New markets can only raise, when regulation changes. Thats what happened this month in a court in Düsseldorf, Germany. Its all about the question: How many work steps must be added in the pharmacy so that dronabinol can still be dispensed as a magistral preparation? According to the Düsseldorf Administrative Court (VG), testing, filling, bottling and labeling are not manufacturing steps. The judges classified Caelo’s kit as a finished medicinal product and therefore prohibited its marketing.
“The transfer of the simplest manufacturing activities such as testing, decanting and labeling the product to the pharmacy does not lead to the intervention of the prescription privilege,” is the main guiding principle of the ruling from October 25. Instead, Dronabinol, as a finished medicinal product, is subject to authorization in accordance with the German Medicinal Products Act (AMG). This applies in particular because, after being manufactured in an industrial process, it is “placed on the market in the pharmaceutical form and composition intended for distribution to the consumer and its substance is no longer altered by the pharmacy”.
It will get banned? For sure!
Two years ago, the Düsseldorf district government announced that it would prohibit the further marketing of the Dronabinol solution for a fee. Caelo had argued that the Dronabinol solution supplied to pharmacies was not suitable for dispensing to the end consumer, but was intended for the preparation of an individual prescription by the pharmacy. Before it could be dispensed to patients, it had to be transferred into a glass container with a child-resistant closure, labeled and accompanied by a dosing aid, in each case in accordance with DAC/NRF 22.8.
However, the competent authority was not convinced and prohibited further distribution under threat of a penalty payment of 100 euros per pack. Caelo defended itself in court and was at least able to avert immediate enforcement in summary proceedings.
Ready to use from the manufacturer
However, the manufacturer has now lost the main proceedings. The Administrative Court found that the essential manufacturing step for readiness for distribution already took place at the supplier and not in the pharmacy: “In any case, readiness for distribution is achieved when the medicinal product is placed on the market in the pharmaceutical form and composition intended for distribution to the consumer and is no longer altered in its substance by the pharmacy.” Subsequent steps such as filling and repackaging do not change this. For the same reason, it is not a magistral medicinal product.
Section 4 of the German Medicinal Products Act (AMG) is relevant: “Finished medicinal products are medicinal products which are manufactured in advance and placed on the market in packaging intended for supply to the consumer or other medicinal products intended for supply to consumers, the preparation of which otherwise involves an industrial process or which, except in pharmacies, are manufactured commercially.”
According to the VG, it is already clear from the wording that a finished medicinal product can also be one that has been “prepared” but for which not all further manufacturing steps such as “filling” or “packaging” have yet been carried out. This is because if the first statement expressly refers to placing on the market “in packaging intended for supply to consumers”, the second statement can only mean “that packaging intended for supply to consumers is in any case not required”.
Consumer protection without loopholes
The decisive factor, however, is the meaning and purpose of the authorization requirement, namely the protection of drug safety to ensure consumer health. “The legislator ensures this depending on the type of manufacture.”
Finished medicinal products would be distinguished from magistral preparations that are not manufactured industrially and in advance, which are produced in individual cases on special request or prescription. “The legislator sees a particular risk with medicinal products that are manufactured for any number of cases without regard to a specific case of illness.”
According to the court, any other interpretation would lead to “gaps in protection”. “If the transfer of the simplest manufacturing activities to the pharmacy were already covered by the prescription privilege, the protective mechanism provided for industrial manufacturing would become obsolete. It would be possible to re-declare unauthorized medicinal products or even those whose authorization has been revoked due to harmful effects as an authorization-free pharmacy prescription simply by refilling or repackaging. This would result in a considerable risk to drug safety and patient health.”
Pharmacy has no influence
The labeling by the manufacturer is irrelevant, as it is not only the manufacturer’s written subjective intention that is important. From an objective point of view, a finished medicinal product is to be assumed, as the Dronabinol solution is already produced in the dosage form and composition in which it is later dispensed to an indefinite number of consumers: “The substance of the solution is no longer changed by the pharmacy. At most, the pharmacy can decide on the basis of the use of the test kit that it will not dispense the product to consumers due to a lack of efficacy.”
Theoretically, the pharmacy could also dilute the product, but there are no known cases of this being used in practice. “Accordingly, the pharmacy has no influence whatsoever on the composition, quality and mode of action of the product. In this respect, the entire drug-specific risk of manufacture lies with the plaintiff, so that the manufacturing process must be secured by a drug approval.”
Refilling is not mandatory
It is irrelevant that the pharmacy checks the Dronabinol solution: According to Section 6 of the German Pharmacy Operating Regulations (ApBetrO), this is not a step in the manufacturing process: “Medicinal products that are manufactured in the pharmacy [are] to be manufactured and tested in accordance with recognized pharmaceutical rules.” In addition, finished medicinal products are also randomly tested. Conversely, Caelo could not completely outsource the risk under pharmaceutical law to the pharmacy due to the “over-obligatory testing requirement”.
Transferring the solution into a container with a child-resistant cap and dosing aid is also not a special feature, as the pharmacy could also dispense the solution without doing so: “It is not absolutely necessary to attach a child-resistant cap in the pharmacy before dispensing the dronabinol solution to the end consumer, although it may make sense from a technical point of view.” A legally binding requirement of the Federal Institute for Drugs and Medical Devices (BfArM) only exists for benzomorphane derivatives, natural opium alkaloids and opioids. This does not include dronabinol.
