9/10 March 2021
At the beginning of May 2014, the EMA's HMPC (Committee on Herbal Medicinal Products) published the final "Reflection Paper" on quality of essential oils used for the manufacture of herbal medicinal products/traditional herbal medicinal products. The document was adopted on 25 March by the HMPC.
This "Reflection Paper" should help consider aspects related to the nature and the specific production processes of essential oils.
Products with essential oils belong to herbal preparations. So far, the requirements on essential oils hadn't been sufficiently addressed in the existing guidelines.
Moreover, the current HMPC quality guidelines don't take into consideration the definitions of essential oils as laid down in the European Pharmacopoeia (Ph. Eur.).
Essential oils used as API in herbal products lead to - from a regulatory view - a wide range of questions, especially as the current guidelines incompletely depict the specific aspects of essentials oils.
In addition, a Q&A document containing questions and answers on herbal medicinal products/traditional herbal medicinal products was published on 30 April 2014. Four new questions and answers about essential oils have been added to this Q&A document.
For more detailed information please see the complete "Reflection paper on quality of essential oils as active substances in herbal medicinal products/taditional herbal medicinal products" as well as the extended Q&A document "Questions & answers on quality of herbal medicinal products/traditional herbal medicinal products".