Cannabis flower released as medicine in Hesse must be dried and trimmed at the place the plants are harvested, the Hessian State Office for Health and Care says in a June 8 guidance letter, unless a producer can prove beyond doubt that skipping or splitting the drying causes no loss of quality.
The document treats drying under controlled conditions as a critical manufacturing step that materially affects product quality, which puts its parameters inside the GMP rules rather than the lighter GACP standard that governs cultivation (source: HLfGP Merkblatt). Annex 7 of the GMP guideline does allow coarse cutting and possibly a primary drying step under GACP conditions, but only where the work genuinely stays within those limits and the medicine’s quality is not affected. The authority says it knows of no process that has demonstrably allowed flower still classifiable as GACP material to be transported over long distances, stored, imported, and processed further without quality loss. Either the conditions for GACP flower are not met, because the handling goes beyond initial drying and coarse cutting, or the flower cannot be shown to survive extended storage and transport before later steps without degrading.
What a third country permits does not change this. The authority states that if cannabis flower is partly manufactured in a country where the GMP guideline does not apply, the guideline still has to be observed for material released and sold as medicine in Germany. Responsibility sits with the Qualified Person under the German Medicines Act who releases the flower for sale, and that responsibility holds even when partial manufacturing happens at sites in other EU states or third countries operating under different rules.
This is the mechanism that bears on EU GMP washing, the practice of converting imported flower through a European facility to obtain a certification the original material would not otherwise carry. The Hesse letter does not use that term. What it does is close the interpretive gap that lets a partial dry abroad be finished and certified in Europe, by calling the finishing dry a GMP step that cannot be laundered through a GACP origin.
The guidance also restricts reprocessing. Under chapter 5 of the EU GMP guideline, reprocessing is possible only in exceptional cases, under strictly defined conditions and a full risk assessment, and that includes any after-the-fact drying or reduction of microbial load. Batches put through such steps cannot be sold without proof of suitability and stability, and where the rework is applied to most batches it should become a validated part of the standard process.
A grower active in the supply chain, who asked not to be named, says the Hesse letter is one of two recent moves, with a second issued covering the Darmstadt district, bringing those regions into line with a stance already taken in Cologne against EU GMP washing. In this grower’s account, the districts have shut the loophole that allowed a partial dry in a country like Colombia to be finished in Germany, with Darmstadt refusing to permit that conversion within its territory.
The harder case, by this grower’s telling, is the multi-country chain. Flower partially processed in Colombia, sent to Portugal, and converted there under EU GMP is something Germany still struggles to reject outright, though a Qualified Person doing the job properly should catch it, and a chain routed through a third country this way is in the grower’s estimate roughly ninety percent not allowed. Qualified Persons carry more accountability than before, and where one checks the supply path and finds the chain invalid, the regional authority in Darmstadt would examine it.
Source:








