HMPC Q&A Documents on Herbal Medicinal Products published

Recommendation

12-14 December 2023

Stability by Design - Live Online Training
- Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products

On 12 May 2014, the EMA's HMPC (Committee on Herbal Medicinal Products) published the Questions & Answers document on (traditional) herbal medicinal products. The document also addresses herbal medicinal products which don't have a European tradition.

The Q&A document contains Questions & Answers about the following topics:

• Regulation of herbal medicinal products in the EU ( (Q&A 1 - 7)
• Specific provisions for traditional herbal medicinal products (Q&A 8 - 17)
• Type and role of monographs in the European framework (Q&A 18 - 21)
• Advice, procedures and relevant institutions (Q&A 22 - 24)

The table included in the answer to question 24 is particularly interesting. There you can find which authorities are responsible for individual decisions. 

For further information please see the complete "Questions & Answers on the EU framework for (traditional) herbal medicinal products, including those from a non-European tradition".