The Importance of the EU-Monograph on Cannabis Flowers for Patients across Europe

From the 1st of July, a new framework, the Cannabis Flower Monograph of the European Pharmacopoeia (Ph. Eur.) is set to be implemented in 39 countries, establishing a gold standard for the quality, safety, and efficacy of medical cannabis products. Join us as we unpack these developments, understand their broader impact, and consider what this means for the future of medical cannabis therapy across the EU.

Enhanced Quality and Safety

EU monographs are crucial documents that establish quality standards for medicinal products. Essentially, a monograph is a detailed written study that provides specifications for the identity, purity, and quality of a medicinal substance. It includes tests, procedures, and acceptance criteria, which are legally enforceable in regulatory settings.

Germany, along with other European countries such as the Netherlands, has played a pioneering role in establishing strict standards for medical cannabis, significantly influencing the framework for the EU. The development of the Cannabis Flower Monograph for the German Pharmacopoeia (Deutsches Arzneibuch, DAB) began in 2015, shortly after the announcement of new legal regulations for the medical use of cannabis flowers and extracts. The first version of such a monograph was published in May 2016 in the German Drug Codex (Deutscher Arzneimittel-Codex, DAC) and was later revised multiple times.1 These strict standards, together with those of other leading European monographs such as the Dutch, inspired the development of the new EU Monograph by the European Pharmacopoeia (Ph. Eur.), which harmonizes quality requirements within the EU.

In October 2022, the European Pharmacopoeia (Ph. Eur.) published the initial draft of its new cannabis flower monograph, seeking feedback from the public.2 After a period of public consultation, the draft reflects a collaborative effort to incorporate stakeholder feedback into the regulations. This inclusive approach ensures that the monograph addresses the concerns of manufacturers, healthcare providers, and patients alike, promoting broader acceptance and adherence.

What does the new cannabis flower monograph say?

Key aspects of the monograph include stringent controls on the chemical composition of the cannabis flower. For instance, the contents of total tetrahydrocannabinol (THC) and total cannabidiol (CBD) in the product must not deviate from the label by more than ±10 percent. This ensures that patients receive medications consistent with what is prescribed, enhancing both safety and efficacy.

Additionally, the monograph specifies that foreign matter must constitute no more than 2% of the preparation, and defines that prescribed cannabis flower must not contain any seeds or leaves longer than 1.0 cm. These measures prevent contamination and ensure product purity but may present challenges for some manufacturers.

Noteworthy revisions within the EU monograph include the increase in allowable drying loss from 10% to 12%. Additionally, arsenic has been newly classified as a heavy metal, leading to significantly stricter permissible limits for heavy metal contamination—a positive development enhancing patient safety.

Legal and Regulatory Impact

The Ph. Eur. Cannabis flower monograph, which will replace existing national monographs in countries like Germany, Denmark, the Netherlands, and Switzerland, is legally binding. This means that from July 1, 2024, all medical cannabis products in the EU must comply with these standards. This harmonization eliminates discrepancies in quality standards across borders, facilitating analyses in laboratories and pharmacies as well as smoothening regulatory processes and market operations.

This updated EU monograph represents a crucial step toward uniform quality standards across the EU, ensuring that all medical cannabis products adhere to stringent guidelines prioritizing patient safety and treatment effectiveness. Despite the many challenges cannabis patients face, such as access difficulties, and the stigma surrounding the therapy, we are heartened by these small but significant improvements. These changes promise to enhance the therapeutic experience for patients across Europe, ensuring they receive the safest and most effective treatments possible.

Anything else?

Do you have specific questions or suggestions for the Cannabis Briefing? Then send us an email to briefing@cansativa.de. If you are interested in revolutionising the cannabis industry with us, then stay tuned and follow our briefings!

We wish you a good read!

With legalising greetings,