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 has formally challenged if the practices commonly used by importers of medical cannabis actually comply with EU GMP, the standard that pharmaceutical manufacturers must meet to be able to sell medicine 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.
According to the interpretation of the law by the authorities, medical cannabis flowers can either lose or gain their GACP status in transit and during processing. Or they may retain the GACP but it cannot be proved that the quality was not affected. To ensure that flowers remain compliant, GMPs must be followed from harvest.
Interpretation by the HLfGP could be a major influence in Germany, not only in Hessen. It may also open up the possibility of further crackdowns in other parts of the EU.
What is in the New Guidance?
Drying is a key issue for the HLfGP. In its guidance, it states that ‘ drying under controlled conditions must be regarded as a Critical Manufacturing Step With a significant impact on the quality of the product. The associated parameters, therefore, are regarded as critical process parameters.
The EU GMP Guide, continues the guide, allows cutting and, in certain circumstances, primary drying, under GACP.
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.’
The cannabis flowers either lose the GACP status in transit or during processing. Or they keep it, but can’t prove that their quality hasn’t been compromised. GMP was therefore required from harvest.
Kai-Friedrich Niermann a German expert on cannabis law and a leading German cannabis lawyer, said MEDCAN24: It is stated explicitly that GACP-compliant flower cannot be stored for long periods, transported to other countries, or imported without any quality loss.
Reprocessing
The HLfGP categorizes techniques to reduce microbiological loading, including irradiation as reprocessing in Chapter 5, Section 567 of EU GMP guide.
Niermann emphasizes that this document clearly states: “Further treatment is possible only in exceptional circumstances and should be performed in strict accordance with guidelines, as well following an extensive risk assessment.”
The HLfGP specifies that where such treatments are regularly applied to multiple batches they should become a part of a standardised manufacturing process rather than being applied post-factum.
It also refers to Section 5.1.8, Category B of European Pharmacopoeia (EP), as the microbiological standard. Following publication of the document, Dr. Markus Veit (Managing Director at Alphatopics and Co-Lead of DPhG Expert Group Medicinal Cannabis) wrote on LinkedIn that this specification is only applicable to oral products.
He wrote: “As the Pharmacopoeia does not contain any specific requirements and only Chapter 5.1.8 is applicable to oral products and distributors, it’s important to explain why they believe the limits specified in that chapter are appropriate.”
The new guidelines raise the issue of why operators apply oral product limits for cannabis inhaled without providing a formal explanation.
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. This may raise doubts regarding whether or not the supply chain is GACP/GMP compatible. The authority can request more documentation to confirm the storage and transport conditions.
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What does it mean to 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.'”
In response to the question of whether operators could challenge this interpretation in court, he said: “I do not see it happening right now.”
“The guidance document merely reflects the current legal situation; there is no right to ‘GMP-washing.’ Of course, the manufacturer has to comply with GACP/GMP. “Regulatory authorities can require the appropriate documentation and validations as well as risk assessments for the product to be of high quality.”
Niermann said that although the decision is applicable to Hesse licensed operators only, it could be extended to other states.
He explained that “in general, state regulatory agencies are very well-connected.”
He says that the critical attitude toward cannabis, and the administrative oversight of the medical cannabis distribution are the same across the nation. It is likely that other state regulatory agencies will follow suit and require supply chains to be certified as GACP/GMP compliant.
This interpretation is further augmented by the EU’s legal framework. Niermann states that competent authorities in other member states could ‘of course’ bring equivalent challenges against operators in their own jurisdictions.
The starting point for this is Directive 2001/83/EC establishing a Community Code relating to medicines for human consumption. In accordance with Article 46.f, the holder a manufacturing licence must follow the Good Manufacturing Practices laid down by Community law. GMP is therefore a requirement of the Directive for manufacturing 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. This framework is where the HMPC/GACP guidelines are located.
Although the HMPC GACP Guideline isn’t directly binding, the guideline reflects the present state of technology and science. The EU GMP Guideline Annex 7, which is a part of it, has a crucial role to play in this regard. This document emphasizes the fact that quality depends on many factors, including the cultivation conditions, harvesting methods, and the primary processing. It explicitly references the HMPC-GACP guidelines.”
Niermann concludes that the implications of GMP processing across Europe may be substantial. While this doesn’t transform GACP directly into a legally binding norm, it becomes an integral component of the European Quality Assurance System for Herbal Medicine Products.
Arthur de Cordova from Ziel, which offers Radio Frequency decontamination technologies to European cannabis producers, claims that the reading of the market is very clear. ‘We believe the third-party processing game is at the tail end of the curve, and on borrowed time.’
In Europe’s biggest medical cannabis market, the compliance model, which has been the basis of the EU cannabis import trade, GMP processing at EU point, and GACP at origin, is currently under regulatory review.
It is unclear whether the HLfGP interpretation will remain confined to Hesse or extend beyond German and Hessian borders. Cannabis as a medical treatment is becoming increasingly restricted in the EU. This long-established and controversial practice may soon be brought to an end.
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.
The Hessian State Office for Health and Care in Germany (HLfGP), has formally questioned whether practices widely used by medical marijuana importers meet EU GMP standards, which are the requirements pharmaceutical manufacturers have to satisfy before they can sell their medicines within 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.
