The Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA) published a draft opinion on July 09, open for consultation between 1 August and 31 October 2025, which concludes that no EU monograph can currently be created for Cannabis Sativa L., flos.
Following a data request in early 2023 and a comprehensive review, the HMPC said there are currently no authorised medicines in the EU made exclusively from cannabis flowers. Although some formulations exist in individual member states, none have been formally evaluated or authorised by national regulators for specific indications, strengths or dosages.
As highlighted in a LinkedIn post by industry analyst Alfredo Pascaual, the data available also does not meet the requirements for ‘established use’ or ‘traditional use,’ lacking consistency, defined quality standards and sufficient evidence of safety, efficacy and continued medical application.
Mandate restrictions also play a role, as the HMPC’s remit is limited to herbal medicinal products, with the only exceptions being stand-alone or mixed applications and products based on isolated cannabinoids. The only cannabis-based medicinal product approved in the EU remains a combination product authorised in 2011.
“The HMPC is of the opinion that it is not possible to establish a European Union herbal monograph on Cannabis Sativa L., flos, at present. In summary, no conclusions can be drawn due to the absence of medicinal products with single herbal preparations from Cannabis Sativa L., flos on the EU market,” the document reads.
The GACP system ensures that plants used in the manufacture of medicines and other products are grown and collected in accordance with strict quality and safety standards.
In line with EU directives, GACP covers the entire process of plant production and harvesting, from the choice of cultivation area and control of fertilisers and pesticides to environmentally sound practices. Post-harvest handling and storage are also regulated to safeguard purity and effectiveness.
Compliance requires full documentation from seed selection to delivery, ensuring transparency and traceability. Companies adhering to GACP are regularly audited to verify standards are met, protecting both consumer health and the environment.
The EU Guidelines on GACP for herbal raw materials were first published in 2006, and have remained largely unchanged. In 2024, however, a consultation on significant revisions was launched. The HMPC’s work plan indicates that the updated guidance is scheduled for publication in 2025, suggesting an updated GACP framework is imminent.
Industry analyst Karina Lahnakoski, who has more than 25 years’ experience in regulated industries, notes that the proposed changes are likely to have a substantial impact on cannabis businesses, particularly exporters to the EU. In her view, the revisions signal a convergence between GACP and Good Manufacturing Practice (GMP), especially for indoor and greenhouse cultivation.
Some cannabis companies have been known to use packaging processes to reclassify GACP-compliant products as GMP-compliant. Lahnakoski argues that this, in part, has driven regulators to clarify boundaries.
For the first time, the proposed guidance explicitly references ‘EudraLex Volume 4 Annex 7’ and sets out when post-harvest activities such as drying and cutting fall under GMP Part I or II. This would create a clearer line between GACP and GMP, and potentially leave the industry with significant work to implement the changes within six months of publication.
To prepare, Lahnakoski recommends companies conduct early gap analyses to identify cultivation areas requiring validation. Environmental parameters such as light, humidity, temperature and airflow should be tightly controlled and logged with calibrated monitoring systems, while irrigation water will need to meet not only local but also destination-country standards.
Documentation will become increasingly central, with standard operating procedures (SOPs) for drying, microbial decontamination, cleaning, and pest control requiring validation and detailed records. Producers may also face new obligations under written quality agreements, subjecting them to regular inspections by manufacturers or end-product companies.
Stricter oversight will extend to drying, disinfection and decontamination processes. SOPs will need to cover time, temperature and airflow, while microbial reduction methods such as irradiation or ozone treatment must be validated and justified. Fumigant restrictions are expected to tighten, requiring alternatives backed by risk assessments.
Traceability standards will also increase, with requirements for batch-level records covering seed source, cultivation area, propagation batch and harvest date. For indoor growers, this means extensive record-keeping on training, equipment, environmental conditions and staff activities.
Although the final guideline has not yet been published, Lahnakoski warns that regulators and new customers are unlikely to accept systems that are merely ‘in progress.’
Fully validated procedures and controls will be expected from day one, making early preparation critical. If adopted as currently proposed, the changes would significantly raise the compliance bar for medical cannabis producers across Europe and beyond, particularly those seeking to access the EU market.
Companies may need to reassess suppliers, renegotiate contracts, and invest in infrastructure upgrades to ensure audit readiness.
The post No EU Monograph for Cannabis Flowers Over ‘Lack of Evidence’ as New GACP Rules Loom appeared first on Business of Cannabis.
