This morning, June 29th, 2021, Health Canada announced an additional 6-month delay in implementation of the Patented Medicines Regulations and Final PMPRB Guidelines. The changes will now come into force on January 1, 2022. The reasons cited by Health Canada for the delay are the ongoing COVID-19 pandemic and need for additional time for industry to prepare and comply with the changes. This is the third delay in implementation of the Regulations and Final Guidelines. The amended regulations will be published in the Canada Gazette, Part II on July 21st, 2021.
Reminder & Impact:
PMPRB Form 2 filings are due July 31, 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 Market Access