Microbiological aspects of herbal medicinal products and traditional herbal medicinal products - Scientific guideline
Table of contents
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
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Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products (PDF/263.68 KB)
Adopted
First published: 05/06/2015
Last updated: 05/06/2015
EMA/HMPC/95714/2013 -
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Overview of comments received on ‘Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products’ (PDF/168.04 KB)
First published: 05/06/2015
Last updated: 05/06/2015
EMA/HMPC/130616/2015 -
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Draft reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products (PDF/289.9 KB)
Draft: consultation closed
First published: 19/02/2014
Last updated: 19/02/2014
Consultation dates: 19/02/2014 to 15/06/2014
EMA/HMPC/95714/2013