Market authorization holders (MAH) of generic drug products regulated under Division 8 of the Food and Drug Regulations are required to file submissions to update their labelling to ensure consistency with that of the Canadian Reference Products (CRP) labeling.
On a monthly basis, Health Canada posts the Product Monograph Brand Safety Updates table. This table displays updates and/or new safety information in product monographs (PMs) of brand name pharmaceutical drug products.
Submissions to update generic PMs should be filed within 30 days of the posting date of the Product Monograph Brand Safety Updates table. Sponsors are also required to submit an attestation form certifying that the submitted generic PM is updated according to the most recent PM of the Canadian Reference Product (CRP).
Generic drug product manufacturers should check the Product Monograph Brand Safety Updates table on a regular basis to ensure timely submission of updates to generic PMs.
In addition to the Product Monograph Brand Safety Updates table, Health Canada, may still contact generic drug product manufacturers directly to request PM updates.
For monthly Product Monograph Brand Safety Updates visit http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_rep_rap_eval_etiq-eng.php