Accessible text: Historical Products Policy (HPP) exit process

Accessible text for the Exit process flowchart, Historical Products Policy (HPP) page 4.

The following exit process will occur in cases where the pricing category has already been established based on the HPP. Otherwise, refer to the Tiered Pricing Framework (TPF) exit process.

Process

Stage 1: Trigger

Generic manufacturers or pCPA jurisdictions may submit a “Market Exit Notification” to the pCPA indicating a Health Canada Database status change that took place on or after April 1, 2018. Changes to status can include:

  • "Canceled Post Market" on the Health Canada Database
  • "Dormant" on the Health Canada Database
  • "Discontinued w/o stock" on the Drug Shortages Database

Stage 2: Confirmation Form

pCPA to send exiting DIN/NPN manufacturer a form confirming there is no intention to re-enter the Canadian market and outlining additional relevant details.

  • If the Manufacturer confirms exit, continue to Stage 3.
  • If the Manufacturer does not confirm exit, skip to Stage 4A.

Stage 3: pCPA Evaluation

Applies to the 6 month period leading up to the "Market Exit Submission":

Sales < Generic Category (all products with same active ingredient, strength, and brand reference product.) threshold is 0.5% to 2% of current category volume, based on market share history.

When there are three or more remaining generics, market exit will not apply.

  • If there is one remaining generic, it moves from Tier 2 to Tier 1. Price will be reassessed to the marketed generic price prior to entering the HP. Continue to stage 4B.
  • If there are two remaining generics, they move from Tier 3 to Tier 2. Price will be reassessed to the original Tier 2 price (10% cap) or to the prior marketed generic price. Continue to Stage 4B.

Stage 4: Market Exit TPF Application Status

  •  4A: Application is not eligible for processing at this time.  Requesting manufacturer may re-apply. Confirmation from Stage 2 may not be needed as part of the re-application process for previously confirmed manufacturers (“no” at stage 3).
  • 4B: Market exit HPP application is processed by the pCPA. The pCPA will process the submitted market exit form and will recommend delisting of an exiting DIN/NPN to all jurisdictions.