Division 3 Safety of the repeated administration of one dose

In the case of immunological veterinary medicinal products to be administered more than once, as part of the basic vaccination scheme, a study of the repeated administration of one dose shall be required to reveal any adverse effects induced by such administration. These tests shall be carried out on the most sensitive categories of the target species (such as certain breeds, age groups), using each recommended route of administration.

The animals shall be observed and examined for at least 14 days after the last administration for signs of systemic and local reactions. Other objective criteria shall be recorded, such as rectal temperature and performance measurements.