Use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products/traditional herbal medicinal products - Scientific guideline

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

Current version

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

AdoptedReference Number: EMA/HMPC/453258/2013Summary:

This reflection paper 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).

Document history - First version (current)

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

AdoptedReference Number: EMA/HMPC/453258/2013Summary:

This reflection paper 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).

Concept paper on use of recovered / recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products

Consultation dates: 15/02/2013 to 15/05/2013Draft: consultation closedReference Number: EMA/HMPC/13658/2013Summary:

This concept paper concerns the standards to be applied to recycled or recovered solvents used for extraction of herbal substances in the manufacture of herbal preparations for use in herbal medicinal products and traditional herbal medicinal products.