According to the interpretation of the law by the authorities, medical cannabis flowers can either lose or gain their GACP status in transit and during processing. Or they may retain the GACP but it cannot be proved that the quality was not affected. To ensure that flowers remain compliant, GMPs must be followed from harvest.
Interpretation by the HLfGP could be a major influence in Germany, not only in Hessen. It may also open up the possibility of further crackdowns in other parts of the EU.
What is in the New Guidance?
Drying is a key issue for the HLfGP. In its guidance, it states that ‘ drying under controlled conditions must be regarded as a Critical Manufacturing Step With a significant impact on the quality of the product. In this way, they are considered to be critical parameters.
The EU GMP Guide, continues the guide, allows cutting and, in certain circumstances, primary drying, under GACP.
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 lose their GACP classification during transport and processing or, they can retain it, but still be deemed to have lost quality. GMP was therefore required from harvest.
Kai-Friedrich Niermann is a leading German Cannabis lawyer and expert in legal matters. MEDCAN24: It is stated explicitly that GACP-compliant flower cannot be stored for long periods, imported or further processed.
Reprocessing
The HLfGP categorizes techniques to reduce microbiological loading, including irradiation as reprocessing in Chapter 5, Section 567 of EU GMP guide.
Niermann says that “Further treatment is only allowed in rare cases, and it must follow strict guidelines as well as a thorough risk assessment.” The document makes this clear.
The HLfGP says that if such treatments are applied routinely across several batches, they should be part of a validated standard manufacturing procedure, and not applied afterwards.
It also refers to Section 5.1.8, Category B of European Pharmacopoeia (EP), as the microbiological standard. After publication on LinkedIn, Dr. Markus Veit of Alphatopics, Managing director of the DPhG Expert Group for Medicinal Cannabis and co-leader of that group, pointed out that these specifications only apply to oral products.
As there are no requirements in the Pharmacopoeia, and as Chapter 5.1.8 only applies to orally administered products, it is also necessary to justify why the distributors’ and QPs’ limit values therein were deemed appropriate.
Inhaling cannabis is not allowed to exceed the oral limits set by operators. This issue has been raised in the guidance, but there are no answers.
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. This may raise doubts regarding whether or not the supply chain is GACP/GMP compatible. The authority can request more documentation to confirm the storage and transport conditions.
READ MORE…
What does it mean to 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.'”
In response to the question of whether operators could challenge this interpretation in court, he said: “I do not see it happening right now.”
“The guidance document merely reflects the current legal situation; there is no right to ‘GMP-washing.’ Of course, the manufacturer has to comply with GACP/GMP. “Regulatory authorities can require the appropriate documentation and validations as well as risk assessments for the product to be of high quality.”
Niermann said that although the decision is applicable to Hesse licensed operators only, it could be extended to other states.
He explained that “in general, state regulatory agencies are very well-connected.”
He says that the critical attitude toward cannabis, and the administrative oversight of the medical cannabis distribution are the same across the nation. It is likely that other state regulatory agencies will follow suit and require supply chains to be certified as GACP/GMP compliant.
This interpretation is further augmented by the EU’s legal framework. Niermann states that competent authorities in other member states could ‘of course’ bring equivalent challenges against operators in their own jurisdictions.
The starting point for this is Directive 2001/83/EC establishing a Community Code relating to medicines for human consumption. According to Article 46 (f), holders of manufacturing authorizations must adhere to the guidelines and principles of Good Manufacturing Practice as laid out in the Community Law. GMP has been established as a legal requirement in the Directive.
Article 47 of the same directive authorises the Commission to specify these requirements through EudraLex Volume 4 – the EU GMP guide currently in force. This framework is where the HMPC/GACP guidelines are located.
Although the HMPC/GACP Guideline isn’t directly binding, the guideline is viewed as a reflection of current science and technologies. The EU GMP Guideline Annex 7, which is a part of it, has a crucial role to play in this regard. This document emphasizes the fact that quality depends on many factors, including the cultivation conditions, harvesting methods, and the primary processing. It explicitly references the HMPC guideline.”
Niermann concludes that the implications of GMP processing across Europe may be substantial. While this doesn’t transform GACP directly into a legally binding norm, it becomes a part of the European system for quality assurance in herbal medicines.
Arthur de Cordova from Ziel, which offers Radio Frequency decontamination technologies to European cannabis producers, claims that the reading of the market is very clear. ‘We believe the third-party processing game is at the tail end of the curve, and on borrowed time.’
In Europe’s biggest medical cannabis market, the compliance model, which has been the basis of the EU cannabis import trade, GMP processing at EU point, and GACP at origin, is currently under regulatory review.
It is unclear whether the HLfGP interpretation will remain confined to Hesse or extend beyond German and Hessian borders. As regulations for cannabis-as-medicine continue to be tightened across Europe, the longstanding and controversial practice of using marijuana as medicine could face an end.
Cannabis Law Resources in Poland
Browse essential legal pages on cannabis sales and cultivation in Poland. You will be guided through the process of obtaining permissions, certifications, or compliance.
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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