Requirements concerning the formulation of antigens of the foot and mouth disease virus into vaccines and the labelling of the ready-to-use vaccine
Article 5
1. In the case of an emergency and with due regard to the epidemiological situation in the Union or in third countries or territories where it is in the interest of the Union, the Commission shall request the contracted manufacturer, in writing, for a formulation of antigens of the foot and mouth disease virus stored in the Union antigen banks into vaccines and the bottling, labelling and temporary storage of the necessary quantities of those vaccines. 2. The contracted manufacturer shall comply with the request referred to in paragraph 1 of this Article and the requirements concerning the formulation of antigens of the foot and mouth disease virus into vaccines and the labelling of the ready to use vaccines set out in Annex III.