Whether you are selling your own product or a company’s, getting your license for selling drugs in Canada can be challenging. However, if possible, the Canadian government offers many solutions to get licensed relatively easily. The goal of this blog post is to help you understand more about different ways to license OTC Products in Canada and the steps that are necessary depending on the type of product.
What is a Drug OTC Product Licensing Registration?
A Drug OTC Product Licensing Registration is necessary to sell over-the-counter (OTC) medications in Canada. It covers food, cosmetics, and prescription drugs. This ensures that products marketed with reference to these categories are safe to consume and provide a risk-free experience for consumers. To be eligible for registration, you’ll need an active business license, the drug information document (DID), and some other documents. A Drug OTC Product Licensing system has been implemented in Canada to ensure that only the most qualified people or those that meet the necessary regulatory conditions can make claims (monopolize) of drug-related products. To apply for a Drug OTC Product Licensing registration, you need to provide certain proof such as your company’s formal documents and the course leads completed.
Who can apply for a Drug OTC Product Licensing Registration?
First, your product should be a Health Canada approved drug. Next, you can apply for an application with Health Canada and have the company name listed on the Drug OTC Product Licensing Registration document. Only permitted sellers of OTC drugs can apply for the Drug OTC Product Licensing registration. They must complete the application form, meet specific requirements and attest that their product has not been previously marketed in Canada.
How do I apply for my Drug OTC Product Licensing Registration?
The Health Canada Drug Review Panels (DRC) program considers the quality of medical evidence and responds with a determination on whether or not the product is therapeutically comparable. If it isn’t comparable, the drug can carry any other name. So if your drug is not listed in the review panels, you will need to get a certification from Health Canada to be able to market it under a different name. To obtain your permit, you need to:
How long does it typically take before I complete my application?
Gaining permission to market your drug in Canada is time-consuming and rigorously evaluated, but it’s easier than you might think. The process typically takes between four and six months to finish, but there is still time before the application deadline in December. If your drug product is eligible for licensing this year, now is the time to apply.
Food and Drug Regulations stipulate that a company needs to have a Canadian license between 12 months and 18 months of submitting the application. If you are in urgent need of getting a drug approved for publication, it is possible to submit an OTC product without going through the licensing process. However, submissions without licenses will likely be difficult to secure from health Canada approval as well as possibly not being accepted by licensee companies in Canada.
Conclusion
The first step is to know the laws in Canada related to drugs and drug products. Permits, approvals and licensing are required before your pharmacist can dispense the new OTC product. Apply for a permit first with INDEX-MCC then prepare the dossier by gathering all of the documentation that is required with INDEX-MCC. Then submit this paperwork with Regulatory Affairs Canada to Interpolate their app on their prescribed services database.
