What is a medicinal product (drug)?
A medicinal product is any substance or mixture of substances manufactured, sold or represented for use in:
- the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
- restoring, correcting or modifying organic functions in human beings or animals,
- disinfection in premises in which food is manufactured, prepared or kept”
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.
What can we do for you ? Click here
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BNA Consultants group
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Dorval (Québec) H9S 2M7
Phone: 514 774-1046
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