Transcription of Guideline on the use of the CTD format in the ... - Europa
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Guideline on the use of the CTD format in the ... - Europa
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 5 April 2016 EMA/HMPC/71049/2007 Rev. 2 Committee on herbal Medicinal Products (HMPC) Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products1 Final - revision 2 Draft agreed by Organisational Matters Drafting Group (ORGAM DG) April 2007 Adoption by HMPC for release for consultation 8 May 2007 End of consultation 15 August 2007 Agreed by ORGAM DG 3 October 2007 Adoption by HMPC 10 January 2008 Date for coming into effect 10 January 2008 Draft revision 1 agreed by Quality Drafting Group (Q DG) April 2012 Draft revision 1 adopted by HMPC for release for consultation 22 May 2012 End of consultation 15 October 2012 Revision 1 agreed by Q DG December 2012 Revision 1 agreed by ORGAM DG February 2013 Adoption revision 1 by HMPC 12 March 2013 Draft revision 2 agreed by ORGAM DG September 2014 Draft revision 2 agreed by Monograph and List Working Party (MLWP)
Dossier for traditional use registration of traditional herbal medicinal products The table below describes the CTD structure and provides additional guidance to that included in the Volume 2B of the Notice to Applicants (Presentation and format of the dossier C TD).
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