GRI

Neuraxpharm France

Enforcement Healthcare & Pharma Sanctions & Fines
Date: 27th Jan, 2025 Source: French National Agency for the Safety of Medicines and Health Products (ANSM) Country: France Original Source

Brief

The inspection of Neuraxpharm France's establishment in Paris, conducted from September 23 to 25, 2024, revealed significant non-conformities and shortcomings. These issues were notified to the establishment on November 27, 2024, following a preliminary letter. The main purpose of this document is to address these non-conformities and shortcomings, specifically related to pharmacovigilance, signal detection, and benefit evaluation. The inspection revealed inadequacies in the means and human resources available for pharmacovigilance obligations, as well as issues with data quality control and signal detection processes. Compliance considerations include implementing adequate measures within 6 months, updating procedures, and ensuring proper governance of safety variations.

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French National Agency for the Safety of Medicines and Health Products (ANSM)

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