Consultation on Potential Changes to the Patented Medicines Regulations
On May 16, 2017, the Honourable Jane Philpott, Minister of Health, outlined a comprehensive plan for improving the pharmaceutical system in Canada. Included in the plan was the launch of a consultation process on potential changes to the Patented Medicines Regulations (Regulations) that would lower the cost of prescription drugs in Canada and better protect Canadians against excessive drug prices.
This online consultation is open for a 45-day period, ending June 28, 2017. The Minister has indicated that it is her intention to seek Treasury Board approval to pre-publish proposed regulatory amendments in Canada Gazette, Part I in the ensuing months. Given the interdependency of the Regulations and the Guidelines, the PMPRB will await the outcome of that process before officially resuming its consultations on Guideline modernization.
May 2017 Human Drug Advisory Panel Meeting – Rescheduled
Due to scheduling conflicts, the second Human Drug Advisory Panel meeting of 2017, originally set for May 29, 2017, has been moved to June 5, 2017. Patentee submission deadlines for this meeting are unchanged.
Reminder to Patentees: Procedures for Amending Form 2 Regulatory Data
To prevent delays in the price review process, patentees are reminded that they are required to provide a written explanation to support any revisions made when filing one or more amendments to Block 4 or Block 5 data. The explanation may be submitted to the PMPRB by email or in a cover letter as an email attachment.
Amended Form 2 (information on the identity and prices of the medicine) – Block 1, 2, and 3 data must be completed, signed, dated, and submitted electronically to compliance@pmprb-cepmb.gc.ca, along with any amended Block 4 and 5 data.
Other news include:
- Status of ongoing proceedings: Soliris
- NPDUIS Update: Publications and engagement activities
- Voluntary Compliance Undertaking: GlaxoSmithKline Inc.
- Correction: Status of ongoing proceedings updates (February 2017 and November 2016)
- Update: Interpretation Policy
For more information, please consult the May 2017 PMPRB NEWSletter found here.