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New guidance document on administrative processing of submissions and applications

On December 11, 2017, Health Canada announced a guidance document clarifying the requirements for drug submissions and applications to be processed under the administrative pathway. The administrative pathway will be available, with some restrictions, in circumstances including: a manufacturer or product name change, additional product names, or licensing agreements between two manufacturers. “Any deviations from the previously approved product will not be acceptable under the administrative pathway.” This Guidance replaces the “Changes in Manufacturer’s Name and/or Product Name Policy” and is effective March 1, 2018. For application of the PMNOC Regulations, the Guidance refers to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations.