Regulations amending the Patented Medicines (Notice of Compliance) Regulations
The proposed regulations would amend the Patented Medicines (Notice of Compliance) Regulations to change patent listing criteria to align with changes made to Health Canada's Food and Drug Regulations. The proposed amendments to the Regulations are required to ensure that the scope of protection under the Regulations corresponds to the type of activities contemplated under the proposed amendments to the Food and Drug Act Regulations.
Regulatory cooperation efforts (domestic and international)
The proposal is unrelated to a work plan or commitment under a formal regulatory cooperation forum.
Potential impacts on Canadians, including businesses
The amendments, paired with the proposed changes to Health Canada's Food and Drug Act Regulations, are consistent with the existing linkage system that balances the enforcement of IP rights held by innovative pharmaceutical manufacturers and the timely approval of generic drug approvals for generic pharmaceutical manufacturers.
The proposed amendments were pre-published in April 2021. Stakeholders representing the innovative manufacturer sector were supportive of the changes and the alignment with the proposed Food and Drug Act regulations. The generic pharmaceutical industry expressed concern that the proposed amendments could result in delayed introduction of new generic medicines, including in circumstances where neither the innovative manufacturer nor the generic manufacturer is making use of the invention claimed in the newly listable patent.
Final publication is anticipated in Fall 2022.
Additional information can be sought from the department.
Departmental contact information
Erin CampbellDirector, Marketplace Framework Policy Branch
Innovation, Science and Economic Development Canada / Government of Canada
firstname.lastname@example.org / Tel: 343-291-3783
Date the regulatory initiative was first included in the Forward Regulatory Plan
Forward Regulatory Plan 2021–2023
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