The Committee on Natural Medicinal Merchandise (HMPC) of the European Medicines Company (EMA) revealed a draft opinion on July 09, open for session between 1 August and 31 October 2025, which concludes that no EU monograph can presently be created for Hashish sativa L., flos.
Following a knowledge request in early 2023 and a complete evaluation, the HMPC mentioned there are presently no authorised medicines within the EU made completely 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 trade analyst Alfredo Pascaual, the info obtainable 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 combined purposes and merchandise based mostly on remoted cannabinoids. The one cannabis-based medicinal product permitted within the EU stays a mixture product authorised in 2011.
“The HMPC is of the opinion that it’s not attainable to determine a European Union natural monograph on Hashish sativa L., flos, at current. In abstract, no conclusions could be drawn because of the 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 crops used within the manufacture of medicines and different merchandise are grown and picked up in accordance with strict high quality and security requirements.
In step with EU directives, GACP covers the whole technique of plant manufacturing and harvesting, from the selection of cultivation space and management of fertilisers and pesticides to environmentally sound practices. Put up-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. Corporations adhering to GACP are recurrently audited to confirm requirements are met, defending each shopper well being and the surroundings.
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 had been first revealed in 2006, and have remained largely unchanged. In 2024, nevertheless, a session on vital revisions was launched. The HMPC’s work plan signifies that the up to date steering 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 affect on hashish companies, notably exporters to the EU. In her view, the revisions sign a convergence between GACP and Good Manufacturing Apply (GMP), particularly for indoor and greenhouse cultivation.
Some hashish firms have been identified to make use of packaging processes to reclassify GACP-compliant merchandise as GMP-compliant. Lahnakoski argues that this, partially, has pushed regulators to make clear boundaries.
For the primary time, the proposed steering explicitly references ‘EudraLex Quantity 4 Annex 7’ and units out when post-harvest actions reminiscent of drying and reducing fall below GMP Half I or II. This is able to create a clearer line between GACP and GMP, and probably go away the trade with vital work to implement the modifications inside six months of publication.
Getting ready for compliance
To arrange, Lahnakoski recommends firms conduct early hole analyses to determine cultivation areas requiring validation. Environmental parameters reminiscent of gentle, humidity, temperature and airflow ought to 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 normal working procedures (SOPs) for drying, microbial decontamination, cleansing, and pest management requiring validation and detailed data. Producers might also face new obligations below written high quality agreements, subjecting them to common inspections by producers or end-product firms.
Put up-harvest
Stricter oversight will lengthen to drying, disinfection and decontamination processes. SOPs might want to cowl time, temperature and airflow, whereas microbial discount strategies reminiscent of irradiation or ozone therapy should be validated and justified. Fumigant restrictions are anticipated to tighten, requiring alternate options backed by threat assessments.
Traceability requirements may even improve, with necessities for batch-level data masking seed supply, cultivation space, propagation batch and harvest date. For indoor growers, this implies intensive record-keeping on coaching, tools, environmental circumstances and employees actions.
Trade implications
Though the ultimate guideline has not but been revealed, Lahnakoski warns that regulators and new clients are unlikely to just accept methods which are merely ‘in progress.’
Totally validated procedures and controls will probably be anticipated from day one, making early preparation vital. If adopted as presently proposed, the modifications would considerably increase the compliance bar for medical hashish producers throughout Europe and past, notably these searching for to entry the EU market.
Corporations could must reassess suppliers, renegotiate contracts, and put money into infrastructure upgrades to make sure audit readiness.
