# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 5.9.2: Direct observation, e.g. clinical cases and poisoning incidents

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

Available reports from the open literature, relating to clinical cases and poisoning incidents, where they are from refereed journals or official reports, must be submitted together with reports of any follow-up studies undertaken. Such reports shall contain complete descriptions of the nature, level and duration of exposure, as well as the clinical symptoms observed, first aid and therapeutic measures applied and measurements and observations made. Summary and abstract information is not of value.
Where supported with the necessary level of detail, such documentation can be of particular value in confirming the validity of extrapolations from animal data to man and in identifying unexpected adverse effects which are specific to humans.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/5/division/5.9/division/5.9.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.9/division-5.9.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.