ALERT: Health Canada to Nearly Double “Drug” Fees Imposed on CGA Members

June 13, 2019

On May 29, 2019, Heath Canada published a revised fee schedule for drugs and medical devices in the Canada Gazette, Part II: Vol. 153, No. 11. The stated intent of the revised fee schedule is to recover more of the costs for Health Canada’s regulatory activities from industry.

“The revised fees…will have a significant…impact on CGA members, with some fees increasing 40% or more.”

The revised fee schedule takes effect on April 1, 2020 and will affect fees paid by CGA members for Drug Establishment Licenses (DEL) and Drug Identification Numbers (DIN). The methodology Health Canada used to determine the revised fees and elimination of most cost mitigation measures will have a significant, and seemingly disparate impact on CGA members, with some fees increasing 40% or more.

CGA is exploring approaches to engage with Health Canada to discuss the impact the revised fees will have on members.