TERMS OF REFERENCE CGPA/PMPRB WORKING GROUP ON GUIDELINES PERTAINING TO THE PRICING OF PATENTED GENERIC DRUG PRODUCTS

Revised February 7, 2008

MANDATE

The mandate of the Working Group (WG) is to provide advice and options for changes to the Guidelines and Regulations that would recognize the environment in which generics are sold for consideration by the Board.

DELIVERABLES

  1. Advice and options for changes to the Guidelines and Regulations pertaining to the review of patented generic drug products.
  2. Background information supporting the advice and options.

REPORTS & TIMEFRAME

Status/progress report to Board by March 5, 2008

Report to the Board by the end of April 2008 Presentation to the Board on advice and options in May 2008

MEMBERSHIP

The Working Group (WG) shall be composed of members from the PMPRB and CGPA including:

  • Senior PMPRB staff members including the Executive Director.
  • Members appointed from the generic pharmaceutical companies as well as the President of the Canadian Generic Pharmaceutical Association.

Records of decisions and action steps will be prepared for meetings of the Working Group and circulated to all participants.

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