Drug Identification Number Registration

Drug Identification Number (DIN) Registration

Avail our assistance for reviewing drug application requirements and preparing your application to apply for Drug Identification Number (DIN) Registration followed by receiving a DIN from Health Canada.

About Drug Identification Number (DIN)

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 health risks of Canadians. In USA, FDA carries out a regulatory review of OTC drugs based on active pharmaceutical ingredients and labelling. More than 300,000 OTC drug products are available in the US market.

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

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 an establishment licence.
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 licence application submissions are due initially and annually thereafter.
The fee varies and increases annually based on the rate of inflation.

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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