EU Medical Cannabis Regulations Undergo the Most Significant Changes

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

It is particularly true for markets in which the final product is classified as a drug, where cultivators are required to follow strict standards of testing and documentation, adhere to pharmaceutical standards. 

Existing regulations, which were never intended for cannabis businesses, now set the boundaries within which they must operate. 

Previously, many industry professionals considered frameworks such as GMP and GACP to be unnecessary bureaucratic obstacles. As the pharmaceutical industry continues to evolve, these frameworks have now become necessary. 

The requirements have changed. The regulatory landscape for medical cannabis in Europe has undergone the biggest change since it began. 

The five distinct reform processes – covering the cultivation standards, manufacturing regulations, licensing laws for medicines, varieties development, and international trade – are already either in place or about to be adopted. 

GACP Cultivation Standards: Already In Force

GACP, or Good Agricultural and Collection Practice, can be understood as the regulatory structure that regulates the cultivation of medicinal plants, such as valerian, echinacea and St John’s Wort. Cannabis grown to be used for medical purposes also falls under this umbrella. 

Last updated in 2006 by the European Medicines Agency, GACP was a guideline that is provided to growers of medicinal crops. Two decades after the last update, in July of this year, an important revision for growers of medicinal plants was released. 

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

The cultivation process must be standardised to guarantee reproducible results. It is important to complete the qualification of all critical systems and equipment.

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

Indoor cultivators must now define formally what quality looks like in order to set up meaningful controls. They cannot just point at an existing standard. 

GACP’s revised guidance explicitly addresses cannabis. However, the whole-flower material still raises more questions than most traditional herbs. Quality is created by the genetics of mother plants and cultivation. It is also determined by harvesting the flowers, drying them, and curing. The equipment, lighting systems, climate control systems, and drying machines must be validated or qualified against specified specifications. This is similar to the process of manufacturing pharmaceuticals. 

Smith says that a pure agricultural approach to indoor medical cannabis is insufficient. GACP uses the terminology of pharmaceutical processes control, including critical attributes and critical parameters. Standardisation, qualification, and reproducibility are also included. It is GMP logic even if it still reads GACP on the label. 

Yet, GACP does not have a certifying agency. The revised text says that GACP ‘should’ Regular audits will be carried out by EU distributors to ensure that their non EU suppliers are compliant. 

In reality, those with the greatest financial incentives to reduce costs are the ones who conduct their own checks of compliance. 

Americo Focarelli, cofounder of Extraction Solutions near Alicante, a contract manufacturing company certified EU-GMP, says: “We, as people who import the product, will have to fly down, audit these organizations and ensure that they adhere to those rules.” Because if you do not, you will end up in the exact same mess.

Smith said: “Where formal regulatory approval is not complete, commercial due diligence becomes more important.” Buyers need to have the expertise, visibility and financial incentive necessary to tell a genuine quality system apart from a superficial one. 

This revision has also raised a fundamental question as to where the pharmaceutical regulations should start for whole-flower marijuana. Smith, in a document submitted to the MHRA, argues that whole-flower cannabis has been regulated using frameworks designed for herbal products. 

The EU GMP Guide, Annex 7, remains applicable to herbal medicines, especially where the plant material has been processed into oils, extracts or tinctures. Smith claims, however, the entire-flower cannabis reveals a hole in this framework, because the harvested flowers are the medicine that is used by patients. Parts of Annex 2 can be used as an analogy in this context because it deals with products that are generated by living organisms and therefore cannot just be tested for compliance or remedied at the end. 

Not that marijuana is the same as a biologic medicinal product. The regulatory logic in some important aspects is the same. A living system generates the product, and many critical qualities are established upstream, such as genetics and mother plants. Although post-harvest cleanup may be important, it shouldn’t replace the control of root causes for contamination, degradation, or variation in quality. 

Smith believes that certain operators could have made investments based upon earlier or more loose interpretations as to where the beginning of pharmaceutical control is. If regulators, auditors, or serious buyers apply a product-specific interpretation, it may be necessary to revisit some historical assumptions.  

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.’ 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 which has demonstrably shown that flowers still legitimately regarded as GACP can be transported, stored imported or further processed over long distances without loss in quality.

MEDCAN24 We will be reporting on the full impact of this in the next few days. 

The revised GACP will require significantly more documentation and a higher quality system for any grower supplying EU markets.

In 2025, the EMA Committee on Herbal Medicinal Products released a public draft statement concluding there is no EU herb monograph on cannabis flowers. This decision will have long-term effects on product standardisation in all member states.

