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Commission Directive 2009/9/ECShow full title
Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance)
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CHAPTER II:U.K.PRESENTATION OF PARTICULARS AND DOCUMENTS
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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