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05.08.2015

Updating of the HMPC-Guideline on the use of the CTD Format in the Registration of Traditional Herbal Medicinal Products

Recommendation

6/7 October 2026

Drug Master File Procedures in the EU, the US and Japan - Live Online Training

Compared to herbal medicinal products (HMPs) there is a simplified registration procedure for traditional herbal medicinal products (THMP).

EMA's HMPC (Committee on Herbal Medicinal Products) published the draft of revision 2 on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products on 10 March 2015.

This guideline contains instructions on how to prepare a CTD for a registration application of traditional herbal medicinal products.

Now, there is a new annex 2 with a mock-up which shows by means of a concrete example where and to what extent information should be given on traditional herbal medicinal products in the dossier.

Appendix 1 is a best practice guide for module 3 on quality.

For further information please see the complete draft revision 2 of the "Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products" comprising more than 151 pages together with all annexes (!).