window, with Canada the single largest supplier at roughly 53 percent of flower. Canadian exporters who rely on third-party EU processing now face a documentation and validation test they may not pass. The fix is a properly evidenced GACP-to-GMP supply chain, a defensible drying and processing validation package, and a Qualified Person who can release each batch with confidence.

What is "GMP washing," and why did Germany act?

Direct answer: "GMP washing" is the practice of importing cannabis flower that was grown under GACP and then routing it through an EU-GMP certified facility so the finished product carries a GMP certificate the original material never earned at source. Germany's Hesse authority acted because it concluded that drying and other post-harvest steps materially change product quality, so applying GMP only after the fact does not prove the product was made to GMP standards.

For years, the economics of medical cannabis in Europe rested on a split. Cultivators in Canada, Portugal, and elsewhere grew flower under GACP, the EMA-recognized standard for starting materials of herbal origin. The flower was then shipped to an EU-GMP processor that dried, trimmed, decontaminated, tested, packaged, and released it as a finished medicinal product. On paper, the finished product held EU-GMP certification. In practice, some of the steps that most affect quality, including drying and microbial control, may have happened before GMP oversight ever began.

The HLfGP guidance challenges the legal foundation of that arrangement. It states that drying under controlled conditions must be regarded as a critical manufacturing step with a decisive influence on product quality, which means its parameters are critical process parameters that belong under GMP control. The authority also said it is not aware of any process that has demonstrably shown that GACP flower can be transported, stored, imported, and further processed over long distances without any loss of quality. The logic that follows is difficult to escape: either the flower loses its GACP status in transit, or it keeps that status but cannot be proven to arrive intact, so GMP should have applied from harvest.

For background on the two frameworks and where each applies, MFLRC's overview of why EU-GMP compliance matters for cannabis is a useful companion to this article.

GACP vs EU-GMP: who is responsible for each production step?

Direct answer: GACP governs cultivation and the earliest primary processing, while EU-GMP governs the manufacturing steps that shape the medicinal product. The dispute in Germany is precisely about drying and trimming, which sit at the boundary. Under the new interpretation, controlled drying moves firmly onto the GMP side of the line.

The EU framework for herbal medicinal products, set out in Annex 7 of the EU-GMP Guide (EudraLex Volume 4), recognizes that cultivation, collection, and some primary processing may occur under GACP, while the manufacture of the medicinal product falls under GMP. The boundary was always a judgement call, and cannabis exporters read it generously. The HLfGP has now read it narrowly for the step that matters most. The table below maps common production steps to the responsible standard, first under the traditional reading and then under Germany's 2026 interpretation.

The shift in the primary drying and trimming rows is the entire story. If you are a Canadian cultivator who dries and trims under GACP and expects a European processor to supply the GMP, Germany is now telling you that the GMP evidence has to exist for those steps too. For a deeper look at how the standards differ in practice, see MFLRC's guide on EU-GMP vs GPP and choosing the right standard, and the primer on what a cannabis cultivator should know.

Why this hits Canadian exporters hardest

Direct answer: Canada supplies the largest share of Germany's medical cannabis flower, and much of it reaches patients through the GACP-at-source, GMP-in-Europe model that the HLfGP is now questioning. When the compliance basis of that model is challenged, Canadian volume is the most exposed.

The numbers make the exposure concrete. According to Germany's Federal Institute for Drugs and Medical Devices (BfArM), Germany imported 50,539 kg of medical cannabis in the first quarter of 2026, and more than 218 tonnes over a rolling twelve-month period. Canada was the largest single supplier, shipping roughly 26,753 kg, about 53 percent of the flower, with Portugal second at around 10,342 kg as Europe's main processing hub. A rule that raises the evidentiary bar for imported, third-party-processed flower lands directly on the country that ships the most of it.

This is not a theoretical risk. In 2025, the Canadian company Mera Cannabis Corp. was issued a Statement of Non-Compliance with EU-GMP by the Berlin State Office for Health and Social Affairs (LAGeSo) after an inspection produced ten major findings. Among the eight key issues was the purchase of dried cannabis flowers from non-GMP facilities, alongside gaps in environmental monitoring, stability studies, document control, and data integrity. Reporting at the time noted it appeared to be the first time an EU regulator had cited purchase from non-GMP facilities as a concern. The company lost its EU-GMP certification. That case shows how a supply chain weakness, rather than a single product defect, is enough to end market access.

There is also a jurisdictional multiplier. Pharmaceutical supervision in Germany is decentralized, so each federal state runs its own inspections and can adopt its own interpretation. Legal experts expect other state authorities to follow Hesse's lead, and note that competent authorities in other EU member states could bring equivalent challenges under Directive 2001/83/EC. A problem that starts in one state rarely stays there.

