HMPC Q&A Documents on Herbal Medicinal Products published
![Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals - Live Online Training](files/eca/userImages/training.img/Z-ECA-Stability-Studies-Shipping-Distribution-LOT.jpg)
Recommendation
12/13 September 2024
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".
Related GMP News
24.07.2024FDA Warning Letter to Chinese OTC Manufacturer for Lack of Analytical Test Data
10.07.2024Pharmeuropa: Two Revised Chapters on Dissolution Testing published for comments
03.07.2024FDA Warning Letter: GMP Requirements also apply to HPLC Analyses for Internal Use
12.06.2024NMPA Announcement on Application of ICH Q2(R2) and Q14 Principles
22.05.2024Q&As from the Live Online Training "Introduction to the AQCG's new AIQSV Guide" - Part 1
22.05.2024FDA Warning Letter to Contract Testing Laboratory in Uruguay due to Data Integrity Violations