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OTC Drug Identification Number License (DIN)

Quality Smart Solutions prepares DIN submissions for over-the-counter (OTC) products that follow Health Canada published monographs: Labeling Standard, Category IV, or Non-steroidal Anti-Inflammatory Drugs (i.e. NSAIDs).

A Drug Identification Number (DIN) is a computer-generated eight-digit number assigned by Health Canada to a drug product prior to being marketed in Canada. It exceptionally distinguishes all drug items sold in a dosage structure in Canada and is situated on the label of the products and over-the-counter medication items that have been assessed and approved to be sold in Canada.

A Drug Identification Number distinguishes the accompanying item qualities: producer; item name; dynamic ingredient(s); strength(s) of dynamic ingredient(s); pharmaceutical structure; course of the organization.

When a product has been approved, Health Canada gives a DIN which allows the producer to advertise the medication in Canada. For drugs where there is insignificant market history in Canada, there is a progressively tough survey and the medication is required to have a Notice of Compliance (NOC) and a Drug Identification Number so as to be advertised in Canada.

A DIN tells the consumer that the item has experienced and passed an audit of its definition, marking, and directions for use. A medication item sold in Canada without a DIN isn’t in conformation with Canadian law.

The Drug Identification Number is one of a kind and fills in as an instrument to help in the follow-up of items available, review of items, examinations, and quality checking.

DIN products cannot be sold prior to license issuance. In addition, Health Canada has a fee structure associated with DIN submissions. Whether you have a national brand or a private label drug that you are planning to launch in Canada, we are your solution to DIN submission filings for non-prescription drugs.

 

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