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Canada Sets Deadline for Electronic Filing-Only of DMFs

November 25, 2015

Health Canada announced that by March 31, 2016, all existing Drug Master Files (DMFs) in paper format must be replaced by electronic copies. In a Guidance Document: Preparation of Drug Regulatory Activities in "Non-eCTD Electronic-Only" Format, published September 25, the Agency cautioned that, "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)."

The Guidance also stated that all new DMFs; transactions related to existing DMFs, such as letters of access and administrative information; and DMF updates should be submitted in "non-eCTD electronic-only" format effective immediately. Accordingly, the first DMF update after September 25, must also include a complete DMF conversion in "non-eCTD electronic-only" format for the existing DMF in paper format. Paper copies of Drug Identification Number (DIN) applications and DMF transaction will not be accepted after January 1, 2016.