Division 2 Safety of one administration of an overdoseF1

Only live immunological veterinary medicinal products require overdose testing.

An overdose of the immunological veterinary medicinal product shall be administered by each recommended route(s) of administration to animals of the most sensitive categories of the target species, unless the selection of the most sensitive of several similar routes is justified. In the case of immunological veterinary medicinal products administered by injection, the doses and route(s) of administration shall be chosen to take account of the maximum volume, which can be administered at any one single injection site. The animals shall be observed and examined for at least 14 days after administration for signs of systemic and local reactions. Other criteria shall be recorded, such as rectal temperature and performance measurements.

Where appropriate, these studies shall include detailed post-mortem macroscopic and microscopic examinations of the injection site if this has not been done under point 1.