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Commission Regulation (EU) 2025/1101 of 3 June 2025 amending Regulation (EU) 2018/782 concerning the assessment by the European Medicines Agency of maximum residue limits for chemical-unlike biological substances

Commission Regulation (EU) 2025/1101 of 3 June 2025 amending Regulation (EU) 2018/782 concerning the assessment by the European Medicines Agency of maximum residue limits for chemical-unlike biological substances

Regulation (EU) 2025/1101 · Regulation · 2 articles

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

Article 1

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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.’.

Article 2

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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