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Guideline

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.

Guideline on Active Substance Master File Procedure (CPMP/QWP/ 227/02 Rev. 2)
Short Title:CPMP/QWP/ 227/02 Rev. 2
Internet:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002811.pdf
Origin/Publisher:EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Content:This Guideline is intended to assist applicants in the compilation of the active substance section of their dossiers for a marketing authorisation application.
Status:Draft
Document Type:Guideline