Germany Puts “GMP Washing” in Medical Cannabis on Notice

BERLIN – Germany’s Hessian State Office for Health and Care (HLfGP) published a formal guidance document targeting the widespread practice of “GMP washing”, i.e. importing Cannabis flowers from third-country cultivators under Good Agricultural and Collection Practice (GACP) certification, then running them through EU-based GMP facilities before supplying the German market.

At the center of the HLfGP’s position is a single claim. The authority stated it was unaware of any validated process showing that GACP-grown Cannabis flower can be shipped long distances and later processed under EU-GMP without quality loss.

The drying step is the document’s focal point. The guidance states that controlled drying is a critical manufacturing step that directly affects product quality and is therefore subject to GMP requirements, applying regardless of other circumstances. Annex 7 of the EU-GMP Guide permits cutting and primary drying under GACP conditions in certain circumstances, but the Hessian authority’s position is that this cannot be reliably validated across long-haul international transport routes. Under its reading, GMP must apply from the point of harvest, not at a downstream EU processing facility.

The document also addresses decontamination. Techniques used to reduce microbiological load, including irradiation, are classified as reprocessing under Chapter 5, Section 5.67 of the EU-GMP Guide. Where such treatments are routinely applied across multiple batches, the HLfGP states they must become part of the validated standard manufacturing process, not applied after the fact.

Kai-Friedrich Niermann, a leading German Cannabis lawyer, noted the document simply codifies existing law. “There is no right to GMP washing,” he said, adding that regulatory authorities are fully entitled to require appropriate documentation, validations, and risk assessments to ensure pharmaceutical product quality. He characterized the chances of operators successfully contesting the guidance as remote.

The Merkblatt, an information sheet rather than a binding regulation, applies directly to Hesse-licensed operators. Niermann noted that German state pharmaceutical authorities are closely networked and that additional states are likely to adopt the same approach, requiring GACP/GMP-compliant supply chain certification. He added that competent authorities in other EU member states could bring equivalent challenges under Directive 2001/83/EC, Article 46(f), which establishes GMP as mandatory for any holder of a pharmaceutical manufacturing authorization, with the specifics detailed in EudraLex Volume 4.

Industry response has been direct. Arthur de Cordova of Ziel, which supplies radio frequency decontamination technology to European Сannabis operators, stated the third-party processing model is at the tail end of the curve and on borrowed time. Australia-listed ECS Botanics similarly characterized the guidance as a positive signal for integrated GMP producers, citing potential for a narrowing pool of compliant product and upward pricing pressure for those that qualify.

Germany accounts for an estimated 40–50% of EU medical Cannabis imports by value. Canada alone supplied nearly half of the country’s total import volume in 2025. If HLfGP’s interpretation takes hold across German states and broader EU jurisdictions, a scenario legal experts describe as plausible, the compliance model that has underpinned the bulk of that trade for years faces a structural reckoning. Exporters from Canada, Australia, South Africa, and elsewhere who built GMP certification into cultivation and drying from the start carry a durable market advantage. Those who relied on last-mile EU processing to meet the standard will face a substantial rebuild of their access infrastructure for a market that, by any measure, is the one that matters most in Europe.