Draft Public Statement on Cannabis Flos

The draft public statement on Cannabis sativa L. has been published. The HMPC currently believes that it is not possible to establish a European Union herbal monograph on Cannabis Flower. The public consultation is open until 31 October 2025.

Are the Requirements for Well-Established or Traditional Use Fulfilled?

To foster a more harmonized approach in the presentation and manufacture of Cannabis-derived medicinal products, the European Commission (EC) requested that the Committee on Herbal Medicinal Products (HMPC) compiles a list of terms and definitions and also suggested exploring the feasibility of establishing an EU herbal monograph on Cannabis sativa L., flos.

Different preparations obtained from Cannabis sativa L., flos can be found in some EU Member States as "magistral formulations". While “medicinal use” in the context of well-established use (WEU) does not exclusively refer to “use as an authorized medicinal product”, data generated from magistral formulations cannot substitute the requirement to demonstrate a systematic and documented use within the Union for a period of 10 years. As the preparations differ, a single product with consistent, defined specifications and quality was unavailable for efficacy and safety assessment, so the HMPC did not consider the WEU requirements to be met..

In summary, the HMPC concluded that the requirements for the establishment of an EU herbal monograph on traditional and/or well-established use for herbal medicinal products containing Cannabis sativa L., flos are not fulfilled.

More information is available in the draft Public statement on Cannabis sativa L., flos, published on the EMA's website.