The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
Eudralex Volume 3 Investigation of Chiral Active Substances (3CC29A)
EMA
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Document Type:
Guideline
Content:
This guideline describes the data to be investigated and the type of information required for chiral active substances to be included in the dossier for a marketing authorisation application.