We can assist you with preparing and filing Drug Identification Number (DIN) applications and meeting the necessary requirements set out by Health Canada.
A Drug Identification Number (DIN) is a computer-generated 8-digit number, assigned to a drug product prior to being sold in Canada. Health Canada regulates drug products, including OTC drugs (Over-the-Counter medicines sold directly to consumers without a prescription) to ensure they are safe to use.
There are many monograph categories for OTC Drugs in Canada. They are Labeling Standard, TPD Category IV, and Non-steroidal Anti-Inflammatory Drugs (i.e. NSAIDs).
| Acetaminophen Labelling Standard | Acetylsalicylic Acid Labelling Standard | Anorectal Drug Products | Antacids | Anthelmintics | Antiflatulents |
|---|---|---|---|---|---|
| Antifungal (Naftifine & Imidazole) | Antifungals (topical) | Antitussive – Adult | Bismuth Subsalicylate | Cough and Cold | Paediatric Cough and Cold Products Attestation of Compliance |
| Cyproheptadine | Decongestant | Dimenhydrinate | Ethylene Oxide Gaseous Sterilants | Expectorant – Adult | Famotidine |
| Intravaginal (Miconazole & Clotrimazole) | Non-Classical Antihistamines | Poison Treatment | Sleep Aids | Topical Anaesthetic/Analgesic/Antipruritic | Topical Antibiotics |
NSAIDS Monograph ingredients include:
Obtaining a Drug Identification Number (DIN) is important because this number indicates the drug has met Health Canada’s requirements for safety, quality, and effectiveness.
A Drug Identification Number (DIN) is located on the label of prescription and OTC drugs and confirms that the product has been evaluated and authorized for sale in Canada.
To obtain a DIN for your drug products, 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 Drug Identification Number (DIN) is a computer-generated digit number, assigned to a drug product prior to being sold in Canada.
Health Canada regulates OTC (Over-the-counter medicines sold directly to consumers without a prescription) drugs to ensure they are safe to use and decrease the health risks for Canadians. In the USA, the FDA carries out a regulatory review of OTC drugs based on active pharmaceutical ingredients and labeling. More than 300,000 OTC drug products are available in the US market.
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