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PMPRB July Newsletter - Summary
Consultation on Guidelines: (ambitious agenda with little time to consider input from stakeholders):
- Communique to be published Aug 18th
- Proposed Guidelines to be published Aug 20th
- Comments due Oct 6th [Note: Brogan Advanced seminar Oct 28 (Mtl) & 29 (TO) see below]
- Board Meeting Oct 22nd
- Final Guidelines published November 17th
VCU's:
- Denavir (cream for cold sores) - repaid $61k and product is no longer sold in Canada.
- Androgel (testosterone gel)- repaid $3.3million
Hearings:
- Nicoderm hearing will be held - pre-hearing scheduled for Nov 21st. Panel does not agree that low priced sales can be used to offset previously accumulated excess revenues.
- Penlac next session is Aug 20th.
- Quadracel Pentacel continues - Nov 25 - 27th and Jan 5-7th
- Apotex (Oct 6)
- Apo-salvent (Sept 29 pre-hearing)
- ratio-salbutamol (Oct 27, pre-hearing)
- Copaxone (judicial review - no dates)
New Drug Reviews:
Aldurazyme - enzyme replacement - Category 2 - no comparators
Brogan Seminars
- PMPRB Fundamentals Seminar is being held on September 18 in Montreal and September 19 in Toronto. This is a day-long introduction to the Patented Medicine Prices Review Board rules and policies including Scientific Review Procedures, Excessive Price Guidelines, Compliance and Enforcement Policy and Data Filing. Click_here_for_Fundamentals_Seminar_registration
- PMPRB Advanced Seminar is being held on October 28 in Montreal and October 29 in Toronto. This in-depth, day-long session provides a greater understanding of the PMPRB, especially in the areas of Voluntary Compliance Undertakings, Hearings, Category 2 Drugs, and Category 3 Drugs. Barb Ouellet, Executive Director of the PMPRB, and Ginette Tognet, Director of Compliance at the PMPRB, will join us for a brief presentation in the afternoon. Click_here_for_Advanced_Seminar_registration.
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