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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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For particular groups of substances or if the effects observed during repeated dose studies in animals include changes indicative of e.g. immunotoxicity, neurotoxicity- or, endocrine dysfunction, further testing shall be required, e.g. sensitisation studies or delayed neurotoxicity tests. Depending on the nature of the product, it may be necessary to conduct additional studies to assess the underlying mechanism of the toxic effect or the irritation potential. Such studies shall usually be conducted with the final formulation.
The state of scientific knowledge and established guidance shall be taken into account when designing such studies and evaluating their results.
The potential microbiological risk presented by residues of antimicrobial compounds for the human intestinal flora shall be investigated in accordance with established guidance.
In certain cases, it may be necessary to carry out tests to determine whether microbiologically active residues may interfere in technological processes in the industrial processing of foodstuff.
Information shall be provided showing whether the pharmacologically active substances of the veterinary medicinal product are used as medicinal products in human therapy; if this is so, a compilation shall be made of all the effects observed (including adverse reactions) in humans and of their cause, to the extent that they may be important for the assessment of the safety of the veterinary medicinal product, where appropriate including results from published studies; where constituents of the veterinary medicinal products are themselves not used or are no longer used as medicinal products in human therapy, the reasons shall be stated.
Data on the potential emergence of resistant bacteria of relevance for human health are necessary in the case of veterinary medicinal products. The mechanism of the development of such resistance is particularly important in this regard. Where necessary, measures to limit resistance development from the intended use of the veterinary medicinal product shall be proposed.
Resistance relevant for clinical use of the product shall be addressed in accordance with Part 4. Where relevant, cross reference shall be made to the data set out in Part 4.]
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