Changes permit emergency import of bulk quantities of foreign-authorized medications
The Government of Canada is committed to making treatment options available to patients who require them in emergency situations, including the current the opioid crisis. The Government is taking action in a number of areas to address the impacts of problematic substance use, including supporting better treatment options for patients.
To help respond to this need, Health Canada is proposing to allow the importation and use of medications that have been authorized for sale in the United States, the European Union or Switzerland, but are not yet authorized in Canada.
Once this process is implemented, the most immediate need is expected to be for drugs to treat opioid use disorder (addiction); however, drugs for pandemic use or other public health emergencies could also be approved for importation through this new process.
Health Canada will work with public health officials as soon as the new regulations come into force, and will explain the process for requesting access to a drug. To access a drug through this new process, public health officials would send a request to Health Canada and provide key information on the drug, the urgent public health need, and how the drug is expected to help those in need in jurisdiction. Once approved, the name and other details of the drug, such as the countries from which the drug could be imported, would be published on Health Canada’s website.
The drug would remain active on the list for one year, after which it would be removed unless Health Canada received a request for continued access. As with any drug sold in Canada, Health Canada would be able to issue a recall or take other necessary actions to protect the health and safety of Canadians should a safety concern arise.
Because of the urgent nature of the proposal, the consultation period for Canadians to share their views has been shortened to 15 days.
Our response to the opioid crisis is and will continue to remain, comprehensive, collaborative, compassionate and evidence-based.
“Our government is determined to working with our partners to help reduce the harm to citizens and communities that is associated with problematic substance use. That includes providing effective and compassionate approaches that help health professionals respond to this and other public health crises.
Jane Philpott – Minister of Health
Photo from: ahrq.gov