Notice: Publication of Update to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations

May 11, 2018
Our file Number: 18-104750-127

Health Canada is pleased to announce the publication of an update to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations.

The Office of Patented Medicines and Liaison (OPML) within the Office of Submissions and Intellectual Property, Therapeutic Products Directorate (TPD), administers the Patented Medicines (Notice of Compliance) Regulations on behalf of Health Canada. All drug submissions seeking a notice of compliance, including those submitted to the TPD, the Biologics and Genetic Therapies Directorate, the Natural and Non-prescription Health Products Directorate and the Veterinary Drugs Directorate, are assessed to determine if the Patented Medicines (Notice of Compliance) Regulations apply.

Amendments to the Patented Medicines (Notice of Compliance) Regulations came into force on September 21, 2017. The Guidance Document has been updated in accordance with the amendments. The updates also reflect current administrative practices, for example the update of terminology from “patent hold” to “intellectual property hold”, and direction on the submission of information and correspondence in the current electronic environment.

Questions or concerns related to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations should be directed to the Office of Patented Medicines and Liaison at hc.opml-bmbl.sc@canada.ca.