Authorities from the German state of Hesse have taken aim at the practice of ‘GMP washing’ in its thriving medical cannabis market, an intervention that could have significant implications for the industry at large.
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 MEDCAN24: “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.”
READ MORE…
What does this mean for operators?
The Merkblatt‘s status as an information sheet rather than a formal regulation raises the question of whether Hesse-licensed operators are legally obliged to comply, or whether they could contest it.
According to Neirmann, “In this guidance document, the Hessian authority has outlined how it will interpret the existing regulations governing the import of medical cannabis,” he says. “The Hessian authority aims to address the current problem of ‘GMP washing.’”
On whether operators can challenge this interpretation legally, he added: “I don’t see that happening at the moment.
“The guidance document merely reflects the current legal situation; there is no right to ‘GMP-washing.’ It goes without saying that the manufacturer must maintain a GACP/GMP-compliant supply chain. Regulatory authorities are fully within their rights to require appropriate documentation, validations, and risk assessments to ensure the quality of the pharmaceutical product.”
The ruling applies directly to Hesse-licensed operators, but Niermann says it has the potential to spread across other states.
“In general, the state regulatory authorities are well connected with one another,” he explained.
“The critical stance toward cannabis and the bureaucratic oversight of the distribution of medical cannabis are similar across the country,” he says. “It can be assumed that additional state regulatory authorities will adopt this approach and will also require schemes that certify supply chains as compliant with GACP/GMP.”
The EU legal basis extends the interpretation’s potential reach further still. Niermann states that competent authorities in other member states could ‘of course’ bring equivalent challenges against operators in their own jurisdictions.
“The starting point is Directive 2001/83/EC establishing a Community code relating to medicinal products for human use. Pursuant to Article 46(f), the holder of a manufacturing authorisation must comply with the principles and guidelines of Good Manufacturing Practice laid down in Community law. The Directive itself thus establishes GMP as a mandatory requirement for the manufacture of medicinal products.”
Article 47 of the same directive authorises the Commission to specify these requirements through EudraLex Volume 4 – the EU GMP guide currently in force. The HMPC-GACP guideline sits within that framework.
“Although the HMPC-GACP guideline is not directly binding, it is regarded as reflecting the current state of science and technology. Annex 7 of the EU GMP guideline is of crucial importance in this context. It explicitly emphasises that the quality of herbal raw materials depends significantly on the conditions of cultivation, harvesting, and primary processing. The guidance explicitly refers to the HMPC-GACP guideline.”
In conclusion, Niermann believes the knock-on implications for GMP processors across Europe could be significant. “While this does not transform GACP into a directly binding legal norm, the guideline effectively becomes an integral part of the European quality assurance system for herbal medicinal products.”
Arthur de Cordova of Ziel, which supplies Radio Frequency decontamination technology to European cannabis operators, says the market read is clear. ‘We believe the third-party processing game is at the tail end of the curve, and on borrowed time.’
The compliance model that has underpinned the EU cannabis flower import trade for years, GACP at source, GMP at the point of EU processing, is now under formal regulatory scrutiny in Europe’s largest medical cannabis market.
Whether the HLfGP’s interpretation remains contained to Hesse, or spreads beyond Hessian and German borders remains unclear. But, as regulations relating to cannabis as a medicine continue to tighten across the EU, this long established and controversial practice could soon face a reckoning.
Authorities from the German state of Hesse have taken aim at the practice of ‘GMP washing’ in its thriving medical cannabis market, an intervention that could have significant implications for the industry at large.
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 MEDCAN24: “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.”
READ MORE…
What does this mean for operators?
The Merkblatt‘s status as an information sheet rather than a formal regulation raises the question of whether Hesse-licensed operators are legally obliged to comply, or whether they could contest it.
According to Neirmann, “In this guidance document, the Hessian authority has outlined how it will interpret the existing regulations governing the import of medical cannabis,” he says. “The Hessian authority aims to address the current problem of ‘GMP washing.’”
On whether operators can challenge this interpretation legally, he added: “I don’t see that happening at the moment.
“The guidance document merely reflects the current legal situation; there is no right to ‘GMP-washing.’ It goes without saying that the manufacturer must maintain a GACP/GMP-compliant supply chain. Regulatory authorities are fully within their rights to require appropriate documentation, validations, and risk assessments to ensure the quality of the pharmaceutical product.”
The ruling applies directly to Hesse-licensed operators, but Niermann says it has the potential to spread across other states.
“In general, the state regulatory authorities are well connected with one another,” he explained.
“The critical stance toward cannabis and the bureaucratic oversight of the distribution of medical cannabis are similar across the country,” he says. “It can be assumed that additional state regulatory authorities will adopt this approach and will also require schemes that certify supply chains as compliant with GACP/GMP.”
The EU legal basis extends the interpretation’s potential reach further still. Niermann states that competent authorities in other member states could ‘of course’ bring equivalent challenges against operators in their own jurisdictions.
“The starting point is Directive 2001/83/EC establishing a Community code relating to medicinal products for human use. Pursuant to Article 46(f), the holder of a manufacturing authorisation must comply with the principles and guidelines of Good Manufacturing Practice laid down in Community law. The Directive itself thus establishes GMP as a mandatory requirement for the manufacture of medicinal products.”
Article 47 of the same directive authorises the Commission to specify these requirements through EudraLex Volume 4 – the EU GMP guide currently in force. The HMPC-GACP guideline sits within that framework.
“Although the HMPC-GACP guideline is not directly binding, it is regarded as reflecting the current state of science and technology. Annex 7 of the EU GMP guideline is of crucial importance in this context. It explicitly emphasises that the quality of herbal raw materials depends significantly on the conditions of cultivation, harvesting, and primary processing. The guidance explicitly refers to the HMPC-GACP guideline.”
In conclusion, Niermann believes the knock-on implications for GMP processors across Europe could be significant. “While this does not transform GACP into a directly binding legal norm, the guideline effectively becomes an integral part of the European quality assurance system for herbal medicinal products.”
Arthur de Cordova of Ziel, which supplies Radio Frequency decontamination technology to European cannabis operators, says the market read is clear. ‘We believe the third-party processing game is at the tail end of the curve, and on borrowed time.’
The compliance model that has underpinned the EU cannabis flower import trade for years, GACP at source, GMP at the point of EU processing, is now under formal regulatory scrutiny in Europe’s largest medical cannabis market.
Whether the HLfGP’s interpretation remains contained to Hesse, or spreads beyond Hessian and German borders remains unclear. But, as regulations relating to cannabis as a medicine continue to tighten across the EU, this long established and controversial practice could soon face a reckoning.
Cannabis Law Resources in Poland
Explore essential legal pages about cannabis cultivation, sales, and medical product regulations in Poland. These resources will guide you through permissions, certifications, and compliance requirements.
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Polish News Registration and Interests of Cannabis Businesses
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Permissions for Cannabis Sales in Poland
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Authorization for Importing or Manufacturing Medical Products
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Permission for Manufacturing or Importing Medical Products
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Certificate of Good Manufacturing Practices (GMP)
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Registration of Medical Products in Poland