# 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.6.1.1

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

Data from the pharmacodynamic studies shall aim to enable the identification and characterisation of the mode/mechanisms of action that underlie the intended therapeutic effects as well as those underlying adverse effects/side effects. These studies shall be designed on a case-by-case basis taking account of available information with regard to the likely pharmacological actions for the substance.

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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.6.1.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.1/division-II.6.1.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.