What is a medicinal product (drug) ?

A medicinal product is any substance or mixture of substances manufactured, sold or represented for use in:

Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

How are they regulated in Canada ?

Health Canada's Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations. To be done, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations.

Therefore, to sell a drug in Canada, the manufacturer must have a drug identification number (DIN) and a licence of establishment. The manufacturers, packers, labellers, importers, distributors must follow the Canadian Good manufacturing Practices.

Who is affected by this regulation ?

And if I don’t comply with this regulation ?

Health Canada may at any time inspect a site, and suspend or cancel a product or site licence when there are reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a purchaser or consumer of a natural health product. Health Canada may suspend the authorization to sell or import a drug at any time and require the owner of the DIN to recall the product.

What can we do for you ?

We can assist you in your steps with the TPD for the request of a DIN, the request for a licence of establishment, their modification or renewal.

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