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

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

Keywords: Herbal medicinal products (HMPs) ; traditional herbal medicinal products (THMPs); CTD; traditional use simplified registration; HMPC

Current effective version

Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products- Revision 2

Adopted Reference Number: EMA/HMPC/71049/2007

Document history - Revision 2

Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products- Revision 2

Adopted Reference Number: EMA/HMPC/71049/2007

Overview of comments received on guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products-Revision 2

Adopted Reference Number: EMA/HMPC/669906/2015

Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 2

Draft: consultation closed Consultation dates: 09/04/2015 to 15/07/2015 Reference Number: EMA/HMPC/71049/2007 Rev. 2 Summary:

This document aims to provide guidance on how to present the application for registration of traditional herbal medicinal products (THMPs) in the Common Technical Document (CTD) format, providing information to help applicants in their submissions. Revision 2 pertains to the presentation and content of Modules 2, 4 and 5 of dossiers for THMPs. More detailed clarifications have therefore been introduced mainly in sections 1.5, 2.4, 2.5, 5.3 and 5.4.

For further guidance on the content of Module 3 on Quality a mock-up has been included as Appendix 2. It serves as an example but does not necessarily represent all quality requirements.

Concept paper on the need to update the note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders and the note for guidance on the clinical investigation on hypertension - Revision 4

Reference Number: EMEA/CHMP/EWP/350495/2009

Document history - Revision 1

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

Adopted Reference Number: EMA/HMPC/71049/2007 Rev. 1

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

Reference Number: EMA/HMPC/768094/2012

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

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

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.

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

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

Document history - First version

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

Adopted Reference Number: EMEA/HMPC/71049/2007 Legal effective date: 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

Reference Number: EMEA/HMPC/539645/2007