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.

Change Control Process for European eSubmission Standards - v2.1 (May 2011)


European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium),

This document establishes the change control process for European eCTD standards in the EEA.

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