Guidelines for Pharmacovigilance Market Withdrawal Procedures

1) Purpose

The purpose of this SOP is to outline the procedures for the withdrawal of pharmaceutical products from the market due to safety concerns identified through pharmacovigilance activities.

2) Scope

This SOP applies to all pharmacovigilance, regulatory affairs, and quality assurance personnel involved in the market withdrawal process.

3) Responsibilities

The Market Withdrawal Team is responsible for coordinating and executing market withdrawal activities. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and company policies.

4) Procedure

4.1 Decision to Withdraw

1. Review pharmacovigilance data, adverse event reports, and safety signals to determine the need for a market withdrawal.
2. Consult with senior management, regulatory affairs, and legal teams to confirm the decision to withdraw the product.
3. Notify regulatory authorities of the intent to withdraw the product from the market.

4.2 Withdrawal Planning

1. Develop a market withdrawal plan, including timelines, roles, and responsibilities.
2. Identify all affected products, batches, and distribution channels.
3. Prepare communication materials for stakeholders, including healthcare providers, patients, and distributors.

4.3 Communication and Notification

1. Issue market withdrawal notifications to regulatory authorities, healthcare providers, and distributors.
2. Provide clear instructions for the return or disposal of the withdrawn product.
3. Maintain open communication with all stakeholders throughout the withdrawal process.

4.4 Product Retrieval and Disposal

1. Coordinate with supply chain and distribution teams to retrieve the withdrawn product from the market.
2. Ensure proper documentation and tracking of returned products.
3. Oversee the safe and compliant disposal of the withdrawn product.

4.5 Root Cause Analysis

1. Conduct a thorough investigation to determine the root cause of the issue leading to the market withdrawal.
2. Document findings and implement corrective and preventive actions (CAPAs) to prevent recurrence.
3. Review and update relevant SOPs, processes, and training materials based on investigation outcomes.

4.6 Reporting and Documentation

1. Prepare and submit market withdrawal reports to regulatory authorities, detailing the scope, rationale, and outcome of the withdrawal.
2. Maintain records of all withdrawal-related activities, communications, and documents for audit and inspection purposes.
3. Conduct post-withdrawal reviews to assess the effectiveness of the withdrawal process and identify areas for improvement.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, CAPA – Corrective and Preventive Actions

6) Documents, if any

Withdrawal notifications, withdrawal plan, product return logs, root cause analysis reports, CAPA records.

7) Reference, if any

FDA Guidance for Industry – Market Withdrawals, EU Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use.

8) SOP Version

Version 1.0