10.

results of: - physico-chemical, biological or microbiological tests, toxicological and pharmacological tests, clinical trials. The results of the toxicological and pharmacological tests must relate more particularly to the metabolism of the active ingredients in the animal and as far as possible to the mode and duration of their elimination, if such data are important for the purpose of checking the indicated withdrawal period. However, (a) a copy of the published references relating to the toxicological and pharmacological tests and clinical trials and the data concerning the withdrawal period may be substituted for the relevant test results in the case of: (i) a veterinary medicinal product with an established use, which has been adequately tested on animals so that its effects, including side-effects, are already known and are included in the published references; a new veterinary medicinal product, in which the active ingredients are identical to those of a known medicinal product with an established use; a new veterinary medicinal product containing only known constituents that have already been used together in comparable proportions in adequately tested medicinal products with an established use; in the case of a new veterinary medicinal product containing known constituents not hitherto used together for therapeutic purposes, references to published data may be substituted for the tests on such constituents;

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.