Drug (pharmaceutical) product
A drug 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.
Therefore, to sell a drug in Canada, the manufacturer must have a drug identification number (DIN) and an establishment license delivered by the TPD.
Who is affected by this regulation ?
Manufacturers
Packers
Labellers
Importers
Distributor
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 establishment licence when there are reasonable motive to believe that it is necessary to do so to prevent injury to the health of a purchaser or consumer of a drug 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.