Division A INTRODUCTION AND GENERAL REQUIREMENTSF1
United Kingdom
The safety tests shall show the potential risks from the immunological veterinary medicinal product, which may occur under the proposed conditions of use in animals: these shall be evaluated in relation to the potential benefits of the product.
Where immunological veterinary medicinal products consist of live organisms, especially those, which could be shed by vaccinated animals, the potential risk to unvaccinated animals of the same or of any other potentially exposed species shall be evaluated.
The safety studies shall be carried out in the target species. The dose to be used shall be the quantity of the product to be recommended for use and the batch used for safety testing shall be taken from a batch or batches produced according to the manufacturing process described in Part 2 of the application.
In the case of an immunological veterinary medicinal products containing a live organism, the dose to be used in the laboratory tests described in Sections B.1 and B.2 shall be the quantity of the product containing the maximum titre. If necessary the concentration of the antigen may be adjusted to achieve the required dose. For inactivated vaccines the dose to be used shall be that quantity recommended for use containing the maximum antigen content unless justified.
The safety documentation shall be used for assessment of the potential risks which may result from the exposure of human beings to the veterinary medicinal product, for example during its administration to the animal.