Nexreg can work with your company to develop drug product labels which meet Canadian requirements. As well, Nexreg's team of experts will complete the DIN Submission Certification form required by the Therapeutic Products Directorate (TPD) of Health Canada. The Drug Identification Number (DIN) is the number located on the label of prescription and over-the-counter drug products approved for sale in Canada.
When is a DIN required?
A DIN is required for all approved prescription and over-the-counter drugs in Canada; that is any product defined as a drug under the Food and Drugs Act. This includes medicinal herbs or herbs marketed with drug claims. The food and drug act defines a drug as including:
“any substance or mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying organic functions in human beings or animals, or (c) disinfection in premises in which food is manufactured, prepared or kept”
If your company’s product falls under this definition, it will require a Drug Identification Number (DIN) submission.