Questions & Answers Regarding Cannabis-derived Medicinal Products and the Scope of EU Herbal Monographs for Herbal Medicinal Products within the EU Medicines Legislation

15 February 2023 – the EMA published Q&A guidance on herbal medicinal products.

These Q&A aim at clarifying regulatory requirements to obtain a marketing authorization for medicinal products in the EU (Q1) and at explaining the work of Committee on Herbal Medicinal Products (HMPC) regarding EU herbal monographs (Q2, Q3), as stakeholders involved in the manufacturing of Cannabis-derived substances may not have extensive experience with the EU pharmaceutical regulatory system.

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