# 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.5.2

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

Batches used in safety studies shall be identified and adequate specifications shall be provided, including purity (concentrations of impurities), isomer ratios and enantiomers, solubility and any other factor that may influence its activity.

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Source: https://www.legislation.gov.uk/eur/2018/782/annex/I/division/II/division/II.5/division/II.5.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.5/division-II.5.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.