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
Related Publications & Articles
-
Medical Devices updates: Phase II consultation on Medical Devices Regulations amendments, medical device licences guidance and IMDRF table of contents guidance
On November 17, 2025, Health Canada proposed Phase II amendments to the Medical Devices Regulations (MDR). The first phase of amendments came into force on December 14, 2024 and relate to recalls, mod...Read More -
Proposal for modernizing clinical trial framework aims to improve access to new and innovative therapies in Canada
On December 20, 2025, Health Canada launched a consultation on modernizing the framework for clinical trials involving drugs for human use, including pharmaceuticals, biologics, radiopharmaceuticals, ...Read More -
Health Canada consultation on two draft guidance documents on terms and conditions for human and veterinary drugs and drug submissions based on promising evidence of clinical efficacy
As previously reported, in December 2024, Health Canada published its agile licensing amendments to the Food and Drug Regulations.Read More
