Bedrocan welcomes new European monograph for cannabis flowers

Europe has now the long-awaited quality standard monograph for cannabis flowers. The European Pharmacopoeia Commission officially published the monograph at the beginning of the year, and it will come into force as of July 2024. Many experts and members of the cannabis industry were invited to collaborate on the content. Now that the document has been officially published, Bedrocan welcomes the launch of official quality requirements for medicinal cannabis and hopes it will push more standardised cannabis legislations in Europe and countries that follow European standards.

Quality requirements

The new monograph Cannabis Flower (Cannabis Flower, monograph 3028) describes in detail the required quality of cannabis flowers for patient use. Among other things, the monograph establishes a maximum accepted deviation of 10% from the declared THC and CBD content on the product label. It also mentions the maximum acceptable levels of heavy metals and how to carry out tests that assure the quality of cannabis flowers in milled or ground forms. In general, the EDQM aimed to apply the highest pharmaceutical quality standards to cannabis. Bedrocan Founder Tjalling Erkelens: “It is of the utmost importance for patients and their healthcare providers to be able to rely on more consistent and standardised cannabis and cannabis derivatives. This new monograph is very helpful in that regard.”

monograph cannabis flowers

More harmonisation

The monograph is an important milestone towards the harmonisation of quality requirements for medicinal cannabis. Currently, cannabis legislations vary a lot between countries. Many countries in and outside the European Union (EU) use the European guidelines as a standpoint for their local legislation regarding the quality of medicines. The standards of the European Pharmacopoeia are legally binding in thirty-nine states, not only in the EU. Many other countries, including the US and Canada, also use it as a reference. The harmonisation of standards on such a scale is beneficial to any conventional pharmaceutical product, but it was urgent for medicinal cannabis. Now, Bedrocan hopes there will be more convergence in quality requirements for medicinal cannabis products worldwide. Tjalling: “I hope and expect the global industry and legislators in various countries to embrace this important step forward now set by the EDQM.”

European Pharmacopoeia

The European Pharmacopoeia is the main source document for quality control of medicines. It is elaborated by the European Directorate for the Quality of Medicines & Healthcare (EDQM), which aims to ensure the harmonisation of quality standards for medicines in the European continent and beyond. Since its first version in 1969, the pharmacopoeia has been constantly updated. The document consists of a number of monographs, each describing in detail the expected quality of different categories of medicines, pharmaceutical preparations and their ingredients. The guidelines in the European Pharmacopoeia become mandatory on the same date in all countries part of the convention. This means that all pharmaceutical companies active in these countries must meet the quality requirements described in the monographs in order to market their products.


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