Reminder of the Regulatory Requirements for DIN-issued Products
By: Sarah Calder, Regulatory Affairs Specialist, email
Recently, Health Canada released a guidance document to assist industry with the understanding of the regulatory requirements surrounding the issuance of a Drug Identification Number (DIN).
The focus of the document is to outline the obligation to accurately report to Health Canada the drug status and the changes to those statuses within the required timelines.
Once Health Canada issues a DIN or a DIN and Notice of Compliance (NOC), the manufacturer (licensee) receives a Drug Notification Form (DNF) and the Drug Product Database (DPD) updates to notify the public of its availability status. The status of a drug is listed as the manufacturer updates Health Canada of its status on the Canadian market. The status of a drug may be listed as:
- Cancelled Pre-market
- Cancelled Post-market
- Cancelled (Safety Issue), and
- Cancelled (Unreturned Annual)
Please see the guidance document for further information on these categories.
As required under the Food and Drug Regulations, manufacturers must update Health Canada when the status of a drug changes. Some examples of required notifications are:
- Market Notification – Health Canada requires a manufacturer to submit a notification of the drug going to market within 30 days of the first sale of that drug. This is accomplished by completing and submitting the issued Drug Notification Form. In some cases, the current market label must be submitted along with the DNF.
- 12 Months Without Sale Notification – A manufacturer is obligated under the Food and Drug Regulations to report the period of no sales to Health Canada after 12 months have elapsed without a sale of the drug. This notification should be made within 30 days.
- Discontinuation of sales notification – A manufacturer must notify Health Canada of the discontinuation of the sale of its drug within 30 days after the sale of that drug was discontinued.
Do you require assistance with carrying out your obligations with your DIN product status? Are you unsure how to inform Health Canada of your mandatory notifications?