READ MORE…

The Manufacturing Industry: Tighter Controls for Changes After Authorisation

Once a drug has received its regulatory license, which is required for it to be sold, all subsequent changes to the way it’s made, specified, or sourced must be classified by and approved of regulators. 

The rules that govern this process are now more stringent since 15 January 2026 under the Commission Delegated Regulation 2024/1701.

It introduced new categories of variation, revised documentation requirements, for submissions related to chemistry, manufacturing, controls, and stability data, and tightened the requirements. 

Sativex Epidyolex remain the main examples of products derived from cannabis that are EU-approved for marketing. Operators pursuing marketing authority must comply immediately and understand the market they are entering.

Authorisation for the Pharma Package

The EU Pharmaceutical Package represents the largest of five reforms and the biggest overhaul in European medicine legislation for over twenty years. A political agreement has been reached for December 2025 to replace the Directive 2001/83/EC & Regulation (726/2004) framework. 

SANT Committee votes in Parliament March 2026 This summer is when the full implementation will be completed. A two-year period of transition means that this new framework won’t become fully operational before approximately 2028.

The cannabis industry is particularly focused on two specific provisions. 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. 

A regulatory sandbox is the second provision. This allows for a bespoke framework to be established by the Commission in order to create medicines that are not able meet standards. Cannabis industry representatives have cited it as an alternative pathway. 

It is intended for treatments where traditional trial methods are either ethically or science-wise impossible. For example, a trial of advanced, personalised therapy isn’t feasible. Some proponents say that withholding therapy for severely epileptic kids raises ethical concerns. 

Smith however believes that cannabis will not be prescribed in most cases. He said that although cannabis is a “pain in the arse”, it does not mean it cannot be used for clinical trials. The biggest issue, he says, is the lack of financial incentives. 

This package introduces a deadline of 180 days for CHMPs at the EMA to give opinions on marketing authorization applications that are valid.

Vertanical – the German pharmaceutical development company – expects VER-0 to be on German shelves by 2026. There are plans for mutual recognition in other EU countries. This is the most clear illustration of the new authorisation framework in action.

Gene Editing: A Vote is Near

Fourth reform is a longer-term issue of the development of cannabis varieties. New Genomic Techniques Regulation in the EU ends the legal ban of gene-edited crop varieties that resulted from a Court of Justice decision of 2018. The ENVI Committee approved this text on January 20, 2026, after reaching a preliminary agreement in December 2025. The full plenary will vote on the text in the near future.

Two categories of plants are classified under the regulation. NGT-1 includes plants that have up to 20 genetic changes, which could theoretically be caused by natural processes. They are not subject to GMO laws and don’t require labelling for consumers. NGT-2 is applicable to complex edits that retain full GMO 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 is ahead of EU. Precision Breeding Regulations 2020 came into force on November 1, establishing a pathway that is similar, but not identical for gene-edited crop. Home Office licensing, under the Misuse of Drugs Act of 1971, applies to cannabis cultivation in general and includes research involving gene-edited strains. There are no published guidelines on the interaction between these two frameworks for cannabis. 

SPS Agreement: What it leaves open and what is left out

Five reforms are a set of trade agreements that affect operators in both the UK as well as the EU. The UK and EU reached an agreement in May 2025 to create a Common Sanitary Phytosanitary Zone, with implementation slated for 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. The routine border check on some categories will be eliminated.

Although this could potentially be a positive for CBD and Hemp traders, who have had their shipments confiscated by the government on a regular basis, it creates complications. 

The SPS framework covers plant products, and  cannabis is simultaneously a plant product and a controlled drug. The agreement has not clarified how this dual status will be handled. 

In the area of gene editing, UK officials have refused to adopt a dynamic alignment with EU. This is a major divergence in the negotiations that has repercussions for operators who wish to develop gene-edited marijuana varieties for the two markets.

The SPS agreement, as we have reported previously, could wipe out the progress that has been made in the UK to become the first country to regulate CBD-rich foods. According to the agreement, UK will automatically adopt EU laws in certain areas. A mechanism which threatens the UK’s five-year CBD novelty food approval before any domestic authorization is completed. 

No One Has Mapped the Intersections

These regulatory changes were not made in tandem or in consideration of cannabis, but they together represent the biggest policy change in the history of the industry. 

Since they all are new, or will be soon, we don’t know how the requirements of each one will interrelate. This raises just as many questions as answers for cannabis businesses. 

The cannabis industry has a long history of regulatory complexity. Players who are able to quickly adapt and maintain high-quality regulatory oversight will be able to gain a competitive advantage as the landscape continues to change.