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.
Related Publications & Articles
-
Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision
On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data...Read More -
CIPO will not issue patents on July 9 or July 16
The Canadian Intellectual Property Office (CIPO) will be launching a new online portal for patent services, MyCIPO Patents, on July 15, 2024.Read More -
2024 mid-year highlights in Canadian life sciences IP and regulatory law
In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories ...Read More