Division 4.4 Development of resistance

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.