Public consultation for reflection paper on particulars for safety signals for (traditional) herbal medicinal products

22nd July 2026

The European Medicines Agency has published for public consultation a draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products.

This reflection paper discusses particular aspects to be considered for safety signals for herbal medicinal products, including traditional herbal medicinal products, in addition to established EMA guidance documents. It should be read in conjunction with Directive 2001/83/EC, Regulation (EC) No 726/2004 and Commission Implementing Regulation (EU) No 520/2012, as well as relevant guidelines on GVP. The guidance published as GVP is the principal guidance supporting implementation of, and compliance with, legal requirements.

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Comments should be provided by 15 October 2026 using this template.

The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public and targeted consultations.

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