Use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products/traditional herbal medicinal products - Scientific guideline
Table of contents
This document concerns the use of recycled/recovered solvents for extraction of herbal substances in the manufacture of herbal preparations for use in herbal medicinal products (HMPs)/traditional herbal medicinal products (THMPs). It aims to provide clarification on the issues to be addressed and the documentation which should be submitted in order to assist applicants in developing dossiers for HMPs/THMPs.
Keywords: Herbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extraction solvents, recovered/recycled solvents, quality
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Reflection paper on the use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products (PDF/116.35 KB)
Adopted
First published: 03/12/2013
Last updated: 03/12/2013
EMA/HMPC/453258/2013 -
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Concept paper on use of recovered / recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products (PDF/113.4 KB)
Draft: consultation closed
First published: 01/03/2013
Last updated: 01/03/2013
Consultation dates: 15/02/2013 to 15/05/2013
EMA/HMPC/13658/2013