EMA: No EU Monograph for Cannabis Flowers – New GACP Guidelines Expected

Source: German Cannabis Business Assoc


2025-08-22 | The Herbal Medicinal Products Committee of the EMA stated in a draft that it is currently not possible to create a European monograph for cannabis flowers, reports Business of Cannabis.

Neither are EU-approved medicines based on pure flowers available, nor do existing data meet the criteria for established or traditional use. As a result, there is a lack of uniform quality standards, efficacy, and safety evidence. At the same time, a revision of the guidelines on Good Agricultural and Collection Practice, in effect since 2006, is being prepared, with publication planned for 2025. Experts expect a closer alignment with requirements, clear delineations in post-harvest processing steps, and stricter documentation obligations. Producers will need to provide comprehensive validations and complete evidence, which will require investments and adjustments in the industry.

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