Herbal medicinal products: Regulatory and procedural guidance

General

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Guidance for companies seeking scientific support and advice on traditional herbal medicinal products (PDF/135.1 KB)

Adopted

First published: 20/07/2011
Last updated: 09/03/2012
Consultation dates: 12/07/2011 to 15/11/2011
EMA/HMPC/127670/2011
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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 (PDF/70.96 KB)

Draft: consultation closed

First published: 01/06/2011
Last updated: 01/06/2011
Consultation dates: 31/03/2011 to 15/09/2011
EMA/HMPC/111298/2011
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Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1 (PDF/312.96 KB)

Draft: consultation closed

First published: 08/08/2012
Last updated: 08/08/2012
Consultation dates: 08/08/2012 to 15/10/2012
EMA/HMPC/71049/2007 Rev. 1
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Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - First version (PDF/119.09 KB)

Adopted

First published: 10/01/2008
Last updated: 10/01/2008
Legal effective date: 10/01/2008
EMEA/HMPC/71049/2007
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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 (PDF/73.48 KB)

First published: 10/01/2008
Last updated: 10/01/2008
EMEA/HMPC/539645/2007
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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) (PDF/53.75 KB)

Adopted

First published: 07/09/2006
Last updated: 07/09/2006
EMEA/HMPC/431129/2005
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Concept paper on CTD for traditional herbal medicinal products (PDF/146.31 KB)

Adopted

First published: 09/03/2006
Last updated: 09/03/2006
EMEA/HMPC/261344/2005
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HMPC statement on environmental risk assessment of herbal medicinal products (PDF/51.77 KB)

Adopted

First published: 28/04/2010
Last updated: 28/04/2010
EMA/HMPC/121934/2010
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Public statement on the interpretation of the term 'external use' for use in the field of traditional herbal medicinal products (PDF/136.43 KB)

Adopted

First published: 12/05/2006
Last updated: 12/05/2006
EMEA/HMPC/31897/2006
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Public statement on the interpretation of therapeutic indications appropriate to traditional herbal medicinal products in Community herbal monographs (PDF/66.86 KB)

Adopted

First published: 29/09/2011
Last updated: 29/09/2011
EMA/HMPC/473587/2011
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Public Statement on CPMP List of Herbal Drugs with serious risks, dated 1992 (PDF/81.38 KB)

Adopted

First published: 23/11/2005
Last updated: 23/11/2005
EMEA/HMPC/246736/2005
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Regulatory questions and answers on herbal medicinal products (PDF/252.97 KB)

First published: 22/03/2011
Last updated: 02/08/2021
EMA/HMPC/345132/2010 Rev.5
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Template for submission of a request for scientific support and advice on a traditional herbal medicinal product (DOC/228 KB)

Adopted

First published: 24/10/2005
Last updated: 17/11/2014
EMEA/HMPC/119889/2005 Rev. 1 Corr.
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Template for submission of a request for scientific support and advice on a traditional herbal medicinal product (PDF/116.22 KB)

First published: 24/10/2005
Last updated: 17/11/2014
EMEA/HMPC/119889/2005 Rev. 1 Corr

Herbal medicinal products: Regulatory and procedural guidance

Table of contents

General

Guidance for companies seeking scientific support and advice on traditional herbal medicinal products (PDF/135.1 KB)

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 (PDF/70.96 KB)

Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1 (PDF/312.96 KB)

Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - First version (PDF/119.09 KB)

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 (PDF/73.48 KB)

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) (PDF/53.75 KB)

Concept paper on CTD for traditional herbal medicinal products (PDF/146.31 KB)

HMPC statement on environmental risk assessment of herbal medicinal products (PDF/51.77 KB)

Public statement on the interpretation of the term 'external use' for use in the field of traditional herbal medicinal products (PDF/136.43 KB)

Public statement on the interpretation of therapeutic indications appropriate to traditional herbal medicinal products in Community herbal monographs (PDF/66.86 KB)

