EU Medical Cannabis Faces Its Most Consequential Regulatory Overhaul

Cultivation is perhaps the most complex, highly regulated, and expensive part of the cannabis supply chain. 

This is especially true in markets where the end product is classed as a medicine, requiring cultivators to adhere to strict pharmaceutical standards, testing, and record keeping practices. 

As with so many parts of the industry, existing regulations never designed with cannabis in mind now dictate the parameters businesses must operate within. 

Frameworks like GMP and GACP, were once considered to be an unnecessary bureaucratic hurdle among many in the industry. Now, as the industry has progressively adopted a more pharmaceutically focused mindset, they have become a necessary starting point. 

These requirements are now changing. Europe’s medical cannabis operators now face the most consequential simultaneous overhaul of their regulatory environment since the market took shape. 

Five distinct reform processes, covering cultivation standards, post-authorisation manufacturing compliance, medicines licensing law, variety development and cross-border trade, are either already in force or close to being adopted. 

Cultivation: New GACP Standards Already in Force

The simplest way to understand GACP (Good Agricultural and Collection Practice) is as the regulatory framework governing the cultivation of plant-based starting materials for medicines, including everything from valerian and echinacea to St John’s Wort, and a long list of others. Cannabis, when grown for the medical market, falls into this framework too. 

The European Medicines Agency (EMA) last updated GACP guidance in 2006. Last July, two decades later, a new revision was published significantly updating that framework for cultivators of medicinal crops. 

For indoor cultivators, Annex 1 of the revised guidelines now states that ‘critical quality attributes and critical process parameters should be identified,’ 

“Cultivation process should be standardised in order to ensure reproducible results. Qualification of critical equipment and ancillary systems should be completed.”

The language, says Evan Smith, Founder and CEO of Cicada Limited and a regulatory specialist, is ‘GMP in everything but name.’

The new rules require indoor cultivators to formally define what a quality end product looks like before they can set meaningful process controls, and they cannot simply point to an existing published standard to do it. 

The revised GACP guidance now expressly addresses cannabis, but whole-flower cannabis still presents a more difficult question than many traditional herbal materials. Where the flower itself is supplied as the medicine, quality is created through genetics, mother plants, cultivation, harvest, drying and curing. Equipment, lighting, climate systems and drying machinery therefore need to be qualified or validated against documented specifications, in much the same way as critical systems in pharmaceutical manufacturing. 

“For indoor medicinal cannabis, a purely agricultural approach is not enough,” says Smith. “GACP is now using the language of pharmaceutical process control: critical quality attributes, critical process parameters, standardisation, qualification and reproducibility. That is GMP logic, even if the label still says GACP.” 

However, there is no certifying body for GACP compliance. The revised text says that GACP ‘should’ be verified through regular audits, and that audit responsibility falls to EU distributors checking their non-EU suppliers. 

In practice, the parties with the strongest financial incentive to keep costs down are conducting their own compliance checks. 

“We as the people who are importing the product will need to get on planes, will need to go down there, audit these organisations and make sure that they are adhering to those rules,” says Americo Folcarelli, co-founder of Extraction Solutions, an EU-GMP certified contract manufacturing organisation based near Alicante. “Because if you don’t, you end up in the same quagmire.”

Smith added: “Where formal regulatory assurance is incomplete, more responsibility shifts onto commercial due diligence. The question is whether buyers have enough visibility, expertise and commercial incentive to distinguish genuine quality systems from superficial claims.” 

The revision also sharpens a more fundamental question about where pharmaceutical regulation should begin for whole-flower cannabis. Smith’s position, set out in a report submitted to the MHRA and the EMA, is that the industry has often tried to fit whole-flower cannabis into frameworks developed for more conventional herbal materials, rather than building a control strategy around the specific risks of the product and process. 

Annex 7 of the EU GMP guide remains relevant to herbal medicinal products, particularly where plant material is processed into extracts, tinctures, oils or other preparations. Smith argues, however, that whole-flower cannabis exposes a gap in that framework because the harvested flower itself is the patient-facing medicine. In that context, parts of Annex 2 are useful by analogy because they deal with products whose quality is generated by living systems and cannot simply be tested or remediated into compliance at the end. 

The point is not that cannabis is identical to a biological medicinal product. It is that the regulatory logic is similar in important respects. The product is generated by a living system, and many of its critical quality attributes are determined upstream: genetics, mother plants, propagation, cultivation, harvest, drying and curing. Post-harvest remediation may have a role, but it should not be treated as a substitute for controlling the root causes of contamination, degradation or quality variation. 

Smith says some operators may have made investment decisions based on earlier or looser interpretations of where pharmaceutical control begins. “If regulators, auditors or serious buyers now apply a more product-specific reading, some historic assumptions may need to be revisited.”  

In Germany, a formal information sheet issued by the Hessian State Office for Health and Care (HLfGP) on June 08 states that the office 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 document demands gap analyses and implementation plans from all affected operators.

MEDCAN24 will report on its full implications in the coming days. 

For any cultivator supplying the EU market, the revised GACP means materially higher documentation and quality system requirements than applied twelve months ago.

Separately, the EMA’s Committee on Herbal Medicinal Products published a draft public statement in 2025 concluding that an EU herbal monograph for cannabis flowers cannot currently be established, a decision with long-term implications for product standardisation across member states.

