During the current COVID-19 pandemic, the government’s regulatory bodies have decided to take supportive steps to discourage the spread of the virus. These steps include temporarily modifying the regulatory process for disinfectant and sanitization products to allow expedited approvals and releases of new, existing, and modified products onto the Canadian market. These products include hand sanitizers, washes/soaps, and other disinfectants that are in high demand and are currently experiencing shortages.
Health Canada released a DEL Bulletin, No.74 Disinfectants and Hand Sanitizers, on March 17th with clarifications that followed on March 20th containing details on licensing requirements for disinfectant and sanitization products. Health Canada also released a proactive action plan to increase domestic capacity of these in demand products. The interim regulations will allow disinfectant and sanitization products authorized or registered in the US, MRA or a PIC/S jurisdictions to be imported and sold in Canada to assist with the supply and demand. This will permit these products to be imported and sold in Canada in the interim, even though they do not meet the full Canadian labelling and licensing requirements.
Facilities that currently possess a Drug Establishment License (DEL) or Site License (SL) can begin importing new products once they notify Health Canada of the product, update their import license to include the foreign manufacturer(s)/packager(s)/labeler(s) of the product (which also can be expedited because of this current process), and must maintain the appropriate records on file. Health Canada has also encouraged pre-authorized facilities capable of retooling to begin producing sanitization products.
Health Canada is putting in their best efforts to minimalize the spread of COVID-19 and to assist Canadians with obtaining products to help prevent them from contracting the virus. The release of these new interim regulations to expedite the production and importation of disinfectant and sanitization products is a step towards achieving a future without the virus. Let’s hope the future is soon.
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