In March, Health Canada put in place an interim policy for their regulations for hand sanitizers and disinfectant products. This was in response to the high supply and demand for these types of products due to the COVID-19 pandemic, which caused a 735% increase in demand for sanitization products for the week ending March 14, 2020. These interim regulations allowed companies who weren’t previously manufacturing hand sanitizers and disinfectants to begin doing so to aid with the high demand. These new regulations were labelled as temporary, but no exact end date was released as the end of the sanitization crisis was unclear.
However, due to the short-term success of meeting demands, Health Canada has recently announced the ending of two of the interim regulations for the hand sanitizer and disinfectant product regulations; allowing unilingual labelling for hand sanitizers being sold within a unilingual region and turnaround time of 24 – 48 hours for site licence and product licence applicants. All labelling for hand sanitizer and disinfectant products in Canada must immediately change their labelling to be in both English and French. Those who are currently licensed have until June 8, 2020 to comply with bilingual labelling requirement. All new products going forward will have to comply with this immediately. Please refer to the monograph for the complete labelling regulations for hand sanitizers. As well, the previous quick turnaround time of 24 – 48 hours for site licence and product licence applicants has been removed too. The new regulation states the turnaround time is now approximately 5 – 7 days. This was outlined in Health Canada Bulletin #17 – dated May 14, 2020.
For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA