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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.

Guidance on paper submission with eCTD version 1.0 (February 2006)
Internet:http://ec.europa.eu/health/files/eudralex/vol-2/b/ectd_01-20006/ectdpaperv1.0.pdf
Origin/Publisher:European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Content:This guidance makes recommendations regarding the presentation of the paper submission that is provided by the applicant when an eCTD submission is also provided