There are several monograph categories for Over-the-Counter (OTC) Drugs in Canada. These include Labeling Standard, TPD Category IV, and Non-steroidal Anti-Inflammatory Drugs (i.e. NSAIDs).
Labelling Standards Non-prescription Monographs include:
- Acetaminophen Labelling Standard
- Acetylsalicylic Acid Labelling Standard
- Anorectal Drug Products
- Antifungal (Naftifine & Imidazole)
- Antifungals (topical)
- Antitussive – Adult
- Bismuth Subsalicylate
- Cough and Cold
- Paediatric Cough and Cold Products Attestation of Compliance
- Ethylene Oxide Gaseous Sterilants
- Expectorant – Adult
- Intravaginal (Miconazole & Clotrimazole)
- Laxatives: Bulk Forming, General, Kit Bowel Cleansing System, Lactulose, Lubricant, Stimulant, Stool Softener
- Non-Classical Antihistamines
- Poison Treatment
- Sleep Aids
- Topical Anaesthetic/Analgesic/Antipruritic
- Topical Antibiotics
- Topical Nasal Decongestants
- Triethanolamine Salicylate
Category IV Mongraphs Include:
- Acne Therapy
- Sunscreen Monographs
- Medicated Skin Care Products
- Diaper Rash Products
- Anti-Dandruff Products
- Anti-septic Skin Cleansers
- Athlete’s Foot Treatments
- Throat Lozenges
Note that these Category IV Monographs are also listed as NHP Mongraphs. Some of the ingredients in these monographs are classified as NHPs, while others are classified as drugs.
NSAIDS Monograph ingredients include:
A Drug Identification Number (DIN) is a computer-generated eight digit number assigned by Health Canada to a drug product prior to being marketed in Canada.
Effective June 15, 2017, DIN applications must now include a ready-to -print label that follows the new Plain Language Labelling regulations.
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 with as fast as 45 days. During the COVID-19 pandemic, some OTC drug licences such as disinfectants, may be issued in as fast as 2 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.