Sunset, Withdraw, Divest-Compliance Without Waste

Retiring a product should free resources—not trigger compliance fire drills.

Without structure, you risk missed notifications, PV gaps, and lingering

obligations that eat budget.

This playbook delivers clean exits. You will manage notifications, address recall

risks, secure records, and coordinate functions so the business can move on with

confidence.

Why disciplined exits matter

• Regulatory trust: Authorities expect orderly withdrawals with complete

documentation.

• Patient safety: PV obligations often continue even after sales stop.

• Operational efficiency: Structured plans prevent last-minute scrambles and

wasted inventory.

• Future approvals: Clean exits protect relationships with regulators and

partners.

Step 1: Catalogue obligations before announcing

• Inventory regulatory, legal, PV, quality, and supply-chain requirements by

region.

• Identify contracts with distributors, payers, and suppliers that require

notice.

• Assess remaining inventory, returns policies, and reimbursement obligations.

• Build a master checklist capturing tasks, owners, due dates, and dependencies.

Step 2: Manage notifications with precision

• Create a global notification matrix covering regulators, distributors,

healthcare providers, payers, and patients if required.

• Assign owners and provide controlled templates for each audience (Dear HCP,

regulatory letters, press releases).

• Track submission and acknowledgement dates in a centralized log.

• Coordinate messaging with Legal, Medical Affairs, and Communications to ensure

consistency.

Step 3: Assess recall and safety risks

• Evaluate residual product in the supply chain and patient use.

• Document risk assessments, stock run-out plans, and monitoring triggers.

• Define communication strategies and escalation paths should safety issues emerge

post-withdrawal.

• Maintain PV surveillance, signal detection, and reporting until obligations

expire.

Step 4: Control records retention and access

• Identify documents to preserve: batch records, change controls, regulatory

correspondence, stability data, PV databases, complaint records.

• Determine retention periods by region and regulatory guidance.

• Store records in validated repositories with clear access controls and audit

trails.

• Plan for eventual destruction once retention periods lapse, documenting

approvals.

Step 5: Coordinate supply-chain run-out

• Align production stop dates with regulatory timelines to avoid surplus stock.

• Manage returns, write-offs, and disposal according to SOPs and environmental

regulations.

• Communicate with wholesalers and distributors about final shipments and

reconciliation expectations.

Metrics that prove a clean exit

• Percentage of notifications completed on time.

• Outstanding obligations by region (PV reports, stability commitments).

• Inspection outcomes post-sunset.

• Cost variance versus planned exit budget.

• Time to close records and deactivate systems.

45-day roadmap

1. Days 1-10: Inventory active sunset/divest projects, document outstanding

obligations, and assess risks.

2. Days 11-20: Build or update the notification matrix, launch priority

communications, and log acknowledgments.

3. Days 21-30: Review PV and quality plans, ensure surveillance continues, and

update risk assessments.

4. Days 31-45: Audit records retention repositories, confirm access, and

prepare closure reports for leadership.

Frequently asked questions

• Do PV responsibilities end immediately? No. Continue reporting and signal

monitoring until regulatory obligations end—document the end date.

• How do we handle global differences? Maintain regional appendices in your

checklist covering specific notification forms, language requirements, and

retention laws.

• What about divestments? Include buyer integration plans, data transfer

agreements, and confirmation of ongoing obligations in the deal closing list.

• How do we ensure lessons learned? Conduct a post-exit review capturing what

worked, gaps, and cost savings.

Sustain the win

Review exit metrics quarterly, refresh templates when regulations change, and

hold debriefs after each sunset to capture lessons. Celebrate clean exits that

freed resources without risking compliance. With a repeatable playbook, you retire

products confidently and prepare for the next growth phase.