Herbal medicinal products: Regulatory and procedural guidance

General

Guidance for companies seeking scientific support and advice on traditional herbal medicinal products

Consultation dates: 12/07/2011 to 15/11/2011AdoptedReference Number: EMA/HMPC/127670/2011

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

Consultation dates: 31/03/2011 to 15/09/2011Draft: consultation closedReference Number: EMA/HMPC/111298/2011

Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1

Consultation dates: 08/08/2012 to 15/10/2012Draft: consultation closedReference Number: EMA/HMPC/71049/2007 Rev. 1Summary:

This document aims to provide guidance on how to present the application for registration of traditional herbal medicinal products in the Common Technical Document format, providing information to help applicants in their submissions.

Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - First version

AdoptedLegal effective date: 10/01/2008Reference Number: EMEA/HMPC/71049/2007

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

Reference Number: EMEA/HMPC/539645/2007

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)

AdoptedReference Number: EMEA/HMPC/431129/2005

Concept paper on CTD for traditional herbal medicinal products

AdoptedReference Number: EMEA/HMPC/261344/2005

HMPC statement on environmental risk assessment of herbal medicinal products

AdoptedReference Number: EMA/HMPC/121934/2010

Public statement on the interpretation of the term 'external use' for use in the field of traditional herbal medicinal products

AdoptedReference Number: EMEA/HMPC/31897/2006

Public statement on the interpretation of therapeutic indications appropriate to traditional herbal medicinal products in Community herbal monographs

AdoptedReference Number: EMA/HMPC/473587/2011

Public Statement on CPMP List of Herbal Drugs with serious risks, dated 1992

AdoptedReference Number: EMEA/HMPC/246736/2005

Regulatory questions and answers on herbal medicinal products

Reference Number: EMA/HMPC/345132/2010 Rev.5

Template for submission of a request for scientific support and advice on a traditional herbal medicinal product

AdoptedReference Number: EMEA/HMPC/119889/2005 Rev. 1 Corr.

Template for submission of a request for scientific support and advice on a traditional herbal medicinal product

Reference Number: EMEA/HMPC/119889/2005 Rev. 1 Corr

• Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
• EMA webpage on herbal medicinal products

Community List and Monographs

Procedure for the systematic review of European Union herbal monographs and/or European Union list entries and supporting documents

Consultation dates: 12/07/2011 to 15/11/2011AdoptedReference Number: EMA/HMPC/124695/2011 Rev.1

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

Reference Number: EMA/HMPC/463090/2011 Corr.

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

Reference Number: EMA/HMPC/463090/2011 Corr

Glossary on herbal teas

Reference Number: EMA/HMPC/5829/2010 Rev. 1

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

AdoptedReference Number: EMA/HMPC/84530/2010 Rev. 2

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...

Reference Number: EMA/HMPC/495353/2011

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

Consultation dates: 15/02/2011 to 15/05/2011Draft: consultation closedReference Number: EMA/HMPC/84530/2010

Template for a public statement when no European Union herbal monograph is established

Reference Number: EMA/HMPC/75972/2010 Rev. 1 Corr. 1

Template for a public statement when no Community herbal monograph is established

Consultation dates: 15/02/2011 to 15/05/2011Reference Number: EMA/HMPC/75972/2010 Rev. 1 Corr.1

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

Reference Number: EMEA/HMPC/137093/2006 Rev. 1 Corr.

Procedure for calls for scientific data for use in HMPC assessment work

AdoptedReference Number: EMEA/HMPC/1004/2006 Rev.6

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

Reference Number: EMEA/HMPC/309487/2006

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

AdoptedReference Number: EMEA/HMPC/108877/2005 Rev.1

Timelines for the establishment of a European Union herbal monograph and/or a European Union list entry

AdoptedReference Number: EMEA/HMPC/126542/2005 Rev.2 Corr.

Procedure for the preparation of Community monographs for traditional herbal medicinal products

AdoptedReference Number: EMEA/HMPC/182320/2005 Rev. 2

Procedure for the preparation of Community monographs for herbal medicinal products with well-established medicinal use

AdoptedReference Number: EMEA/HMPC/182352/2005 Rev. 2

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'

AdoptedReference Number: EMEA/HMPC/57137/2007

Procedure on management of proposals submitted by interested parties for Community list entries or Community herbal monographs - Revision 1

AdoptedReference Number: EMEA/HMPC/328575/2007 Rev.1

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

Reference Number: EMEA/HMPC/191615/2008

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

AdoptedReference Number: EMA/568320/2009 Rev. 1Summary:

Understanding the EMA website search tool ‘browse by use’

Template for assessment report for the development of European Union herbal monographs and European Union list entries

AdoptedReference Number: EMEA/HMPC/418902/2005 Rev. 5

Template for assessment report for the development of European Union herbal monographs and European Union list entries

AdoptedReference Number: EMEA/HMPC/418902/2005 Rev. 5, Corr.1

Template and recommended format for list of references

AdoptedReference Number: EMEA/HMPC/574496/2008 Rev. 2 Corr.

Template and recommended format for list of references

AdoptedReference Number: EMEA/HMPC/574496/2008 Rev. 2 Corr.

Structure of the list of herbal substances, preparations and combinations thereof

AdoptedReference Number: EMEA/HMPC/100824/2005 Revision 1

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

Reference Number: EMEA/HMPC/309366/2005

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'

AdoptedReference Number: EMEA/HMPC/107399/2005 Rev. 1

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)

Reference Number: EMEA/HMPC/309367/2005

Template for a European Union list entry

AdoptedReference Number: EMA/HMPC/439705/2006 Rev. 5

Template for a European Union list entry

AdoptedReference Number: EMA/HMPC/439705/2006 Rev. 5

Template for a European Union herbal monograph

AdoptedReference Number: EMEA/HMPC/107436/2005 Rev. 7

Template for a European Union herbal monograph

AdoptedReference Number: EMEA/HMPC/107436/2005 Rev. 7, Corr. 1

Template for submission of comments on draft European Union herbal monograph or draft European Union list entry

Reference Number: EMA/HMPC/384286/2006

Template for overview of comments received on on draft European Union herbal monograph or European Union list entry

AdoptedReference Number: EMEA/HMPC/411398/2006 Rev. 2

Inventory of herbal substances for assessment

AdoptedReference Number: EMA/HMPC/494079/2007

HMPC: overview of assessment work - priority list

AdoptedReference Number: EMA/HMPC/561868/2021

Reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries

AdoptedReference Number: EMEA/HMPC/326440/2007

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)

Reference Number: EMEA/HMPC/370642/2008

Standard operating procedure on establishment of Community herbal monographs, Community list entries and related documents

AdoptedLegal effective date: 27/09/2016Reference Number: SOP/H/3163