Herbal medicinal products: Regulatory and procedural guidance

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General

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Document(s) Language Status First published Last updated Effective Date
Guidance for companies seeking scientific support and advice on traditional herbal medicinal products (English only) adopted 2011-07-20 2012-03-09  
Concept paper on the revision of the guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1 (English only) draft: consultation closed 2011-06-01    
Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1 (English only) draft: consultation closed 2012-08-08    
Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - First version (English only) adopted 2008-01-10   2008-01-10
Overview of comments received on draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - First version (English only)   2008-01-10    
Guidance on documentation to be provided by member states and applicants/MAHS in support of a simplified registration referral under articles 16c(1)c and 16c(4) (English only) adopted 2006-09-07    
Concept paper on CTD for traditional herbal medicinal products (English only) adopted 2006-03-09    
HMPC statement on environmental risk assessment of herbal medicinal products (English only) adopted 2010-04-28    
Public statement on the interpretation of the term 'external use' for use in the field of traditional herbal medicinal products (English only) adopted 2006-05-12    
Public statement on the interpretation of therapeutic indications appropriate to traditional herbal medicinal products in Community herbal monographs (English only) adopted 2011-09-29    
Public Statement on CPMP List of Herbal Drugs with serious risks, dated 1992 (English only) adopted 2005-11-23    
Regulatory questions and answers on herbal medicinal products (English only)   2011-03-22 2013-06-07  
Template for submission of a request for scientific support and advice on a traditional herbal medicinal product (English only) adopted 2005-10-24 2014-11-17  
Template for submission of a request for scientific support and advice on a traditional herbal medicinal product (English only)   2005-10-24 2014-11-17  

Community List and Monographs

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Document(s) Language Status First published Last updated Effective Date
Procedure for the systematic review of European Union herbal monographs and/or European Union list entries and supporting documents (English only) adopted 2011-07-20 2015-04-20  
Template for submission by Committee on Herbal Medicinal Products (HMPC) members or national competent authorities of questions for discussion by the HMPC (English only)   2011-07-20 2014-11-17  
Template for submission by Committee on Herbal Medicinal Products (HMPC) members or national competent authorities of questions for discussion by the HMPC (English only)   2011-07-20 2014-11-17  
Glossary on herbal teas (English only)   2010-04-28 2011-01-03  
Procedure on the publication of Committee on Herbal Medicinal Products public statements when Community herbal monographs on herbal substances, preparations and/or combinations thereof are not established (English only) adopted 2011-07-20 2014-02-13  
Overview of comments received on 'Procedure on the publication of Committee on Herbal Medicinal Products public statements when Community herbal monographs on herbal substances, preparations and/or combinations thereof are not established' (English only)   2011-07-20    
Draft procedure on the publication of HMPC public statements when Community herbal monographs on herbal substances, preparations and/or combinations thereof are not established (English only) draft: consultation closed 2011-02-16    
Template for a public statement when no European Union herbal monograph is established (English only)   2011-07-20 2014-11-17  
Template for a public statement when no Community herbal monograph is established (English only)   2011-02-16 2014-11-17  
Template for information exchange for the preparation of the assessment report supporting the establishment of European Union monographs and European Union list entries (English only)   2011-07-20 2014-11-17  
Procedure for calls for scientific data for use in HMPC assessment work (English only) adopted 2009-03-12 2016-06-13  
Overview of comments received on HMPC draft procedure for calls for scientific data for use in HMPC assessment work (EMEA/HMPC/1004/2006) (English only)   2006-10-26    
Procedure for the appointment by the HMPC of a rapporteur responsible for a scientific evaluation or the establishment of a Community herbal monograph and / or Community list entry (English only) adopted 2009-03-12    
Timelines for the establishment of a European Union herbal monograph and/or a European Union list entry (English only) adopted 2007-03-08 2014-11-07  
Procedure for the preparation of Community monographs for traditional herbal medicinal products (English only) adopted 2007-01-11    
Procedure for the preparation of Community monographs for herbal medicinal products with well-established medicinal use (English only) adopted 2007-01-11    
Procedure for the preparation of an entry to the 'Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products' (English only) adopted 2007-07-05    
Procedure on management of proposals submitted by interested parties for Community list entries or Community herbal monographs (English only) adopted 2009-11-12    
Overview of comments received on procedure on management of proposals submitted by interested parties for community list entries or community herbal monographs (EMEA/HMPC/328575/2007) (English only)   2008-05-08    
Matching patients-friendly therapeutic areas for browse search on herbal medicines for human use with ATC therapeutic groups (level 2) (English only) adopted 2011-06-28 2016-03-08  
Template for assessment report for the development of European Union herbal monographs and European Union list entries (English only) adopted 2008-11-06 2014-11-17  
Template for assessment report for the development of European Union herbal monographs and European Union list entries (English only) adopted 2008-11-06 2014-11-17  
Template and recommended format for list of references (English only) adopted 2009-07-16 2014-11-17  
Template and recommended format for list of references (English only) adopted 2009-07-16 2014-11-17  
Structure of the list of herbal substances, preparations and combinations thereof (English only) adopted 2006-07-13    
Overview of comments received on structure of the list of herbal substances, preparations and combinations thereof (EMEA/HMPC/100824/2005) (English only)   2005-10-24    
Guideline on the documentation to be submitted for inclusion into the 'community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products' (English only) adopted 2007-07-05    
Overview of comments received on guideline on the documentation to be submitted for inclusion in the List of herbal substances, preparations and combinations thereof (EMEA/HMPC/107399/2005) (English only)   2007-10-24    
Template for a European Union list entry (English only) adopted 2008-03-06 2014-11-17  
Template for a European Union list entry (English only) adopted 2008-03-06 2014-11-17  
Template for a European Union herbal monograph (English only) adopted 2009-07-16 2014-11-17  
Template for a European Union herbal monograph (English only) adopted 2009-07-16 2014-11-17  
Template for submission of comments on draft European Union herbal monographor draft European Union list entry (English only)   2009-04-03 2014-07-24  
Template for overview of comments received on on draft European Union herbal monograph or European Union list entry (English only) adopted 2009-04-03 2014-11-17  
Inventory of herbal substances for assessment (English only) adopted 2009-10-25 2015-10-16  
HMPC: overview of assessment work – priority list (English only) adopted 2009-10-25 2016-10-18  
Reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries (English only) adopted 2008-09-04 2012-03-09  
Overview of comments received on reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries (EMEA/HMPC/326440/2008) (English only)   2008-09-04    
Standard operating procedure on establishment of Community herbal monographs, Community list entries and related documents (English only) adopted 2009-05-07 2016-10-03 2016-09-27