Canada’s Intellectual Property Firm

Release of Guidance Document: Regulatory requirements for Drug Identification Numbers

Authored byUrszula Wojtyra

On May 3, 2019, Health Canada released the new Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs). The Guidance Document is stated to provide “assistance on the interpretation of the regulatory requirements associated with a DIN” and “guidance to manufacturers on their obligation to accurately report to Health Canada [certain] notifications for a change of drug status.” This Guidance Document replaces a number of Health Canada documents including:

  • Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of Discontinuation of Sales
  • Issuance of Drug Identification Numbers for New Drugs