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
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Federal Court of Appeal restores Minister of Health’s decision to grant RUZURGI NOC despite FIRDAPSE data protection
The Federal Court found that subsection C.08.004.1(3) of the Food and Drug Regulations applied to prevent the Minister from issuing an NOC in view of the data protection granted to FIRDAPSE, a drug co...Read More -
Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices
On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing).Read More -
Certificate of Supplementary Protection filing fee increase effective April 1, 2023
On April 1, 2023, the fee for filing a Certificate of Supplementary Protection (CSP) will increase from $9,952 to $10,152 in accordance with subsection 9(1) of the Certificate of Supplementary Protect...Read More