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 Guideline on Active Substance Master File Procedure

Short Title:
CHMP/QWP/227/02 Rev 4; EMEA/CVMP/134/02 Rev 4

EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Document Type:
This Guideline is intended to assist applicants in the compilation of the active substance section of their dossiers for a marketing authorisation application.

Go back

GMP Conferences by Topics