PMPRB Guidelines and Regulations Update
As first disclosed by PDCI last week, the PMPRB Board Chair officially confirmed that the amended Patented Medicines Regulations (“Regulations”) will now come into force on January 1, 2021. These Regulations were published in Canada Gazette II in August 2019 with an original implementation date of July 1, 2020. (Note: Health Canada has confirmed the amended effective date will be included in Canada Gazette II on June 10, 2020)
The announcement goes on to confirm that a revised set of draft Guidelines will be published during the week of June 15, 2020, followed by a 30-day consultation period and acceptance of written comments. Details on timing of Guideline finalization is not specified, but reference is made to announcement about the “next and final” phase of consultations between now and the week of June 15, 2020. PMPRB plans to have a fully operational set of Guidelines in place in time for January 1, 2021.
No other details are provided beyond an assurance that transitional measures will be sufficient to allow patentees to come into voluntary compliance with the Guidelines for both new and existing patented medicines.
The full text of the announcement is available here:PMPRB Guidelines and Regulations Update July 1, 2020.
HOLD THE DATE! PDCI will be hosting a free webinar presenting an analysis of the new Draft Guidelines on June 23rd from 10:30 to noon. Please register at this link.