Quality: Herbal medicinal products

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Questions and answers on quality of herbal medicinal products / traditional herbal medicinal productsQuestions and answersEMEA/HMPC/41500/2010 Rev. 5April 2015  
Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products

Overview of comments

Reflection paper

Draft reflection paper

 EMA/HMPC/95714/2013June 2015  
Quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products

Reflection paper

Draft reflection paper

EMEA/HMPC/84789/2013May 2014  
Reflection paper on the use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal productsReflection paperEMEA/HMPC/453258/2013Dec 2013  
Use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal productsConcept paperEMEA/HMPC/13658/2013Release for consultation Feb 2013 Deadline for comments 15 May 2013
Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal productsOverview of comments
Adopted guideline
Draft guideline
EMEA/HMPC/3626/09Nov 2010  
Reflection paper on level of purification of extracts to be considered as herbal preparations

Overview of comments

Adopted guideline

Concept paper

EMEA/HMPC/186645/08Jan 2011Sep 2010 
Development of a guideline on preparation on herbal teasConcept paperEMEA/HMCP/451978/08Release for consultation Sep 2008 Deadline for comments 15 Jan 2009
Markers used for quantitative and qualitative analysis of Herbal Medicinal Products and traditional Herbal Medicinal Products

Overview of comments

Adopted guideline

Draft guideline

EMEA/HMPC/253629/07Jul 2008  
Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC

Overview of comments

Adopted guideline

Draft guideline

EMEA/HMPC/CHMP/CVMP/287539/05 Rev. 1Apr 2010 Oct 2010 
Quality of Combination Herbal Medicinal Products / Traditional Herbal Medicinal Products

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMEA/HMPC/CHMP/CVMP/214869/06Jun 2008Nov 2008 
Non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products / traditional herbal medicinal productsConcept paperEMA/HMPC/312890/2012Release for consultation June 2012 Deadline for comments 15 Oct 2012
Revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal productsConcept paperHMPC/217631/2015Release for consultation 1 June 2015 Deadline for comments 31 august 2015
Quality of Herbal Medicinal Products/Traditional Herbal Medicinal ProductsAdopted guidelineCPMP/QWP/2819/00 Rev. 2Sep 2011  
Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products

Overview of comments

Adopted guideline

CPMP/QWP/2819/00 Rev. 1Oct 2006  
Revision of the guideline on specifications: Test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal productsConcept paperHMPC/217753/2015Release for consultation 1 June 2015 Deadline for comments 31 august 2015
Test procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products / Traditional Herbal Medicinal ProductsAdopted guidelineCPMP/QWP/2820/00 Rev. 2Sep 2011  
Test procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products / Traditional Herbal Medicinal Products

Overview of comments

Adopted guideline

CPMP/QWP/2820/00 Rev. 1Oct 2006  
The use of FumigantsAdopted guidelineEMEA/HMPC/125562/06Oct 2006  
Good Agricultural and Collection Practice for starting materials of Herbal Origin

Overview of comments

Adopted guideline

EMEA/HMPC/246816/05Jul 2005Aug 2006 

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