Whenever the active substance or intermediate is repackaged in a different type of container than that used originally by the active substance or intermediate manufacturer, stability studies shall be performed to justify assigned expiration or retest dates.
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 69 of Commission Implementing Regulation (EU) 2025/2154 (LawPlayer, data as of 2026-07-04)