Drug Identification Number Registration

What is a 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.

It uniquely identifies all drug products sold in a dosage form in Canada and is located on the label of prescription and over-the-counter drug products that have been evaluated and authorized for sale in Canada. It is very important as this allows pharmacies to dispense the correct drug and helps ensure safe patient care.

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 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

Who needs to register their DIN?

Anyone who wishes to sell their product as an NHP or as a drug in Canada must have their DIN registered with Health Canada. A Drug Identification Number (DIN) is a unique identifier for health products and devices, including drugs, biologics and medical devices. The DIN numbers are assigned by Health Canada after a review of the product’s chemistry, manufacturing methods, quality assurance systems and packaging material used. If you want to market your product in Canada as either an NHP or as a drug, you will need one or both of these numbers.

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

Frequently Asked Questions - Drug Identification Number

Why is DIN registration important?

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.

What is the purpose of DIN?

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.

How can I get a DIN number?

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

What is a DIN number?

A Drug Identification Number (DIN) is a computer-generated digit number, assigned to a drug product prior to being sold in Canada.

Who regulates over-the-counter drugs?

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.

How are DIN products manufactured?

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

What are Nonsteroidal Anti-inflammatory Drugs (NSAID) Monograph ingredients for OTC Drugs?

What are the monograph categories for OTC Drugs in Canada?

Labeling Standard
TPD Category IV
Non-steroidal Anti-Inflammatory Drugs (NSAIDS)

What do category IV monographs include?

Drug Identification Number (DIN) Registration