

Drug OTC Product Licensing
Drug OTC Product Licensing


We can handle your DIN- labelling standard and Category IV Monograph DIN applications. These are determined by the amount and ingredients in your product. When the dose is higher than an NHPD Monograph- the product may fall into this category which requires a modified DIN application for product license approval. The application still follows the eCTD format. Though it is modified and shortened to accommodate for the lower-risk ingredients in the following product categories.
The Category IV Monographs include:
• Acne Therapy | • Sunscreen Monograph | • Medicated Skin Care Products |
• Diaper Rash Products | • Anti-Dandruff Products | • Antiseptic Skin Cleansers |
• Athletes Foot Treatment | •Throat lozenges | • Disinfectants |
The Category IV Monographs include:
• Acne Therapy | • Sunscreen Monograph | • Medicated Skin Care Products |
• Diaper Rash Products | • Anti-Dandruff Products | • Antiseptic Skin Cleansers |
• Athletes Foot Treatment | •Throat lozenges | • Disinfectants |
Drug OTC FAQ
- You require a Drug Identification Number (DIN) which is an 8-digit designation.
- An Establishment License for the facility the product is being manufactured in.
- A Canadian compliant bilingual label, with Canadian Drugs Facts Table.
Depending on the type of application the Health Canada fee varies (Few examples):
- New Pharmaceutical DIN with Clinical or non-clinical data and chemistry and manufacturing data – $224,242.00.
- DIN submissions based on comparative studies - $55,737.00.
- Full Disinfectants Review - $7,126.00
- Category IV / Labelling Standards DIN application - $1,613.00
Timeline varies depending on the type of DIN application. Full list of Health Canada’s DIN performance standards can be found here.
- If your facility fabricates, packages, labels, distributes, imports, wholesales, or tests a drug you must apply to receive a Drug Establishment Licence (DEL).
- Hard Surface disinfectants do not need an Establishment licence.
The Health Canada fee depends on the activity and can range from as low as $2,560.00 CAD (Testing facility) to $41,626.00 CAD (Fabrications) and is subject to change every fiscal year.