READ MORE…

Manufacturing: A Tighter Framework for Post-Authorisation Changes

Once a medicine receives its marketing authorisation, the regulatory licence required to sell it, any subsequent change to how it is made, sourced, or specified must be formally classified and approved by regulators. 

Since 15 January 2026, the rules governing that process have been tightened under Commission Delegated Regulation (EU) 2024/1701.

This introduced new and revised variation categories, tightened documentation requirements for chemistry, manufacturing and controls submissions, and revised stability data requirements. 

The number of cannabis-derived products with EU marketing authorisations remains small, with Sativex and Epidyolex remaining the principal examples. For operators pursuing marketing authorisation it is an immediate compliance matter, and sets out the environment they will enter.

Authorisation: The pharma package

The EU Pharmaceutical Package is the most sweeping of the five reforms, the most significant overhaul of European medicines legislation in over 20 years. Political agreement was reached in December 2025, replacing the framework established by Directive 2001/83/EC and Regulation 726/2004. 

The Parliament’s SANT Committee voted in March 2026. Full adoption is expected this summer, with a two-year transition meaning the new framework will not be fully operational until approximately 2028.

Two provisions have drawn particular attention from the cannabis sector. The first is a new ‘breakthrough orphan’ designation, offering 11 years of market exclusivity for products addressing rare conditions with no currently authorised treatment, up from nine years under the standard orphan pathway. 

The second is a regulatory sandbox provision, allowing the Commission to establish bespoke frameworks for medicines that cannot be developed under standard requirements. The cannabis industry has been quick to cite it as a potential pathway. 

This route is designed specifically for therapies where conventional trial methodology is ethically or scientifically impossible, advanced personalised therapies, for instance, where running a placebo trial is not feasible. Proponents argue that severely epileptic children represent a population where withholding treatment for a placebo arm raises genuine ethical questions. 

Smith, however, believes that most of the indications cannabis is regularly prescribed for will not fit this criteria. “Cannabis might be a pain in the ass, but it doesn’t mean you can’t do clinical trials on it, the biggest problem is there’s no financial incentive,” he said. 

The package also introduces a 180-day deadline for the EMA’s CHMP to issue opinions on valid marketing authorisation applications, a reform that should accelerate timelines for medicines that have historically faced extended review.

Vertanical, the German pharmaceutical company developing VER-0, expects the product to be available in Germany in 2026, with mutual recognition procedures planned for other EU markets. It represents the clearest illustration of what the reformed authorisation landscape means in practice.

Variety Development: Gene Editing Approaches a Vote

The fourth reform concerns the longer-term question of cannabis variety development. The EU’s New Genomic Techniques regulation ends the effective ban on gene-edited crops that followed a 2018 Court of Justice ruling. Provisional agreement was reached in December 2025, and the ENVI Committee adopted the text in January 2026. A full plenary vote is now expected imminently.

The regulation splits genetically modified plants into two categories. NGT-1 covers plants with up to 20 genetic modifications that could theoretically have occurred through natural processes. These are exempt from GMO legislation and do not require consumer-facing labelling. NGT-2 applies to more complex edits and retains full GMO-level requirements.

For cannabis growers, a variety engineered to eliminate THC production through a targeted gene knockout would likely qualify for NGT-1, opening a lighter-touch pathway for pharmaceutical-grade, genetically consistent cultivars. 

England has moved ahead of the EU. The Precision Breeding Regulations 2025 came into force in November, establishing a comparable but not identical pathway for gene-edited crops. Home Office licensing under the Misuse of Drugs Act 1971 applies to all cannabis cultivation, including research using gene-edited varieties. No guidance has been published on how the two frameworks interact specifically for cannabis. 

Trade: The SPS Agreement and What It Leaves Open

The fifth reform is a trade agreement impacting operators who span both the UK and the EU. In May 2025, the UK and EU agreed in principle to establish a Common Sanitary and Phytosanitary Area, targeting implementation from mid-2027. 

Export Health Certificates, costing up to £200 per consignment, would no longer be required for plant products moving between the UK and EU. Routine border checks on certain categories would be removed.

While this would potentially be good news for CBD and hemp traders who routinely have their shipments seized by the authorities, it also creates complexities. 

The SPS framework covers plant products, and  cannabis is simultaneously a plant product and a controlled drug. No clarification has emerged on how that dual status is handled within the agreement. 

On gene editing, the UK has declined to dynamically align with the EU, a divergence that remains an unresolved sticking point in negotiations, with direct implications for any operator developing gene-edited cannabis varieties for both markets.

As we’ve previously reported, the SPS agreement could also all but wipe away the progress the UK has made towards becoming the first country to regulate CBD as a novel food. Under the agreement, the UK would automatically adopt EU rules in covered areas, a mechanism that threatens to overtake the UK’s five-year CBD novel food approval process before a single domestic authorisation is finalised. 

The Intersections Nobody Has Mapped

While none of these regulatory updates were made either in conjunction with each other, or with cannabis in mind, together they represent one of the largest policy shifts in the sector’s history. 

Given they’re all newly enforced or imminent, how each of these new requirements will interact with another is not yet fully understood, and each raises as many questions for cannabis operators as it does answer questions. 

That said, the cannabis industry is no stranger to regulatory complexity. As the playing field continues to shift beneath the industry, the players who have built both high quality regulatory oversight and the ability to adapt quickly into their foundations will have a significant leg up on their competitors,