Division 3.7 Exceptions

Where a veterinary medicinal product is intended for topical use, systemic absorption shall be investigated in the target animal species. If it is proved that systemic absorption is negligible, the repeated dose toxicity tests, the tests for reproductive toxicity and the carcinogenicity tests may be omitted, unless:

• under the intended conditions of use laid down, oral ingestion of the veterinary medicinal product by the animal is to be expected, or

• under the intended conditions of use laid down, exposure of the user of the veterinary medicinal product by other routes than the dermal route is to be expected, or

• the active substance or metabolites may enter foodstuffs obtained from the treated animal.