Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and discontinuances. Through a consultation process, Health Canada is seeking input on the proposed amendments and draft guides from manufacturers, distributors, wholesalers and other industry stakeholders.
The proposed amendments mirror steps taken in the United States, France and Australia. They aim to better allow Health Canada to detect when there is a shortage risk, intervene proactively to attempt to prevent the shortage, and respond effectively if a shortage occurs.
With respect to pharmaceuticals, Health Canada’s proposed amendments would: (1) require market authorization holders to maintain safety stocks and shortage prevention and mitigation plans for select drugs; (2) require drug importers and wholesalers to report surges in demand for select pharmaceutical products to the Minister of Health; and (3) allow the Minister of Health to increase pharmaceutical availability by extending expiration dates in certain cases.
With respect to both pharmaceuticals and medical devices, the proposed amendments would improve regulatory frameworks for reporting shortages and discontinuances and update exceptional importation frameworks to allow for pharmaceuticals and medical devices to be used in a broader range of circumstances.
Health Canada’s consultation is open now and will close on March 8, 2025. It can be accessed here. If you have any questions relating to this consultation, or if you would like to discuss further, please contact us at Bennett Jones LLP.