News
EMA: Draft reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products
20.02.2014
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
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EMA: This concept paper is concerned with the revision of the clinical and non-clinical sections of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a registration application for traditional herbal medicinal pr
05.12.2013
This concept paper is concerned with the revision of the clinical and non-clinical sections of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a
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EMA: 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
05.12.2013
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)/
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EMA: Second draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)
21.11.2013
It became apparent during assessment of Symphytum officinale (monograph EMEA/HMPC/572844/2009) that the risk assessment of pyrrolizidine alkaloids (PAs) poses considerable difficulties, with
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EMA: Guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal products
16.05.2013
This document aims to provide guidance on how to present the application for registration of traditional herbal medicinal products (THMPs) in the Common Technical Document (CTD) format, providing
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EMA: Reflection paper on quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products - Draft
07.03.2013
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)
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EMA: Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products
09.08.2012
This document aims to provide guidance on how to present the application for registration of traditional herbal medicinal products (THMPs) in the Common Technical Document (CTD) format, providing
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EMA: Concept paper on non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products / traditional herbal medicinal products
05.07.2012
This concept paper applies to non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products (HMPs) / traditional herbal medicinal products (THMPs). ...
EMA: Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population
01.03.2012
The aim of this document is to highlight the lack of clinical studies on the majority of herbal medicinal products in children and the need for initiatives to stimulate the conduct of clinical
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EMA: Committee on Herbal Medicinal Products approves four-year work programme
22.12.2011
The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency has approved a work programme for 2012-2015 with the aim of strengthening the integration of herbal medicines in
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