Canadian importers of pharmaceuticals and medical devices received some good news from Health Canada. The government has amended certain regulations to laws to reduce drug shortages. This reduces the pressure on pharmaceutical and medical device manufacturers in the face of supply chain delays.
These new regulations extend and modify certain measures already in place through two interim orders (IOs). They have been made to help track, prevent and mitigate shortages of key health products in Canada, including drugs and medical devices. The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) amending Food and Drug Regulations and Medical Devices Regulations was published in the Canada Gazette II. When the IOs expire, the regulations won’t lapse.
On November 27th, 2021, the Minister of Health will be allowed to compel information pertaining to drug shortages. In addition, these regulations prohibit the distribution of drugs intended for the Canadian market outside of Canada that would cause or worsen a shortage.
On March 1st, 2022, regulations come into place that end the exceptional importation of biocides and foods for special dietary purposes and introduces temporary flexibilities to allow the sale of products already imported into Canada. Finally, the amendments continue temporary flexibilities related to drug establishment licensing for drug-based hand sanitizer activities.
In addition, the existing framework for the exceptional importation of drugs and medical devices will remain. However, there will be small modifications to clarify how much product can be imported and how long it can be sold.
The regulations also amend the Certificate of Supplementary Protection Regulations. The definition of “authorization for sale” has been amended to exclude exceptional importation for a drug under C.10.008(1). This change is consistent with other exclusions of limited purpose authorizations in these regulations.
If you have any questions, please contact Health Canada by email at hc.prsd-questionsdspr.sc@canada.ca.