Market Withdrawals
How is Patient Access Maintained When a Product is Withdrawn from the Market?
A product market withdrawal, whether due to loss of a Marketing Authorization or a strategic commercial decision, can disrupt patient access to essential therapy. In most jurisdictions, continued supply is permitted on a Named Patient Supply basis when the product retains valid marketing authorization in another market.
Tanner Pharma enables compliant Named Patient Supply following commercial exit, ensuring ethical continuation of treatment on a for-charge basis.
We manage regulatory coordination, pharmacovigilance alignment, and controlled distribution to maintain continuity of supply while allowing marketing authorization holders to responsibly withdraw from commercial operations.
Scenarios for Market Withdrawals
When a product authorized for marketing with a conditional approval does not meet conditions established by a regulator to maintain the marketing authorization
The market value of a product in a country does not justify maintaining a marketing authorization and continued investment to commercialize the product
Pricing for the product in a market presents a reference pricing risk in other countries
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1. Can we withdraw a product commercially while continuing to support existing patients?
Yes. In many jurisdictions, local regulations permit continued supply on a Named Patient Supply basis when a product retains a valid Marketing Authorization in another country. Tanner enables this compliant pathway, allowing Sponsors to exit a market commercially while ensuring continuity of treatment for existing patients.
2. What responsibilities does Tanner manage during a market withdrawal?
Tanner manages the operational and compliance requirements associated with post‑withdrawal supply, including regulatory coordination, pharmacovigilance alignment, and controlled distribution. This allows Sponsors to avoid maintaining full in‑country commercial infrastructure while meeting regulatory obligations and patient access expectations.
3. Is Market Withdrawal support a short‑term or long‑term solution?
Market Withdrawal support is designed as a defined, controlled continuity solution following commercial exit. The structure and duration are tailored to the Sponsor’s withdrawal strategy, regulatory requirements, and ongoing patient need, ensuring ethical and compliant continuation of supply without re‑entering full commercial operations.
Core Services
Supply Chain & Logistics
Program Management
Pharmacovigilance
Regulatory Compliance
Regulatory Compliance
Quality Assurance
Program Management
Pharmacovigilance
Supply Chain & Logistics
Quality Assurance
How We Deliver Access Solutions
Explore real-world examples of how we navigate regulatory, geographic and supply complexities to deliver compliant, global access to essential therapies.