Accessible text for the pan-Canadian Price Tier Market Exit Eligibility Flowchart.
Version Date: February 19, 2025
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.
- If the submission does not pass pCPA evaluation, continue to Stage 4A
- If the submission passes pCPA evaluation, 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 MFRs (“no” at stage 3).
- 4B: Market exit TPF application is processed by the pCPA. The pCPA will process the submitted market exit TPF Form and will recommend delisting of an exiting DIN/NPN to all jurisdictions.