CHAPTER IIIPREVENTATIVE MEASURES

SECTION 14ANTIGEN AND VACCINE BANKS

Article 79National antigen and vaccine banks

1

Member States may within the framework of the contingency plan establish or maintain national antigen and vaccine banks for the storage of reserves for emergency vaccination of antigens or vaccines authorised in accordance with Directive 2001/82/EC.

2

Member States may retain establishments for the packaging and storage of vaccines in the case of emergency vaccination.

3

Member States shall ensure that the antigen and formulated vaccine in the national antigen and vaccine banks comply with the minimum standards laid down for the Community antigen and vaccines bank with respect to safety, sterility and content of non-structural proteins.

4

Member States maintaining a national antigen and vaccine bank shall inform the Commission about the antigen and vaccine stocks kept. Such information shall be submitted to the Commission every 12 months as part of the information required by Article 8 of Directive 64/432/EEC. The information on quantities and subtypes of antigens or authorised vaccines stored in the national antigen and vaccine bank shall be treated as classified information and in particular shall not be published.