Bringing a drug or a natural health product to market in Canada involves applying for an 8-digit numerical code, called a DIN for drugs, or an NPN for natural health products. Beyond the fact that a DIN and an NPN are both 8-digit numerical codes, they both have different regulatory requirements, which we will help you decipher in this blog.
DIN, which stands for Drug Identification Number, is a computer-generated 8-digit numerical code assigned by Health Canada to a drug product (prescription and over-the-counter drugs) prior to being marketed in Canada. The DIN Number is a unique number and identifies the drug’s characteristics such as the manufacturer, product name, active ingredient(s), strength(s) of active ingredient(s), pharmaceutical form, and route of administration.
The issuance of a DIN permits the manufacturer to market the drug in Canada. It also indicates that the product has undergone and passed a review of its formulation, labelling, and instructions for use. A drug product sold in Canada without a DIN is not in compliance with the law.
NPN, which stands for Natural Product Number, is an eight-digit numerical code assigned to each Natural Health Product approved to be marketed under the Natural Health Products Regulations. Similar to the requirements for drugs. All natural health products are required by the Natural and NPN-prescription Health Products Directorate (NNHPD) to submit a Product Licence Application (PLA) prior to being marketed in Canada. The PLAs will be screened against regulatory requirements as outlined in the regulations and guidance documents for safety and efficacy, a Product Licence will be issued for applications satisfying the regulatory requirements. The Product Licence will include the NPN assigned to the product. In Canada, no person shall sell a natural health product unless a product licence is issued to the natural health product.
As per the Food and Drugs Act(Act), a drug is defined as a product that is offered for sale in Canada to treat or prevent diseases or symptoms.
Natural Health Products are defined as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (like Traditional Chinese Medicines), probiotics, and other products like amino acids and essential fatty acids. Under the Natural Health Product Regulations, a natural health product must be safe and used as an over-the-counter product. Natural health products are available for self-care and self-selection, and do not require a prescription to be sold.
Generally speaking, any ingredients that are not classified as a Natural Health Product under Schedule 1 of the Natural Health Products Regulations, would be considered drug ingredients and should proceed with a drug application. However, exceptions apply.
If you would like to learn more about the differences between DINs and NPNs, or would like to find out how your product is classified, contact us today.