ADDITIONAL CONDITIONS FOR THE SUPPLY AND STORAGE OF CONCENTRATED INACTIVATED ANTIGENS OF THE FOOT AND MOUTH DISEASE VIRUS AS REFFERED TO IN ARTICLE 6(2)
ANNEX IISupplementary provisions
ANNEX II ADDITIONAL CONDITIONS FOR THE SUPPLY AND STORAGE OF CONCENTRATED INACTIVATED ANTIGENS OF THE FOOT AND MOUTH DISEASE VIRUS AS REFFERED TO IN ARTICLE 6(2) 1. Each antigen shall consist of a single homogeneous batch. 2. Each batch shall be split in order to permit its storage in separate storage capacities to prevent, in the case of technical problems, the deterioration or loss of the entire batch. 3. The vaccine produced from the antigens to be supplied shall comply with the position paper on requirements for vaccines against foot-and-mouth disease of the Committee for Medicinal Products for Veterinary use of the European Medicines Agency) ( 1 ) . 4. The antigens shall meet at least the requirements of the European Pharmacopoeia ( 2 ) and the relevant provisions of Chapter 3.1.8 ‘Foot and mouth disease (infection with foot and mouth disease virus)’ of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE), Edition 2021. 5. If not otherwise specified in the documents referred to in point 4, the antigen shall be purified to remove non-structural proteins of the foot and mouth disease virus. The purification shall at least ensure that the residual content of non-structural proteins in vaccines reconstituted from such antigen does not induce detectable levels of antibodies against non-structural proteins in animals which had received one initial and one subsequent booster vaccination. 6. The vaccine reconstituted from the antigens stored in the Union antigen bank must have a marketing authorisation granted by the Commission or by a competent authority in at least one Member State, as applicable, in accordance with: (a) either Chapters 3 and 4 of Title III of Directive 2001/82/EC, or Chapter 1 of Title III of Regulation (EC) No 726/2004, respectively, or, (b) as of 28 January 2022, Chapter III of Regulation (EU) 2019/6. In the absence of suitable vaccines against emerging strains of foot and mouth disease virus, a marketing authorisation may not be required for vaccines reconstituted from high and medium priority or new antigens produced under the same conditions and to the same quality standards as antigens that have a marketing authorisation. 7. Each dose of vaccine produced from antigens stored in the Union antigen bank shall have a potency of at least 6 PD 50 in cattle, and shall be suitable for the emergency vaccination of bovine, ovine, caprine and porcine animals , depending on the request by the Commission. ( 1 ) European Medicines Agency (2004). Position paper on requirements for vaccines against foot-and-mouth disease, EMEA/CVMP/775/02-FINAL 01/12/2004. ( 2 ) https://www.edqm.eu/en