Commission Implementing Regulation (EU) 2025/2154 Article 4

Implementation of a quality management system

Article 4

1. Manufacturers shall have in place a comprehensive quality management system designed to ensure the quality of active substances. 2. Compliance with good manufacturing practice and the terms of the marketing authorisation, when applicable, shall be an essential part of the quality management system.

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Other provisions in CHAPTER II — QUALITY MANAGEMENT SYSTEM

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 4 of Commission Implementing Regulation (EU) 2025/2154 (LawPlayer, data as of 2026-07-04)

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