Revised Ph. Eur. Cannabis Monograph

A revised version of the Ph. Eur. Cannabis Flower Monograph has just been published in Pharmeuropa 37.4. The comment deadline is 31 December 2025. Amongst others, the additional acceptance criteria for seeds and leaves for the herbal drug when prescribed to patients as a medicinal product were widened (Foreign matter).

Revised Sections

Identification Test C (High-performance thin-layer chromatography, HPTLC): The acceptance criterion for the HPTLC zone for delta-9-tetrahydrocannabinol (THC) for the THC-dominant type is widened. This is to include cases where this zone may be very faint or even absent. As THC mainly originates from the degradation of the corresponding acid (THCA), THC-dominant types tested shortly after being harvested and dried may contain THC contents that are undetectable by the HPTLC procedure.

Foreign matter: Additional acceptance criteria for seeds and leaves for the herbal drug when prescribed to patients as a medicinal product are widened (max. 2 per cent; if the herbal drug is to be prescribed to patients as a medicinal product, it does not contain any mature seeds). Immature seeds appear to be relatively common in Cannabis Flos in some member states where this herbal drug is prescribed to patients. The presence of leaves more than 1.0 cm in length is also not rare in whole trimmed Cannabis Flower similarly prescribed. Accordingly, leaves are foreign organs and, therefore, excessive leaf content is already controlled by the general maximum limit of 2 per cent, as set out in the general Ph. Eur. chapter 2.8.2. Foreign Matter.

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