Biosecurity, biosafety and bio-containment requirements for the operation of the Union antigen, vaccine and diagnostic reagent banks
Article 10
The Union antigen, vaccine and diagnostic reagent banks shall operate at least in accordance with the following biosecurity, biosafety and biocontainment requirements: (a) the facilities where the antigens, vaccines and diagnostic reagents are stored shall: (i) comply with the recognised quality standards provided for in international standards referred to in point 3 of Annex I and in point 4 of Annex II; (ii) be subjected to controls by the Commission to ensure continuous compliance with the recognised quality standards referred to in point (i), in addition to regular and risk-based controls by the competent authorities; (iii) be secure and protected from accidental or intentional damage, including microbial contamination; (b) where a Union antigen, vaccine or diagnostic reagent bank is co-located with a laboratory or other facility where pathogens are handled, the storage facilities referred to in point (a) shall be effectively protected from contamination by physical separation and biosafety procedures for the personnel; (c) the personnel shall, where they have had possible exposure to relevant pathogens of the category A diseases referred to in Article 3(1) or 5(1), comply with a quarantine procedure before entering the Union antigen, vaccine and diagnostic reagent banks.