Notice - Intellectual Property Hold for Notifiable Change Submissions

April 7, 2017
Our file number: 17-104009-682

This notice applies to subsequent entry manufacturers under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) and the data protection provisions at section C.08.004.1 of the Food and Drug Regulations.

When the review of a notifiable change submission is complete and the related submission is on Intellectual Property (IP) Hold due to the PM(NOC) Regulations or section C.08.004.1 of the Food and Drug Regulations, the notifiable change submission is also placed on IP Hold. At this time, the Office of Submissions and Intellectual Property (OSIP) sends a letter to notify sponsors that the notifiable change submission has been placed on IP Hold.

OSIP will be eliminating IP Hold letters for notifiable change submissions as of May 1, 2017. Sponsors are encouraged to view the status of their notifiable change submissions in the Drug Submission Tracking System - Industry Access (DSTS-IA). The status of the notifiable change submission in the DSTS-IA will be updated to “IP Hold” to notify sponsors when the review of the submission is complete.

Questions related to this Notice should be directed to the Office of Patented Medicines and Liaison at opml_bmbl@hc-sc.gc.ca.