In section I.7. of Annex I to Regulation (EU) 2018/782, the second paragraph is replaced by the following:
‘The information provided above shall be evaluated in accordance with the guidance published by the European Medicines Agency (“Agency”) in order to determine whether a “no MRL required” classification according to the classification provided for under Article 14(2), point (c), of Regulation (EC) No 470/2009 is appropriate.’.
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 1 of Commission Regulation (EU) 2025/1101 (LawPlayer, data as of 2026-07-04)