Pascual writes
The European Medicines Agency’s Committee on Herbal Medicinal Products (HMPC) has released a draft public statement—open for consultation from August 1 to October 31, 2025—concluding that an EU herbal monograph for Cannabis sativa L., flos (cannabis flowering tops) cannot currently be established.
Following a data call in early 2023 and a comprehensive review, HMPC outlined the main reasons:
• No authorized single-ingredient products: There are no approved medicinal products in the EU made solely from cannabis flowering tops. Magistral formulas exist in some Member States, but none have been evaluated or approved for specific indications, strengths, or dosages by national authorities.
• Insufficient data for monograph criteria: Submissions failed to meet requirements under the “well-established use” and “traditional use” frameworks. Specifically, the evidence lacked consistency, quality specifications, and the necessary documentation of safety, efficacy, and sustained medicinal use.
• Mandate and scope limitations: HMPC’s remit is restricted to herbal medicinal products. It excludes stand-alone or mixed applications (e.g. under Article 8(3) of Directive 2001/83/EC) and products based on isolated cannabinoids. The only authorized cannabis-derived medicine in the EU is a combination extract product approved since 2011.
Bottom line: HMPC is discontinuing its assessment.
