Drug Identification Number (DIN) Registration

We can assist you with preparing and filing Drug Identification Number (DIN) applications and meeting the necessary requirements set out by Health Canada.

Drug Identification Number (DIN)

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.

Drug Identification Number DIN

Monograph Categories for Over-the-Counter Drugs

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).

Labelling Standards Non-prescription Monographs are:

Acetaminophen Labelling StandardAcetylsalicylic Acid Labelling StandardAnorectal Drug ProductsAntacidsAnthelminticsAntiflatulents
Antifungal (Naftifine & Imidazole) Antifungals (topical) Antitussive – AdultBismuth SubsalicylateCough and ColdPaediatric Cough and Cold Products Attestation of Compliance
CyproheptadineDecongestantDimenhydrinateEthylene Oxide Gaseous Sterilants Expectorant – Adult Famotidine
Intravaginal (Miconazole & Clotrimazole)Non-Classical Antihistamines Poison Treatment Sleep Aids Topical Anaesthetic/Analgesic/AntipruriticTopical Antibiotics

Category IV Monographs Include

Acne Therapy
Sunscreen Monographs
Medicated Skin Care Products
Diaper Rash Products
Anti-Dandruff Products
Antiseptic Skin Cleansers
Athlete’s Foot Treatments
Throat Lozenges
Note that these Category IV Monographs are also listed as NHP Monographs. Some of the ingredients in these monographs are classified as NHPs, while others are classified as drugs.

NSAIDS Monograph ingredients include:

  • Celecoxib
  • Diclofenac
  • Ibuprofen
  • Indomethacin
  • Meloxicam
  • Naproxen

Manufacturing of DIN Products

  • DIN products must be manufactured in a facility that follows good manufacturing practices (GMP)
  • If the facility is based in Canada, that business must obtain a drug establishment license
  • Foreign sites must also show evidence that they are following GMP through a Health Canada licensed importer
  • DIN products cannot be sold prior to license issuance
  • Licensing timelines vary and can be as fast as 45 days 
  • Health Canada’s fees for drug license application submissions are due initially upon submission of an application and annually thereafter
  • The fee varies and increases annually based on the rate of inflation
DIN Drug Identification Number

Frequently Asked Questions - Drug Identification Number

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 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

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.

  • DIN products must be manufactured in a facility that follows good manufacturing practices (GMP)
  • If the facility is based in Canada, that business must obtain a drug establishment license
  • Foreign sites must also show evidence that they are following GMP through a Health Canada licensed importer
  • DIN products cannot be sold prior to license issuance
  • Licensing timelines vary as fast as 45 days 
  • Health Canada’s fees for drug license application submissions are due initially and annually thereafter
  • The fee varies and increases annually based on the rate of inflation
  • Celecoxib
  • Diclofenac
  • Ibuprofen
  • Indomethacin
  • Meloxicam
  • Naproxen
  • Labeling Standard
  • TPD Category IV
  • Non-steroidal Anti-Inflammatory Drugs (NSAIDS)
  • Acne Therapy
  • Sunscreen Monographs
  • Medicated Skin Care Products
  • Diaper Rash Products
  • Anti-Dandruff Products
  • Antiseptic Skin Cleansers
  • Athlete’s Foot Treatments
  • Throat Lozenges

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