# Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, Division CHAPTER II:: PRESENTATION OF PARTICULARS AND DOCUMENTS

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

The dossier of safety tests shall include the following:
an index of all studies included in the dossier,
a statement confirming that all data known by the applicant at the time of submission, whether favourable or unfavourable, are included,
a justification for the omission of any type of study,
an explanation of the inclusion of an alternative type of study,
a discussion of the contribution that any study that pre-dates studies performed in line with good laboratory practice (GLP) according to Directive 2004/10/EC can make to the overall risk assessment.
Each study report shall include:
a copy of the study plan (protocol),
a statement of compliance with good laboratory practice, where applicable,
a description of the methods, apparatus and materials used,
a description and justification of the test system,
a description of the results obtained, in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author,
a statistical analysis of the results where appropriate,
a discussion of the results, with comment on observed and no-observed-effect levels, and on any unusual findings,
a detailed description and a thorough discussion of the results of the study of the safety profile of the active substance, and its relevance for the evaluation of potential risks presented by residues to humans.

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Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/II (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-A/chapter-II
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.