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Following a data request in early 2023 and a comprehensive review, the HMPC said there are currently no authorised medicines in the EU made exclusively from cannabis flowers. Although some formulations exist in individual member states, none have been formally evaluated or authorised by national regulators for specific indications, strengths or dosages.
As highlighted in a LinkedIn post by industry analyst Alfredo Pascaual, the data available also does not meet the requirements for ‘established use’ or ‘traditional use,’ lacking consistency, defined quality standards and sufficient evidence of safety, efficacy and continued medical application.
Mandate restrictions also play a role, as the HMPC’s remit is limited to herbal medicinal products, with the only exceptions being stand-alone or mixed applications and products based on isolated cannabinoids. The only cannabis-based medicinal product approved in the EU remains a combination product authorised in 2011.
“The HMPC is of the opinion that it is not possible to establish a European Union herbal monograph on Cannabis Sativa L., flos, at present. In summary, no conclusions can be drawn due to the absence of medicinal products with single herbal preparations from Cannabis Sativa L., flos on the EU market,” the document reads.
Good Agricultural and Collection Practices (GACP)
The GACP system ensures that plants used in the manufacture of medicines and other products are grown and collected in accordance with strict quality and safety standards.
In line with EU directives, GACP covers the entire process of plant production and harvesting, from the choice of cultivation area and control of fertilisers and pesticides to environmentally sound practices. Post-harvest handling and storage are also regulated to safeguard purity and effectiveness.
Compliance requires full documentation from seed selection to delivery, ensuring transparency and traceability. Companies adhering to GACP are regularly audited to verify standards are met, protecting both consumer health and the environment.
Changes expected in 2025
The EU Guidelines on GACP for herbal raw materials were first published in 2006, and have remained largely unchanged. In 2024, however, a consultation on significant revisions was launched. The HMPC’s work plan indicates that the updated guidance is scheduled for publication in 2025, suggesting an updated GACP framework is imminent.
Industry analyst Karina Lahnakoski, who has more than 25 years’ experience in regulated industries, notes that the proposed changes are likely to have a substantial impact on cannabis businesses, particularly exporters to the EU. In her view, the revisions signal a convergence between GACP and Good Manufacturing Practice (GMP), especially for indoor and greenhouse cultivation.
Some cannabis companies have been known to use packaging processes to reclassify GACP-compliant products as GMP-compliant. Lahnakoski argues that this, in part, has driven regulators to clarify boundaries.
For the first time, the proposed guidance explicitly references ‘EudraLex Volume 4 Annex 7’ and sets out when post-harvest activities such as drying and cutting fall under GMP Part I or II. This would create a clearer line between GACP and GMP, and potentially leave the industry with significant work to implement the changes within six months of publication.
Preparing for compliance
To prepare, Lahnakoski recommends companies conduct early gap analyses to identify cultivation areas requiring validation. Environmental parameters such as light, humidity, temperature and airflow should be tightly controlled and logged with calibrated monitoring systems, while irrigation water will need to meet not only local but also destination-country standards.
Documentation will become increasingly central, with standard operating procedures (SOPs) for drying, microbial decontamination, cleaning, and pest control requiring validation and detailed records. Producers may also face new obligations under written quality agreements, subjecting them to regular inspections by manufacturers or end-product companies.
Post-harvest
Stricter oversight will extend to drying, disinfection and decontamination processes. SOPs will need to cover time, temperature and airflow, while microbial reduction methods such as irradiation or ozone treatment must be validated and justified. Fumigant restrictions are expected to tighten, requiring alternatives backed by risk assessments.
Traceability standards will also increase, with requirements for batch-level records covering seed source, cultivation area, propagation batch and harvest date. For indoor growers, this means extensive record-keeping on training, equipment, environmental conditions and staff activities.
Industry implications
Although the final guideline has not yet been published, Lahnakoski warns that regulators and new customers are unlikely to accept systems that are merely ‘in progress.’
Fully validated procedures and controls will be expected from day one, making early preparation critical. If adopted as currently proposed, the changes would significantly raise the compliance bar for medical cannabis producers across Europe and beyond, particularly those seeking to access the EU market.
Companies may need to reassess suppliers, renegotiate contracts, and invest in infrastructure upgrades to ensure audit readiness.
The post No EU Monograph for Cannabis Flowers Over ‘Lack of Evidence’ as New GACP Rules Loom appeared first on Business of Cannabis.
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