July 1, 2021. The amendments delaying the coming-into-force date (see here) will be published in the Canada Gazette II on January 20, 2021. Accordingly, the reporting requirements due by January 31, 2021 of sales and pricing information for the period from July 1, 2020 to December 31, 2020 will be governed by the current Regulations.
These new regulations - officially titled
Regulations amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), No. 2 - push back the timelines for reporting a cost-utility analysis prepared by a publicly funded Canadian organization under new section 4.1(4) and estimated maximum use of the medicine under new section 4.2(4) by
six months. Similarly, section 4.4 will require the Board to consider excessive pricing based on the three new pharmacoeconomic factors for sales in Canada after