# 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 3.6: Carcinogenicity

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

The decision on whether carcinogenicity testing is required shall take into account the results of genotoxicity tests, structure-activity relationships and the findings in systemic toxicity tests that may be relevant to neoplastic lesions in longer term studies.
Any known species specificity of the mechanism of toxicity shall be considered, as well as any differences in metabolism between the test species, target animal species, and human beings.
Where carcinogenicity testing is necessary, generally a two-year rat study and an 18-month mouse study are required. With appropriate scientific justification, carcinogenicity studies may be carried out in one rodent species, preferably the rat.

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Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.6 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-A/chapter-I/division-3/division-3.6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.