# 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 1: Identification of the product

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

An identification of the veterinary medicinal product(s) used in the testing shall be provided, including:
composition,
the physical and chemical (potency and purity) test results for the relevant batch(es),
batch identification,
relationship to the final product,
specific activity and radio-purity of labelled substances,
position of labelled atoms in the molecule.
The dossier of residue tests shall include:
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 GLP can make to the overall risk assessment,
a withdrawal period proposal.
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 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,
an objective discussion of the results obtained, and proposals concerning the withdrawal periods necessary to ensure that no residues which might constitute a hazard for consumers are present in foodstuffs obtained from treated animals.

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Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/II/division/1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-B/chapter-II/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.