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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
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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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