Common Technical Document

A request for a registration or marketing authorisation of an herbal medicinal product for human use must be submitted in CTD format. This is described in appendix I of the royal decree dated 14/12/2006 concerning medicines for human and veterinary use and in the appendix of European directive 2001/83/EC  (Eudralex).

The CTD format includes 5 modules that are identical for all member states of the European Union. The exact structure is described in part 2B of the Eudralex collection published by the European Commission (Eudralex).

In that volume you can find references to the European and international guidelines concerning the scientific contents of a file and a "Questions & Answers document " about the practical use of this format in the European Union.
Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products”

Other information (monographs, list of traditional medicines) and specific guidelines can also be found on the EMEA website under the “Herbal Medicinal Products” section.

Modules 2 to 5 are identical for the European Union, the United States and Japan. More detailed information is available on the ICH website (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use).















Last updated on 16/12/2020