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Drugs and Health Products

Lot Release - Guidance Documents - Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies

Section C.04.015 of the Food and Drugs Act and Regulations, states that "on written request from the Director, every fabricator, packager/labeller, tester, distributor ... and importer of a drug shall submit protocols of tests together with samples of any lot of the drug before it is sold ..." Based upon the assessment of several factors, such as the regulatory status, how well-characterized a product is, testing history, inspection history, and the product safety status, BGTD establishes a risk profile for each product, and assigns it, one of four review/ testing/ approval categories. These categories further describe what a sponsor needs to submit as part of the lot release programme (e.g. test samples, protocols, notifications, annual status reports), as well as the level of review and testing that BGTD will conduct either prior to product approval (e.g. Category 1a or 1b) and prior to the release of each lot that will be marketed in Canada (e.g. Category 2, 3 or 4).

This work is carried out by BGTD throughout the life-cycle of a product in Canada. The review and testing requirements are reviewed periodically to ensure that the appropriate level of scrutiny is applied for each product, in line with its historical profile.