Public Statement on CPMP List of Herbal Drugs with serious risks, dated 1992 (PDF/81.38 KB)

Regulatory questions and answers on herbal medicinal products (PDF/252.97 KB)

Template for submission of a request for scientific support and advice on a traditional herbal medicinal product (DOC/228 KB)

Template for submission of a request for scientific support and advice on a traditional herbal medicinal product (PDF/116.22 KB)

Community List and Monographs

Procedure for the systematic review of European Union herbal monographs and/or European Union list entries and supporting documents (PDF/119.76 KB)

Template for submission by Committee on Herbal Medicinal Products (HMPC) members or national competent authorities of questions for discussion by the HMPC (DOC/137.5 KB)

Template for submission by Committee on Herbal Medicinal Products (HMPC) members or national competent authorities of questions for discussion by the HMPC (PDF/105.45 KB)

Glossary on herbal teas (PDF/87.69 KB)

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 (PDF/146.3 KB)

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 a... (PDF/70.83 KB)

Draft procedure on the publication of HMPC public statements when Community herbal monographs on herbal substances, preparations and/or combinations thereof are not established (PDF/116.23 KB)

Template for a public statement when no European Union herbal monograph is established (DOC/238.5 KB)

Template for a public statement when no Community herbal monograph is established (PDF/84.42 KB)

Template for information exchange for the preparation of the assessment report supporting the establishment of European Union monographs and European Union list entries - Revision 1 (DOC/180 KB)

Procedure for calls for scientific data for use in HMPC assessment work (PDF/156.92 KB)

Overview of comments received on HMPC draft procedure for calls for scientific data for use in HMPC assessment work (EMEA/HMPC/1004/2006) (PDF/45.02 KB)

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 (PDF/50.27 KB)

Timelines for the establishment of a European Union herbal monograph and/or a European Union list entry (PDF/113.8 KB)

Procedure for the preparation of Community monographs for traditional herbal medicinal products (PDF/85.57 KB)

Procedure for the preparation of Community monographs for herbal medicinal products with well-established medicinal use (PDF/80.73 KB)

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' (PDF/82.5 KB)

Procedure on management of proposals submitted by interested parties for Community list entries or Community herbal monographs - Revision 1 (PDF/60.57 KB)

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) - Revision 1 (PDF/47.1 KB)

Matching patients-friendly therapeutic areas for browse search on herbal medicines for human use with ATC therapeutic groups (level 2) (PDF/79.7 KB)

Template for assessment report for the development of European Union herbal monographs and European Union list entries (DOC/362.5 KB)

Template for assessment report for the development of European Union herbal monographs and European Union list entries (PDF/192.42 KB)

Template and recommended format for list of references (PDF/68.06 KB)

Template and recommended format for list of references (DOT/322.5 KB)

Structure of the list of herbal substances, preparations and combinations thereof (PDF/83.75 KB)

Overview of comments received on structure of the list of herbal substances, preparations and combinations thereof (EMEA/HMPC/100824/2005) (PDF/131.37 KB)

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' (PDF/48.78 KB)

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) (PDF/36.96 KB)

Template for a European Union list entry (DOC/167 KB)

Template for a European Union list entry (PDF/107.66 KB)

Template for a European Union herbal monograph (DOC/265 KB)

Template for a European Union herbal monograph (PDF/189.27 KB)

Template for submission of comments on draft European Union herbal monograph or draft European Union list entry (DOC/330.5 KB)

Template for overview of comments received on on draft European Union herbal monograph or European Union list entry (DOC/160 KB)

Inventory of herbal substances for assessment (PDF/615.75 KB)

HMPC: overview of assessment work - priority list (PDF/771.94 KB)

Reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries (PDF/113.87 KB)

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) (PDF/52.73 KB)

Standard operating procedure on establishment of Community herbal monographs, Community list entries and related documents (PDF/341.23 KB)

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