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 20/07/2011 09/03/2012  
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 01/06/2011    
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 08/08/2012    
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 10/01/2008   10/01/2008
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)   10/01/2008    
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 07/09/2006    
Concept paper on CTD for traditional herbal medicinal products (English only) adopted 09/03/2006    
HMPC statement on environmental risk assessment of herbal medicinal products (English only) adopted 28/04/2010    
Public statement on the interpretation of the term 'external use' for use in the field of traditional herbal medicinal products (English only) adopted 12/05/2006    
Public statement on the interpretation of therapeutic indications appropriate to traditional herbal medicinal products in Community herbal monographs (English only) adopted 29/09/2011    
Public Statement on CPMP List of Herbal Drugs with serious risks, dated 1992 (English only) adopted 23/11/2005    
Regulatory questions and answers on herbal medicinal products (English only)   22/03/2011 07/06/2013  
Template for submission of a request for scientific support and advice on a traditional herbal medicinal product (English only) adopted 24/10/2005 17/11/2014  
Template for submission of a request for scientific support and advice on a traditional herbal medicinal product (English only)   24/10/2005 17/11/2014  

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 20/07/2011 20/04/2015  
Template for submission by Committee on Herbal Medicinal Products (HMPC) members or national competent authorities of questions for discussion by the HMPC (English only)   20/07/2011 17/11/2014  
Template for submission by Committee on Herbal Medicinal Products (HMPC) members or national competent authorities of questions for discussion by the HMPC (English only)   20/07/2011 17/11/2014  
Glossary on herbal teas (English only)   28/04/2010 03/01/2011  
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 20/07/2011 13/02/2014  
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)   20/07/2011    
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 16/02/2011    
Template for a public statement when no European Union herbal monograph is established (English only)   20/07/2011 17/11/2014  
Template for a public statement when no Community herbal monograph is established (English only)   16/02/2011 17/11/2014  
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)   20/07/2011 17/11/2014  
Procedure for calls for scientific data for use in HMPC assessment work (English only) adopted 12/03/2009 13/06/2016  
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)   26/10/2006    
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 12/03/2009    
Timelines for the establishment of a European Union herbal monograph and/or a European Union list entry (English only) adopted 08/03/2007 07/11/2014  
Procedure for the preparation of Community monographs for traditional herbal medicinal products (English only) adopted 11/01/2007    
Procedure for the preparation of Community monographs for herbal medicinal products with well-established medicinal use (English only) adopted 11/01/2007    
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 05/07/2007    
Procedure on management of proposals submitted by interested parties for Community list entries or Community herbal monographs (English only) adopted 12/11/2009    
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)   08/05/2008    
Matching patients-friendly therapeutic areas for browse search on herbal medicines for human use with ATC therapeutic groups (level 2) (English only) adopted 28/06/2011 08/03/2016  
Template for assessment report for the development of European Union herbal monographs and European Union list entries (English only) adopted 06/11/2008 17/11/2014  
Template for assessment report for the development of European Union herbal monographs and European Union list entries (English only) adopted 06/11/2008 17/11/2014  
Template and recommended format for list of references (English only) adopted 16/07/2009 17/11/2014  
Template and recommended format for list of references (English only) adopted 16/07/2009 17/11/2014  
Structure of the list of herbal substances, preparations and combinations thereof (English only) adopted 13/07/2006    
Overview of comments received on structure of the list of herbal substances, preparations and combinations thereof (EMEA/HMPC/100824/2005) (English only)   24/10/2005    
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 05/07/2007    
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)   24/10/2007    
Template for a European Union list entry (English only) adopted 06/03/2008 17/11/2014  
Template for a European Union list entry (English only) adopted 06/03/2008 17/11/2014  
Template for a European Union herbal monograph (English only) adopted 16/07/2009 17/11/2014  
Template for a European Union herbal monograph (English only) adopted 16/07/2009 17/11/2014  
Template for submission of comments on draft European Union herbal monographor draft European Union list entry (English only)   03/04/2009 24/07/2014  
Template for overview of comments received on on draft European Union herbal monograph or European Union list entry (English only) adopted 03/04/2009 17/11/2014  
Inventory of herbal substances for assessment (English only) adopted 25/10/2009 16/10/2015  
HMPC: overview of assessment work – priority list (English only) adopted 25/10/2009 22/07/2016  
Reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries (English only) adopted 04/09/2008 09/03/2012  
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)   04/09/2008    
Standard operating procedure on establishment of Community herbal monographs, Community list entries and related documents (English only) adopted 07/05/2009 21/02/2013 20/02/2013