What actually changed in the June 2026 guidance

Direct answer: The HLfGP guidance reclassifies controlled drying as a GMP critical step, tightens the treatment of decontamination as reprocessing, and requires every import application to include a diagram showing which facility performed which step and under which standard. It converts a tolerated grey area into a documented, inspectable expectation.

First, drying is now framed as a critical manufacturing step with critical process parameters. That language is deliberate. In GMP, critical process parameters must be defined, controlled, monitored, and validated. Saying the flower was dried is no longer enough. You need evidence of how it was dried, within what limits, and how those limits were verified.

Second, techniques used to reduce microbiological load, including irradiation, are classified by the HLfGP as reprocessing under Chapter 5 of the EU-GMP Guide (the guidance cites Section 5.67). Reprocessing is permitted only in exceptional cases, under strictly defined conditions and following a comprehensive risk assessment. Where such treatments are applied routinely across batches, the guidance says they must become part of the validated standard manufacturing process rather than an after-the-fact rescue. The guidance also points to Category B of European Pharmacopoeia Section 5.1.8 as a microbiological reference, while experts have noted that this section applies to oral products, so applying those limits to inhaled cannabis requires its own justification.

Third, and most practical, page 3 of the Merkblatt requires that every application submitted to the authority include a diagram clarifying at which facility, by which supplier, and under which conditions (GACP or GMP) each process step was carried out. If that diagram raises doubts, the authority may request additional documentation to validate transport and storage conditions. Responsibility for the whole chain rests with the Qualified Person who releases each batch under Germany's Medicines Act, regardless of whether GMP formally applied in the country where a step took place. In other words, the QP cannot outsource accountability to a foreign cultivator's paperwork.

For companies mapping the full pathway from Canadian cultivation to EU release, MFLRC's EU-GMP and GACP certification roadmap for Canada and Germany sets out the sequence in detail, and the Good Production Practices (GPP) overview explains how Canada's domestic baseline relates to these EU expectations.

The practical path to compliance

Direct answer: Canadian exporters should map their supply chain against the new drying and processing expectations, build or strengthen the validation evidence for drying and decontamination, and give their Qualified Person a defensible, document-backed release package. The goal is to prove quality was built in from harvest, not stamped on later.

Start with a gap assessment that treats drying and trimming as GMP steps. Look at where each step physically happens, who performs it, and what evidence exists that the step was controlled. If drying happens in Canada under GACP, decide whether to bring it under GMP or to generate the validation and transport data needed to defend the current split. MFLRC runs these assessments against the specific state expectations your product will meet.

Next, build the drying and processing validation package. Define critical process parameters for drying, including temperature, humidity, airflow, moisture endpoint, and time, and validate that your process holds those parameters within limits. Do the same for decontamination if you use it, and treat it as part of the validated process rather than an exception. This is the single most important technical response to the new guidance.

Third, construct the supply chain diagram the authority now expects. Document every facility, supplier, and standard (GACP or GMP) for every step, plus transport and storage conditions between them. If you cannot draw this diagram cleanly today, you are not import-ready under the new rule.

Fourth, strengthen the quality management system that holds it together. That means SOPs for post-harvest processing, environmental monitoring, stability data, document and data integrity controls, and a CAPA system that can respond to findings before an inspector does. The Mera case is a reminder that document control and data integrity failures sink certifications as surely as product defects.

Finally, run a mock audit against the exact scenario a state inspector or a buyer's QP will apply. Rehearse the questions, test the diagram, and fix the gaps while they are still cheap to fix. MFLRC delivers all of these: gap assessment, drying and processing validation, QMS build, SOP development, EU-GMP certification support, GACP compliance, and mock audits.

Compliance checklist for Germany-bound cannabis

Use this as a pre-export readiness check. If you cannot answer yes, with evidence, to each item, treat it as an open gap.

• We have mapped every production step from propagation to release and assigned each to GACP or GMP.
• Drying is defined with critical process parameters and those parameters are validated.
• Trimming and any size reduction are documented and controlled to quality standards.
• Any decontamination or irradiation is part of the validated standard process, with a risk assessment on file.
• Our microbiological specification is justified for the intended route of administration (inhaled vs oral).
• We can produce a clear supply chain diagram showing facility, supplier, and standard for each step.
• Transport and storage conditions between facilities are documented and defensible.
• Stability data supports the shelf life and storage claims for the finished product.
• Environmental monitoring is calibrated, validated, and recorded.
• Document control and data integrity controls meet EU-GMP expectations.
• Our Qualified Person has a complete, evidence-backed package to release each batch.
• A recent gap assessment or mock audit confirms readiness against the current German interpretation.

