The New Ph. Eur. Monographs Cannabis Flower and CBD are now Published

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

The European Pharmacopoeia (Ph. Eur.) Suppl. 11.5 is now available containing the new Ph. Eur. Cannabis Flower monograph (already pre-published in October 2023) and the new Ph. Eur. monograph Cannabidiol (CBD). It is expected that the Ph. Eur. Cannabis flower monograph will replace the currently existing national monographs (NL, DK, D, and CH) as of 1 July 2024 (which is the official implementation date of the Ph. Eur. monograph).

The new Cannabis Flower monograph covers:

• raw material for the production of extracts,
• medicinal products which can be prescribed as is (= herbal drug), to be taken by patients by inhalation or oral administration.

Compared to the draft version, additional requirements have been included in the limits for content, in the production section and in the tests for foreign matter and heavy metals for cases in which the herbal drug is to be prescribed to patients as a medicinal product. The Loss on drying (LOD) limit has been set to max. 12.0 % (in the draft version max. 10.0% was proposed).

The limits for heavy metals (Ph. Eur. 2.4.27) if the herbal drug is to be prescribed to patients as a medicinal product are significantly lower compared to those provided in the general Ph. Eur. monograph Herbal Drugs (due to the potential inhalation use, based on ICH Q3D). Regarding other contaminants, like, for example, mycotoxins, pesticides and microbiological quality (i.e., according to Ph. Eur. 5.1.8 or 5.1.4, depending on the route of administration), it is still required to refer to the general Ph. Eur. monograph Herbal Drugs.

In addition, the Ph. Eur. CBD monograph now clearly defines: CBD is isolated from the Cannabis sativa L. plant. This is different compared to the draft version published in 2022 where it was proposed to define that "CBD is isolated from natural sources". 

More information is available in the European Pharmacopoeia.