A New Drug is commonly referred to a brand-name product because it has been created by companies and patented rather than reproduced by competitors.
A generic product must be shown to be as safe and efficacious as the brand-name product, and the submission must meet the same quality standards as a NDS. The ANDS submission involves between 10 and 20 binders of data that shows how the generic product performs compared with the brand-name product.
It includes scientific information as well as details on the production of the generic drug, its packaging and labeling plus comparative bioavailability studies showing how the generic drug can deliver the same amount of medicinal ingredient, at the same rate as the brand-name product. Changes may include the dosage form or strength of the drug product, the formulation, manufacturing method, labeling or recommended route of administration.
If the manufacturer wants to expand the claims or conditions of use indications for the drug product a SNDS must be submitted to Health Canada.
A Drug Identification Number DIN application must be filed for those products that do not meet the definition of a 'new drug'. In these cases, the substance for use as a drug has already been sold in Canada for a sufficient time and quantity to establish the safety and effectiveness of that substance for use as a drug.
Drug Identification Number - How is Drug Identification Number abbreviated?
As part of the DIN application, an acceptable label design is required to show the TPD that the product is not going to be marketed in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition or safety. A DIN identifies the following product characteristics.
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Calgary Travel Clinic. Chinook - Calgary Travel Clinic. Edmonton Travel Clinic. Southeast Edmonton Travel Clinic. Albert Travel Clinic. Abbotsford Travel Clinic.
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