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Pharmaceuticals

Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. 

Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by Health Canada. 

MCS Associates has extensive DIN submissions experience, having worked on behalf of many clients. We work with you to review, amend or create your product’s labeling, as required for each submission. 

Drug Submissions: MCS Associates can efficiently handle the entire DIN submission process on your behalf. Let us go to work for you.

• A New Drug Submission (NDS) contains scientific information about the product's safety, efficacy and quality. This involves between 100 and 800 binders of data about its claimed therapeutic value, conditions for use and side effects. Included are the results of both the pre-clinical and clinical studies, drug production, packaging and labeling information. 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.

• Abbreviated NDS (ANDS) are used for generic products. 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.

• A Supplemental NDS (SNDS) must be filed by the manufacturer if certain changes are made to already-authorized products. 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.

• When a product is not a “new drug”, the application to Health Canada’s Therapeutic Product Directorate TPD is called a DIN submission. MCS Associates has extensive experience in the preparation of DIN submissions on behalf of clients. 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.

 

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