5/6 June 2024
Due to the increased public interest in the therapeutic use of medical cannabis products, EMA´s Committee on Herbal Medicinal Products (HMPC) is often approached by the industry on regulatory questions with regard to market access and regulatory requirements / standards for herbal medicinal products (HMPs). Thus, the European Commission (EC) previously requested a compilation of terms and definitions ("Cannabis Glossary") but also suggested to check the possibility for an EU herbal monograph.
The glossary summarizes existing scientific and legislative terminology taking into account EU legislation on HMPs, EU pharmaceutical quality guidelines and European Pharmacopoeia (Ph. Eur.) standards. In order to establish a broad overview, the HMPC included not only terms related to herbal substances (e.g. plant parts) and herbal preparations (e.g. extracts), but also considered a non-exhaustive list of constituents (e.g. cannabinoids, terpenes, phenolic compounds).
According to the Agency, the compilation aims to compile existing terms and definitions that are relevant in the description and assessment of medicinal products containing Cannabis-derived active substances. In addition, some terms often used outside the pharmaceutical area (e.g., CBD oil", "Cannabis oil") are briefly commented when considered important to minimize the risk of confusion.
According to the document, "Cannabidiol (CBD) oil" is not an accurate expression since it could refer to several types of preparations. CBD oil is commonly used to refer to the following three different types of preparations:
The first preparation is an isolated active substance dissolved in a vegetable fatty oil and does not correspond to the definitions of a "herbal (drug) preparation" or any type of extract described in Ph. Eur. The correct term would be "CBD (dissolved) in <specified fatty oil>". The two other preparations correspond to the Ph. Eur. "herbal (drug) preparation" definitions (e.g. standardized or quantified extracts). According to the EMA, the term "CBD oil" does not correspond to an accurate description of the active substance. Thus, it could be misleading and should not be used.
"Cannabis oil" is also not an accurate expression since it could refer to several types of preparations. The term is commonly applied to both the herbal drug preparation (e.g. extract) and the finished product (e.g. Cannabis extract in an oily solvent to be used as oral drops), like, for example:
The second preparation corresponds to the definitions of liquid extraction preparations - possible as standardized or quantified extract according to Ph. Eur. definitions. The last preparation described could be considered as finished medicinal product containing an extract (= active substance) corresponding to a "herbal (drug) preparation" definition solubilized in a vegetable oil. However, like "CBD oil", "Cannabis oil" does not correspond to an accurate description of the active substance from a regulatory quality perspective. It could be misleading and should therefore not be used.
More information is available in EMA´s Compilation of terms and definitions for Cannabis-derived medicinal products. The glossary is published under a new subsection of "Guidance documents" (documents adopted by the HMPC relevant for the evaluation by national competent authorities of Cannabis-derived medicinal products) at Herbal medicines: regulatory and scientific support.