# 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.6.1.4

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

Data on the pharmacodynamic effects of a substance shall:
(a)enable to identify/characterise the mode/mechanism of action of the substance;
(b)enable characterisation of the dose-response relationship for relevant pharmacological endpoints;
(c)provide insight into the potential toxic effects of the substance based on knowledge of known effects of other substances with similar pharmacodynamic properties;
(d)aid the understanding of the mechanisms underlying adverse effects seen in toxicology studies;
(e)provide, in certain cases, information on the relevance of effects seen in laboratory animals for humans.

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Source: https://www.legislation.gov.uk/eur/2018/782/annex/I/division/II/division/II.6/division/II.6.1/division/II.6.1.4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.1/division-II.6.1.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.