Summary on Recent Intellectual Property Hold for Notifiable Change SubmissionsPublished on August 7, 2017
Author: Pinky Mazumder
On April 7th, 2017, Health Canada released the Intellectual Property Hold for Notifiable Change Submissions notice. This notice is geared towards subsequent entry manufacturers and sponsors as per the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations.
When filing submissions for subsequent entry products, the subsequent manufacturer and/or sponsor includes the patent of the innovative product from the Patents Register. If the subsequent entry product submission is placed on an Intellectual Property (IP) Hold, any notifiable changes related to that submission will also be placed on an IP Hold upon completion of the notifiable change review. Previously, when notifiable change submissions were placed on an IP Hold, the Office of Submission and Intellectual Property (OSIP) of Health Canada, would notify sponsors with a letter indicating that their notifiable change has been placed on an IP hold.
However according to the notice, as of May 1st, 2017, OSIP is no longer sending out IP Hold letters for notifiable changes. The notice also aims to inform subsequent entry manufacturers and sponsors that while they will no longer receive IP Hold letters for notifiable change submissions, they should check the status of their submissions in the Drug Submission Tracking System - Industry Access. If the notifiable change in placed on an IP Hold, the status of the submission will state “IP Hold” to notify sponsors when the review is complete. For more information on the notice on Intellectual Property Hold for Notifiable Change Submissions, please refer to: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/ip-nc-hold-notice-avis-pm-pi-suspens-eng.php. For more information on subsequent entry manufacturers, please refer to the Patented Medicines (Notice of Compliance) Regulations from Health Canada.
Thank you for reading Regulated Affairs, the CAPRA blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.
Technology Continues to Transform Healthcare and the Regulatory World
Introduction: Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of individuals shifts more...
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...
Health Canada changes filing requirements for product monographs
Did you know, effective immediately, Health Canada is changing the submission requirements for second language product monographs for human drugs? This is for only post-life...