eCTD submission

Health Canada moving towards electronic submissions for DMF’s.

Health Canada is moving towards accepting all new DMFs only in non-eCTD electronic formats or eCTD formats effective immediately. For existing DMFs some conditions apply.

As of January 1, 2016, Health Canada will no longer accept paper copies of DMF transactions. Any paper received after this date will be shredded or returned at the owner”s expense.

By March 31, 2016, all existing DMFs in paper format must be replaced by a complete DMF conversion in “non-eCTD electronic-only” format. Failure to provide the complete electronic copy of the DMF will result in the DMF being suspended (no further access for review will be granted and no update will be accepted for the DMF).

More details available at:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_dmf_prep_fmm_avis_non_ectd-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/gd_prep_non_ectd_ld-eng.php#a13

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KnetAdmin

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