What must be assigned to a drug before it can be sold in dosage form by a manufacturer?

Before a drug can be sold in dosage form by a manufacturer, it must be assigned a Drug Identification Number (DIN). The DIN is a unique number assigned by Health Canada that serves as an official identifier for prescription and over-the-counter medications sold in the Canadian market. This numbering system ensures that each drug is tracked and can be quickly referenced in records, facilitating effective monitoring of specific medications, including their safety and effectiveness.

Having a DIN indicates that the drug has undergone a rigorous assessment by regulatory authorities, ensuring compliance with safety, efficacy, and quality standards. It is a crucial part of the drug approval process, which verifies that the medication has been properly tested and meets all necessary regulatory requirements for sale.

While brand names and marketing authorizations are significant components in the pharmaceutical process, they are secondary to the assignment of a DIN. The brand name is chosen by the manufacturer for marketing purposes and does not hold regulatory weight while marketing authorization pertains to the legal permission to market the drug but cannot substitute for the mandatory DIN that identifies the specific formulation and dosage of the drug in Canada.