Drug Identification Number (DIN) Review – Canada
If you are selling a drug product in Canada you are most likely familiar with the term “DIN” which stands for Drug Identification Number. In order to sell a drug product in Canada and operate in compliance with Health Canada’s Food & Drug Regulations all companies must apply for and receive a DIN for their products.
A Drug Identification Number (DIN) is an eight-digit number assigned by Health Canada to a drug product prior to being marketed in Canada. The placement of the DIN on the package label provides evidence that the product has been evaluated and authorized for sale in Canada. Here are the elements specific to each DIN:
- name of manufacturer (company name selling product and responsible for product)
- product brand name
- active Ingredient
- strength of active ingredient
- form of product (such as capsule, stick)
- route of administration
Two sets of unique processes are involved for the DINs, getting a DIN and keeping a DIN. In order to receive a DIN for the product the complete drug application needs to be reviewed and approved by Health Canada. Review fees for the submission will depend on the type of application being submitted, with new chemical entity oriented applications commanding the highest fee, and over-the-counter products with a long and well-documented history of safe use requiring the minimal review fees.
Once the DIN’s are awarded, they must be maintained by following the DIN Annual Notification Process. During this process the overall master list of DIN’s will be sent to each manufacturer who is then responsible for confirming which DIN’s are currently being marketed in Canada. A yearly fee is then assigned for each DIN.
Failure to complete the annual notification form may result in DIN cancellation. Health Canada has provided some helpful information on the annual notification process in their latest notice now available at Health Canada’s website (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/ann-drug-med-notice-avis-eng.php). After reviewing the notice manufacturers will be able to understand the obligations of a drug product manufacturer in Canada, and avoid any unnecessary or premature cancellation of DINs for their products.
In circumstances involving mergers and buy-outs, an application for a new DIN may be required. The latest policy covering administrative changes such as a change in manufacturers name or change in product name should be read in conjunction with intended changes to ownership of drug products. http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/admin-proc-draft-gd-ebauche-ld-trait-eng.php.
