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.
Looking for assistance with securing DIN numbers for your OTC drugs?
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
How Quality Smart Solutions can help
Our Experts at Quality Smart Solutions are here to help and offer any drug-related regulatory advice and support on successfully securing your DIN, responding to potential information requests, keeping your license updated, and reviewing your drug labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here:
