The Committee on Natural Medicinal Merchandise (HMPC) of the European Medicines Company (EMA) printed a draft opinion on July 09, open for session between 1 August and 31 October 2025, which concludes that no EU monograph can at the moment be created for Hashish sativa L., flos.
Following a knowledge request in early 2023 and a complete evaluation, the HMPC mentioned there are at the moment no authorised medicines within the EU made solely from hashish flowers. Though some formulations exist in particular person member states, none have been formally evaluated or authorised by nationwide regulators for particular indications, strengths or dosages.
As highlighted in a LinkedIn publish by business analyst Alfredo Pascaual, the info out there additionally doesn’t meet the necessities for ‘established use’ or ‘conventional use,’ missing consistency, outlined high quality requirements and enough proof of security, efficacy and continued medical software.
Mandate restrictions additionally play a job, because the HMPC’s remit is proscribed to natural medicinal merchandise, with the one exceptions being stand-alone or blended functions and merchandise based mostly on remoted cannabinoids. The one cannabis-based medicinal product authorised within the EU stays a mixture product authorised in 2011.
“The HMPC is of the opinion that it isn’t doable to determine a European Union natural monograph on Hashish sativa L., flos, at current. In abstract, no conclusions will be drawn as a result of absence of medicinal merchandise with single natural preparations from Hashish sativa L., flos on the EU market,” the doc reads.
Good Agricultural and Assortment Practices (GACP)
The GACP system ensures that vegetation used within the manufacture of medicines and different merchandise are grown and picked up in accordance with strict high quality and security requirements.
According to EU directives, GACP covers all the strategy of plant manufacturing and harvesting, from the selection of cultivation space and management of fertilisers and pesticides to environmentally sound practices. Submit-harvest dealing with and storage are additionally regulated to safeguard purity and effectiveness.
Compliance requires full documentation from seed choice to supply, making certain transparency and traceability. Firms adhering to GACP are commonly audited to confirm requirements are met, defending each client well being and the setting.
READ MORE: EU Proposal to Recognise Hemp Flower as a Crop in Landmark Shift for Trade
Adjustments anticipated in 2025
The EU Tips on GACP for natural uncooked supplies have been first printed in 2006, and have remained largely unchanged. In 2024, nonetheless, a session on important revisions was launched. The HMPC’s work plan signifies that the up to date steerage is scheduled for publication in 2025, suggesting an up to date GACP framework is imminent.
Trade analyst Karina Lahnakoski, who has greater than 25 years’ expertise in regulated industries, notes that the proposed modifications are prone to have a considerable impression on hashish companies, notably exporters to the EU. In her view, the revisions sign a convergence between GACP and Good Manufacturing Follow (GMP), particularly for indoor and greenhouse cultivation.
Some hashish corporations have been identified to make use of packaging processes to reclassify GACP-compliant merchandise as GMP-compliant. Lahnakoski argues that this, partly, has pushed regulators to make clear boundaries.
For the primary time, the proposed steerage explicitly references ‘EudraLex Quantity 4 Annex 7’ and units out when post-harvest actions comparable to drying and chopping fall beneath GMP Half I or II. This might create a clearer line between GACP and GMP, and probably go away the business with important work to implement the modifications inside six months of publication.
Making ready for compliance
To arrange, Lahnakoski recommends corporations conduct early hole analyses to establish cultivation areas requiring validation. Environmental parameters comparable to gentle, humidity, temperature and airflow must be tightly managed and logged with calibrated monitoring methods, whereas irrigation water might want to meet not solely native but additionally destination-country requirements.
Documentation will change into more and more central, with commonplace working procedures (SOPs) for drying, microbial decontamination, cleansing, and pest management requiring validation and detailed information. Producers may additionally face new obligations beneath written high quality agreements, subjecting them to common inspections by producers or end-product corporations.
Submit-harvest
Stricter oversight will prolong to drying, disinfection and decontamination processes. SOPs might want to cowl time, temperature and airflow, whereas microbial discount strategies comparable to irradiation or ozone therapy have to be validated and justified. Fumigant restrictions are anticipated to tighten, requiring alternate options backed by threat assessments.
Traceability requirements may also enhance, with necessities for batch-level information masking seed supply, cultivation space, propagation batch and harvest date. For indoor growers, this implies in depth record-keeping on coaching, tools, environmental situations and workers actions.
Trade implications
Though the ultimate guideline has not but been printed, Lahnakoski warns that regulators and new clients are unlikely to just accept methods which might be merely ‘in progress.’
Absolutely validated procedures and controls shall be anticipated from day one, making early preparation essential. If adopted as at the moment proposed, the modifications would considerably elevate the compliance bar for medical hashish producers throughout Europe and past, notably these searching for to entry the EU market.
Firms might must reassess suppliers, renegotiate contracts, and put money into infrastructure upgrades to make sure audit readiness.
