When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and must be printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its regulations, and the drug has a favourable risk/benefit profile. Manufacturers of prescription and non-prescription drugs must obtain a DIN before they are marketed in Canada. The DIN assigned to a drug is unique and serves as a tool to help in the post-market activities of products on the market, such as product identification and verification by health care professionals, recall of products, inspections, and quality monitoring. While the authorization of a drug includes the issuance of a DIN to the manufacturer, the DIN is the property of Health Canada.
DIN issuance by Health Canada to the manufacturer
Once a drug has been authorized for sale in Canada, Health Canada issues a DIN under Part C, Division 1 of the Food and Drug Regulations, which permits the manufacturer to market the drug in Canada. For drugs that meet the definition of a new drug under Part C, Division 8 of the Food and Drug Regulations, the drug is required to have a Notice of Compliance (NOC) in addition to a DIN, in order to be authorized for sale in Canada. The DIN is issued in the form of a Drug Notification Form (DNF). The DNF contains, in addition to the DIN, information that is specific to the drug as it has been authorized by Health Canada. DNFs are sent by email directly to the manufacturer by Health Canada. For manufacturers seeking authorization under Part C, Division 1 of the Food and Drug Regulations for drugs for human or veterinary use, no NOC is granted. Instead, the DIN, in the form of a DNF, represents the market authorization.
Issuance of a revised Drug Notification Form by Health Canada to the manufacturer
Any change that the manufacturer wants to make to one or more of the drug characteristics (i.e. Product name, manufacturer name, active ingredients, strength of active ingredients, dosage forms, route of administration) must be authorized by Health Canada before the DNF can be revised. A submission or application seeking authorization for the proposed changes must be filed. Changes to an authorized label to include or modify retail-specific branding elements (e.g., graphics, colour, and font, etc.) also may require a review and authorization by Health Canada before they can be introduced on the market. After the change is approved by Health Canada, a revised DNF with the same DIN or a new DIN may be issued to the manufacturer.
Filing of market notifications by the manufacturer to Health Canada
As per section C.01.014.3 of the Food and Drug Regulations, the manufacturer has the obligation to notify Health Canada when it first sells a drug that has been issued a DIN. A manufacturer must submit a completed DNF to Health Canada within 30 days of first selling the drug. The DNF must be filled out, signed, and dated. All pages of the DNF must be returned to Health Canada. If a manufacturer has been issued a revised DNF, it must notify Health Canada when it begins to market the drug with the authorized change within 30 day of selling the drug with new changes.
A market notification consists of:
- A cover letter
- A completed and signed DNF
- Labelling material, when applicable
Filing of 12 months without sale notifications by the manufacturer to Health Canada
After a drug has been marketed, a manufacturer is obligated under the Food and Drug Regulations to report when 12 months have elapsed without a sale of its drug to Health Canada when the following conditions are met:
- the drug has received an NOC and/or a DIN
- the drug has been marketed; and
- the drug has not been sold on the Canadian market for a period of 12 consecutive months
Manufacturers of all drugs are encouraged to report 12 months without sale within 30 days as this will allow Health Canada as well as patients, health care practitioners, and other health care stakeholders to have a clear and up to date picture of which drugs are available on the Canadian market. However, manufacturers of prescription drugs for human use must submit a notification to Health Canada within 30 calendar days after a period of 12 consecutive months without sale.
After a complete notification is received and processed, Health Canada updates the status of the drug in the Drug Product Database to “Dormant”. A drug that is deemed Dormant is still authorized for sale in Canada.
Filing of discontinuation of sale notifications by the manufacturer to Health Canada
The manufacturer must submit the notification of discontinuation of sale within 30 days after the sale of the drug was discontinued as per section C.01.014.7 of the Food and Drug Regulations. The date of discontinuation is when the manufacturer last sells its drug, not when it is last sold at retail. Health Canada cancels the DIN further to the receipt of the notification.
The notification of discontinuation of sale from the manufacturer should be in writing on company letterhead and should provide the lot number and the expiry date of the last lot distributed in Canada, the discontinuation date, and signed by an authorized official.
If you want to be sure your products are in compliance with Canadian regulatory requirements associated with a DIN, Quality Smart Solutions has a team of specialists who can assist you. Get prepared now and contact us today to discuss how we can be your solution!
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Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs), June 19, 2019, Health Canada, https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-requirements-drug-identification-numbers/document.html