1. What are over-the-counter drug products (OTC drugs)?
Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can be bought without a doctor’s prescription. OTC drugs can include things like hand sanitizer, sunscreens, cold & flu medication, and medicated topical products such as skin treatments, lip ointment, and anti-fungal creams.
2. What licensing is required for OTC drugs?
Non-prescription drugs require a valid Drug Identification Number (DIN) to be sold in Canada. On a product label, this number indicates the drug has met our requirements for safety, quality, and effectiveness.
Furthermore, Canadian companies that manufacture, package, label, and import OTC drugs must:
- Be licensed for these activities (i.e. hold a Drug Establishment License aka DEL)
- Provide the necessary documents and evidence
A DEL is provided after a satisfactory inspection.
3. What is a DIN and how does it apply to OTC drugs?
A Drug Identification Number (DIN) is an eight-digit number that is assigned by Health Canada to OTC drugs prior to them being marketed in Canada. The DIN is a unique number that identifies all drug products sold in a dosage form in Canada. The DIN is located on the label of prescription and OTC drugs that have been evaluated and authorized for sale in Canada.
4. Can a product classified as an OTC drug be sold without a DIN?
If a product defined as a drug under the Food and Drugs Act is sold without a DIN, it is not in compliance with Canadian law, and regulatory action will be taken.
5. How do I obtain a DIN for my OTC drugs?
To obtain a DIN for your OTC drugs, a DIN submission must be filed with Health Canada. Prior to issuing DINs, Health Canada’s Drugs Directorate requires the submission of sufficient data to evaluate the safety and efficacy of a drug for its intended use. A submission for a DIN should contain the following information for review:
- a completed Drug Submission Application, including proposed Canadian labels and prescribing information or a package insert where applicable
- a completed DIN Submission Certification or Category IV Drug Submission Certification as appropriate
- specific product type information as requested by Health Canada
6. How long does it take to get a DIN for my OTC drugs?
Health Canada offers the following service standards for DIN submissions:
- DIN-A – Drug Identification Number Application (Labelling Only) – 180 days
- DIN-A – Drug Identification Number Application (Labelling Standard) – 45 days
- DIN-D – Disinfectant Drug Identification Number Application (Non-Clinical/Clinical Only) – 210 days
- DIN-D – Disinfectant Drug Identification Number Application (Labelling Only) – 180 days
- DIN-D – Disinfectant Drug Identification Number Application (Labelling Standard) – 45 days
- DIN-F – Category IV Monograph Drug Identification Number Application (Labelling Standard) – 45 days