# Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance), Division II.4.1

Extent: E+W+S+N.I.

A detailed and critical summary of the safety file shall be required.

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Source: https://www.legislation.gov.uk/eur/2018/782/annex/I/division/II/division/II.4/division/II.4.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.4/division-II.4.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.