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Appendix 1 Best Archiving Practice Specifications, version 1.0, June 2013

This Appendix to the Best Archiving Practice defines detailed specifications for archiving of eSubmissions. It contains a description of a recommended digital archival information system, archival information packages and the content of these packages. Content description consists of guidelines for files and fonts. Archival information package and content specification are recommended to be applied by all agencies. The solution to implement an archival information system varies by agency but the main principles described here should be applicable in most cases. This Appendix can be updated separately from the Best Archival Practice document as file format versions and other such details will change over time.

best archiving practice; eCTD; font embedding

This document has been published under the auspices of the EU Telematics Implementation Group - electronic submissions (TIGes)