There is also no need to refill the solution because of any quantities permitted under narcotics law. A maximum prescription quantity is no longer prescribed for Dronabinol under narcotics law. “In this respect, any container used by the plaintiff (10 to 200 ml) could also be considered for dispensing to consumers.”
“Insofar as DAC/NRF 22.8 requires the addition of a child-resistant closure, this requirement has no equivalent legally binding force,” the ruling continues. An assessment by the German Pharmacists’ Association (DAV) is also of no significance, as it cannot make legally binding decisions.
No inference from AMPreisV
Nothing can be inferred from the German Drug Price Ordinance (AMPreisV) either, as although it is based on the definitions of the AMG, it cannot be decisive for its interpretation. “A scope of application remains for cases in which active ingredients themselves can exceptionally be used as medicinal products without any treatment or processing (dual use).”
The fact that the Berlin State Office for Health and Social Affairs (LaGeSo) classified an equivalent Dronabinol preparation as a prescription is irrelevant, as the district government decides on its own responsibility. And the fact that the authority itself had certified the quality as a prescription drug in the case of opium tincture also played no role for dronabinol: “It is already doubtful to what extent this statement could have become legally binding. In any case, it refers to a different product.”
Medical Cannabis Extracts in Germany: Trends, Pricing, and Market Insights
The German medical cannabis market continues to evolve, with extracts emerging as a vital category alongside flower products. Offering a range of benefits for patients and medical professionals, extracts present distinct pricing structures, product characteristics, and market dynamics that set them apart.
Pricing Trends in Medical Cannabis Extracts
Medical cannabis extracts exhibit a unique pricing framework influenced by their composition and intended use. An analysis of 88 extract products reveals the following trends:
- Mean price: €11.25 per millilitre
- Standard deviation: €7.62
- Price per active milligram: €0.31 on average, with a standard deviation of €0.12
These figures highlight the significant variation in pricing, which can be attributed to differences in production methods, active ingredient concentrations, and origin countries.
Product Composition and Dominance
The majority of extracts remain THC-dominant, but the category also includes a higher proportion of CBD-dominant and balanced products compared to cannabis flowers. This diversity allows medical professionals to tailor treatments to specific therapeutic needs, making extracts a versatile option for various patient groups. Also, there are extracts for combined oral and inhalation use.
In the future, “nature-identical” extracts that preserve the natural terpene profile are likely to play a significant role. Similarly, extracts designed for vaporization are expected to gain importance.
Global Contributions: Countries of Origin
The production of medical cannabis extracts demonstrates a balanced global contribution, with approximately 50% of products imported from countries such as:
- Australia
- Israel
- Germany
- Portugal
- Canada
This international footprint reflects the growing integration of Germany into the global cannabis supply chain, with domestic and international producers catering to the increasing demand for extracts.
Market Leaders in Extract Distribution
Key players dominate the German medical cannabis extracts market, led by Tilray and STADA, which holds the majority of the market share, with Cantourage also being significant
contributors..
Other significant contributors include:
-
- Demecan
- Canymed
- BECANEX
- Tilray
- AVEXTRA
- AURORA
These companies play a critical role in ensuring the availability and consistency of extract products for patients and healthcare providers across the country.
Conclusion
Medical cannabis extracts are carving out a significant niche in Germany’s growing cannabis market. With competitive pricing, international sourcing, and strong distribution networks, extracts are poised to become a cornerstone of medical cannabis therapy. As global and domestic producers continue to innovate, this category will likely see further expansion, offering even more options to patients seeking tailored medical solutions.
Why This Matters for Cannabis Extract Suppliers
This ruling creates a compelling opportunity for suppliers of cannabis extracts to expand their market presence. Here’s why:
- Growing Demand for Ready-to-Use Products: With pharmacies now facing stricter rules, many will opt for pre-approved, ready-to-use products instead of managing the costly and time-consuming steps required for compliance.
- Regulatory Advantage: Licensed manufacturers who can supply high-quality, finished medicinal products are positioned to dominate the market, as pharmacies shift away from compounding to purchasing pre-packaged solutions.
- Market Expansion: The demand for compliant Dronabinol and other cannabis-based extracts is set to rise. This offers an excellent entry point for suppliers ready to navigate Germany’s strict regulatory framework.
How Extract Suppliers Can Seize This Opportunity
For extract suppliers with existing portfolios or those entering the market, now is the time to act. Key strategies include:
- Collaborations with Pharmacies: Partner with pharmacies to provide turnkey solutions that simplify compliance.
- Innovation: Develop advanced formulations, such as capsules, tablets, oromucosal formulations and formulations for vaping and/or inhalation., that cater to patient needs and pharmacy preferences.
- Quality Assurance: Build trust by maintaining rigorous testing and quality standards as definded in GMP and the Euoropean Pharmacopeia, demonstrating a commitment to patient safety.
A New Era for Cannabis Businesses
This ruling marks a pivotal moment for the cannabis industry. For suppliers of cannabis extracts, the path forward is clear: invest in quality, innovate, and align with Germany’s evolving regulatory landscape. With the right approach, this is a chance to lead the market and shape the future of medicinal cannabis.
As always, Cannabis-Startups.com is here to support your growth. Stay tuned for more insights and opportunities!
This Report is proudly sponsored by ELIXIE.
