PART III

DISEASE AWARENESS, PREPAREDNESS AND CONTROL
TITLE I

DISEASE AWARENESS AND PREPAREDNESS
CHAPTER 3

Antigen, vaccine and diagnostic reagent banks

National antigen, vaccine and diagnostic reagent banks
Article 52
1
Member States that have established national antigen, vaccine and diagnostic reagent banks for listed diseases referred to in point (a) of Article 9(1) for which Union antigen, vaccine and diagnostic reagent banks exist, shall ensure that their national antigen, vaccine and diagnostic reagent banks comply with the biosecurity, biosafety and bio–containment requirements laid down in point (a) of Article 16(1) and in delegated acts adopted in accordance with Article 16(2) and point (b) of Article 48(3).
2
Member States shall provide the Commission with up–to–date information on:
a
the existence or the establishment of the national antigen, vaccine and diagnostic reagent banks referred to paragraph 1;
b
the types of antigens, vaccines, vaccine master-seed stocks and diagnostic reagents and the quantities thereof held in such banks;
c
any changes in the operation of such banks.
That information shall be treated as classified information by the Commission and shall not be published.
3
The Commission may, by means of implementing acts, lay down rules specifying the content, frequency and format of the submission of the information provided for in paragraph 2.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).