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, for:

  • manufacturer or product name change applications;
  • additional product name applications; and
  • licensing agreements between two manufacturers.

Any deviations from a previously approved product will be unacceptable under the administrative pathway.

This guidance replaces the Changes in Manufacturer's Name and/or Product Name Policy and will be effective from March 1 2018. For application of the Patented Medicines (Notice of Compliance) Regulations, the guidance refers to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations.

For further information on this topic please contact Brandon Heard at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (brheard@smart-biggar.ca). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.

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