Common mistakes to avoid

• Treating GACP as a complete export credential. GACP covers cultivation. It does not, on its own, satisfy Germany's expectation that drying is controlled to GMP standards.
• Assuming the EU processor's certificate covers you. A downstream GMP stamp does not retroactively prove that upstream drying and trimming were done to standard. The QP still needs the evidence.
• Leaving drying parameters undefined. Dried to industry norms is not a validated process. Undefined critical process parameters are among the easiest findings for an inspector to write.
• Using decontamination as a routine rescue. Applying irradiation batch after batch, outside the validated process, is exactly the reprocessing pattern the guidance targets.
• Borrowing oral microbiological limits without justification. European Pharmacopoeia 5.1.8 Category B was written for oral use, and applying it to inhaled cannabis needs a documented rationale.
• Being unable to draw the supply chain diagram. If facility, supplier, and standard cannot be shown cleanly for every step, the application is incomplete before it is even reviewed.
• Waiting for your state to enforce before acting. Supervision is decentralized and interpretations spread between states. The safe assumption is that this expectation is coming to your buyer's jurisdiction.

Frequently asked questions

What is "GMP washing" in cannabis?

GMP washing is the practice of importing cannabis flower grown under GACP and routing it through an EU-GMP certified facility so the finished product carries a GMP certificate the original material did not earn at source. Germany's Hesse authority now argues this does not create compliance that was absent from the start, because drying and other post-harvest steps affect quality.

Is GACP-only cannabis still accepted for export to Germany?

Not reliably for the drying step. As of the 8 June 2026 HLfGP guidance, controlled drying is treated as a GMP critical step. GACP still governs cultivation, but exporters now need GMP-grade evidence that drying and trimming were controlled, or they risk having applications questioned.

Do I need an EU-GMP certificate to dry cannabis for the German market?

Germany's Hesse authority states that a valid GMP certificate must cover the drying step for flower destined for patients. If drying happens abroad under GACP, you need validated, defensible evidence that quality was not lost, which in practice pushes drying toward GMP-certified conditions.

What exactly did the HLfGP change on 8 June 2026?

The HLfGP published a guidance document (Merkblatt) reclassifying controlled drying as a critical manufacturing step under GMP, tightening the treatment of decontamination as reprocessing, and requiring every import application to include a diagram showing which facility performed which step under which standard (GACP or GMP).

Who is legally responsible for the whole supply chain?

Under Germany's Medicines Act, the Qualified Person who releases each batch is responsible, even for steps performed outside GMP jurisdiction in another country. The QP must hold documentation, validations, and risk assessments proving a compliant GACP-to-GMP chain.

Will this spread beyond Hesse?

Very likely. German pharmaceutical supervision is decentralized, and legal experts expect other state authorities to adopt the same interpretation. Because the underlying basis is EU Directive 2001/83/EC and the EU-GMP Guide, authorities in other member states could raise equivalent challenges.

How MFLRC can help

MFLRC is a Canadian regulatory and quality consultancy with deep experience across cannabis, pharmaceuticals, natural health products, and medical devices. We help Canadian licensed producers and processors keep their access to Germany and the wider EU as the compliance bar rises.

Our support for exporters facing the new drying rule includes gap assessments against the current German and EU-GMP interpretation, drying and post-harvest processing validation, decontamination process validation, quality management system builds, SOP development, EU-GMP certification support, GACP compliance, and mock audits that rehearse the exact scrutiny a state inspector or a buyer's Qualified Person will apply. We translate a fast-moving regulatory signal into a defensible, document-backed export file.

If you export cannabis to Germany, or plan to, the time to test your drying and processing chain is before a buyer or an authority does it for you. Contact MFLRC for a consultation and a gap assessment roadmap tailored to your systems and your target markets.

Conclusion

Germany did not pass a new law on 8 June 2026. It published an interpretation, and interpretation can be enough. By treating drying as a manufacturing step, the HLfGP reframed the compliance model that carries most of Canada's flower into Europe. The exporters who thrive from here will be the ones who can prove, step by step, that quality was built in from harvest rather than certified after the fact. That proof is buildable, but it takes a validated process, a clean supply chain diagram, and a Qualified Person with the evidence to stand behind every batch. The producers who start now will still be shipping when the practice of GMP washing runs out of road.

Sources and references

• Business of Cannabis, "No Right to GMP Washing: German State Challenges Cannabis Flower Import Compliance" (8 July 2026), reporting the HLfGP Merkblatt of 8 June 2026.
• StratCann, "Germany's BfArM clarifies cultivar approval as EU-GMP scrutiny increases" (19 November 2025), including the Mera Cannabis Statement of Non-Compliance.
• European Commission, EudraLex Volume 4, EU-GMP Guide (Annex 7 and Chapter 5).
• European Medicines Agency, Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin.
• Directive 2001/83/EC (Community code relating to medicinal products for human use), Articles 46(f) and 47. BfArM medical cannabis import data for Q1 2026 (50,539 kg; 218 tonnes rolling; Canada approximately 53 percent) as reported by industry trade press. Verify current figures with BfArM directly before relying on them for a regulatory submission.