Quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products - Scientific guideline

This document considers aspects related to the nature and the specific production processes of essential oils. It provides guidance for manufacturers of essential oils and applicants on the documentation to be presented to the competent authorities. It applies to essential oils used as active substances in herbal medicinal products both for human and veterinary use and in traditional herbal medicinal products for human use.

Keywords: Herbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, essential oils, quality

Current version

Reflection paper on quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products

Adopted Reference Number: EMA/HMPC/84789/2013 Summary:

This reflection paper applies to essential oils used as active substances in herbal medicinal products (HMPs) both for human and veterinary use and in traditional herbal medicinal products (THMPs) for human use.

Document history - First version (current)

Reflection paper on quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products

Adopted Reference Number: EMA/HMPC/84789/2013 Summary:

This reflection paper applies to essential oils used as active substances in herbal medicinal products (HMPs) both for human and veterinary use and in traditional herbal medicinal products (THMPs) for human use.

Draft reflection paper on quality of essential oils as active substances in herbal medicinal products / traditional herbal medicinal products

Draft: consultation closed Consultation dates: 15/02/2013 to 15/05/2013 Reference Number: EMA/HMPC/84789/2013 Summary:

This reflection paper applies to essential oils used as active substances in herbal medicinal products both for human and veterinary use and in traditional herbal medicinal products for human use. The purpose of this reflection paper is to consider aspects related to the nature and the specific production processes of essential oils. The aim is to provide further guidance for manufacturers of essential oils and applicants on the documentation to be presented to the competent authorities.