Microbiological aspects of herbal medicinal products and traditional herbal medicinal products - Scientific guideline

This document aims to provide an overview of the critical aspects to be taken into account to ensure suitable microbial quality of herbal substances, herbal preparations and herbal medicinal products. Methods of sterilisation and the microbiological quality of herbal substances, herbal preparations and herbal medicinal products for sterile dosage forms are not covered by this paper.

Keywords: Herbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, quality, microbiological aspects, microbial decontamination

Current version

Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products

Adopted Reference Number: EMA/HMPC/95714/2013

Document history - First version (current)

Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products

Adopted Reference Number: EMA/HMPC/95714/2013

Overview of comments received on ‘Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products’

Reference Number: EMA/HMPC/130616/2015

Draft reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products

Draft: consultation closed Consultation dates: 19/02/2014 to 15/06/2014 Reference Number: EMA/HMPC/95714/2013 Summary:

Directive 2001/83/EC as amended and Directive 2001/82/EC as amended provide definitions for herbal substances, herbal preparations, and herbal medicinal products (HMPs). The basic legislation applies to both HMPs for human and veterinary use. An additional simplified registration procedure has been established for traditional herbal medicinal products (THMPs) for human use under Directive 2004/24/EC. The principles of this reflection paper apply equally to such THMPs.