The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
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Guideline on Active Substance Master File Procedure (CPMP/QWP/227/02 Rev. 1)
EMA
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Document Type:
Guideline
Content:
This Guideline is intended to assist applicants in the compilation of the active substance section of their dossiers for a marketing authorisation application.