Drug OTC Product Licensing in Canada

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

What do I need to sell a Drug OTC in Canada?

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.

What is the cost to apply for a DIN?

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?

Timeline varies depending on the type of DIN application. Full list of Health Canada’s DIN performance standards can be found here.

Who needs an Establishment Licence?

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.

What is the cost of 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.

Solutions