Commission Implementing Regulation (EU) 2025/2154 Article 35

Time limits

Article 35

Whenever time limits are specified in the master production instructions, those time limits shall be met to ensure the quality of active substances and intermediates thereof. Time limit deviations shall be documented and evaluated.

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Other provisions in CHAPTER VIII — PRODUCTION AND IN-PROCESS CONTROLS

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

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