Subject matter and scope
Article 1
This Regulation lays down rules for the Union antigen, vaccine and diagnostic reagent banks, specifying: (a) the biological products to be included in the Union antigen, vaccine and diagnostic reagent banks, and the category A diseases for which they may be intended; (b) the requirements concerning types, strains and quantities of the biological products to be included in the Union antigen, vaccine and diagnostic reagent banks; (c) the additional requirements concerning the supply and storage of antigens and vaccines to be included in the Union antigen, vaccine and diagnostic reagent banks; (d) the requirements concerning the formulation of antigens of the foot and mouth disease virus stored in the Union antigen banks into vaccines, and the labelling of ready-to-use vaccines; (e) the procedures for the release and delivery of vaccines from the Union antigen, vaccine and diagnostic reagent banks; (f) the requirements concerning the replacement of antigens, vaccines and diagnostic reagents in the Union antigen, vaccine and diagnostic reagent banks; (g) the procedural and technical requirements for requesting access to the Union antigen, vaccine and diagnostic reagent banks.