Health Canada has announced that the implementation of the Patented Medicines Regulations and Final PMPRB Guidelines has been delayed for 6 months to July 1, 2021. Health Canada stated that the primary reason for the delay are the challenges posed by COVID-19 for all stakeholders. Additionally, Health Canada stated the delay will provide the industry with additional time to prepare for the new reporting obligations and to familiarize themselves with the PMPRB’s Final Guidelines. The amendment was communicated to select stakeholders on December 29, 2020 and will be published in Canada Gazette II on January 20, 2021. An official Health Canada notification to all stakeholders is expected later today.
Reminder & Impact:
PMPRB Form 2 filings are due January 30, 2021. Since the current Regulations remain in force, the January filing requirements will be as per the current Regulations and Guidelines, including reporting sales data by class of customer and province, and filing Block 5 information based on the PMPRB7 basket of international reference countries. As always, PDCI is staying very close to this issue for our clients. We will continue to provide further insights as more information becomes available.
For inquiries on how PDCI can help with navigating your pricing needs, please contact Kimberly Robinson, Director, Pricing and MarketAccess