Notice: Publication of Update to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations

May 17, 2017
Our file number: 17-105376-499

Health Canada is pleased to announce the publication of an update to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations.

The Office of Patented Medicines and Liaison (OPML) within the Office of Submissions and Intellectual Property, Therapeutic Products Directorate (TPD), administers the data protection provisions under section C.08.004.1 of the Food and Drug Regulations on behalf of Health Canada. All drug submissions seeking a Notice of Compliance, including those submitted to the TPD, the Biologic and Genetic Therapies Directorate, the Natural and Non-prescription Health Products Directorate and the Veterinary Drugs Directorate, are assessed to determine if they fall within the scope of section C.08.004.1 of the Food and Drug Regulations.

This Guidance Document was originally adopted on March 11, 2009 and there were minor updates made in 2010 and 2011. Since the last update to the Guidance Document, there have been a number of judicial considerations of the data protection provisions with respect to the determination of “innovative drug”. This update is being made to clarify the administration of the data protection provisions following the jurisprudence, and as such there are no policy changes being made. The updates will also reflect current administrative practices regarding the maintenance of the Register of Innovative Drugs, the application of the six-month pediatric extension and provides direction regarding how to submit information and correspondence relating to data protection in the current electronic environment.

Questions or concerns related to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations should be directed to the Office of Patented Medicines and Liaison at: