This report from the Business of Cannabis, published 6 July 2026
Germany’s Hessian State Office for Health and Care (HLfGP) has formally challenged whether the practices broadly used by medical cannabis importers actually meet EU GMP requirements, the standard pharmaceutical manufacturers must satisfy to sell medicines in the EU.
A ‘guidance document’ (Merkblatt) published by the HLfGP on June 08, targets the widespread practice of importing cannabis flowers from third-country cultivators under Good Agricultural and Collection Practice (GACP) certification before processing them at EU-based GMP facilities.
In a nutshell, the authority’s reading of the law is that medical cannabis flowers either lose their GACP status during transit and processing, or they retain it but cannot reliably be proven to arrive without a loss of quality. Therefore, in order for flowers to remain compliant GMP must be applied from the point of harvest.
The HLfGP’s interpretation could have a significant import across the German state, not just in Hessen, and open the door for further crackdowns elsewhere in the EU.
What’s in the new guidance?
A central point of contention for the HLfGP is the drying phase. In its guidance, it states that ‘ drying under controlled conditions must be regarded as a critical manufacturing step with a decisive influence on product quality. Accordingly, the associated parameters are considered critical process parameters.’
Annex 7 of the EU GMP guide, it continues, permits cutting and in some circumstances primary drying under GACP conditions.
It states explicitly that it is ‘not aware of any process that has demonstrably shown that flowers which can still legitimately be regarded as GACP flowers can be transported, stored, imported and further processed over long distances without any loss of quality.’
Cannabis flowers, therefore, either lose their GACP status during transit and processing, or they retain it but cannot be proven to arrive without quality loss. As such, GMP should have applied from the point of harvest.
Leading German cannabis lawyer and legal expert Kai-Friedrich Niermann, told Business of Cannabis: “The authority explicitly notes that GACP-compliant flowers cannot be transported over long distances, stored, imported, or further processed without any loss of quality.”
Reprocessing
Techniques used to reduce microbiological load, including irradiation, are classified by the HLfGP as reprocessing under Chapter 5, Section 5.67 of the EU GMP guide.
“Further processing is only possible in exceptional cases and must be carried out in accordance with strictly defined guidelines and following a comprehensive risk assessment,” Niermann states, pointing out that the document is explicit.
Where such treatments are routinely applied across multiple batches, the HLfGP states they must become part of the validated standard manufacturing process, rather than applied after the fact.
The document also references Category B of European Pharmacopoeia Section 5.1.8 as the applicable microbiological standard. Writing on LinkedIn following publication, Dr. Markus Veit, Managing Director of Alphatopics and co-lead of the DPhG Expert Group on Medicinal Cannabis, flagged that this specification applies to oral products only.
“As there is no specific requirement in the Pharmacopoeia and Chapter 5.1.8 applies only to oral products, this also requires justification as to why distributors and their QPs consider the limit values specified there to be appropriate,” he wrote.
Operators applying oral product limits to inhaled cannabis have been doing so without formally justifying why those limits are appropriate for inhalation, an issue the new guidance raises but offers no solutions to.
The document explicitly states that some process steps critical to GMP compliance are carried out outside of GMP-certified facilities, a responsibility that falls on the Qualified Person under §14 of Germany’s Medicines Act, the individual who releases each batch for sale, regardless of whether GMP requirements apply in the country where those steps took place.
“The key point is the note on page 3,” Niermann says, “which states that every application submitted to the HLfGP must be accompanied by a diagram clarifying at which facility, by which supplier, and under which conditions – GACP or GMP – specific process steps were carried out. Should this give rise to doubts as to whether this information can demonstrate a GACP/GMP-compliant supply chain, the authority may request additional documentation to validate the transport and storage conditions.”
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