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Can I read Electronic Submission Guidelines for MRP on EtoBox?
Electronic Submission Guidelines for MRP is a document available to read on EtoBox.
What is Electronic Submission Guidelines for MRP about?
The document provides requirements for electronic submissions for new marketing authorization applications within the Mutual Recognition Procedure, Decentralized Procedure, and national procedures. It outlines that electronic submissions are recommended in eCTD format but the Non-eCTD format is also accepted. A table is included that lists the number of electronic copies required by each national competent authority, noting some authorities still require some paper modules as well. Guidance is provided on a
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