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Scope of these Q&A

These Q&A aim at clarifying regulatory requirements to obtain a marketing authorisation 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.

More detailed information can be found on various places at the EMA website: 

  • https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation
  • https://www.ema.europa.eu/en/human-regulatory/herbal-medicinal-products
  • https://www.ema.europa.eu/en/human-regulatory/herbal-products/european-unionmonographs-list-entries

These Q&A focus on the EU framework for medicinal products and is without prejudice to additional national requirements that may apply to Cannabis-derived products