S.L. 437.50 Art. 74National antigen and vaccine banks.

(1) Malta 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 European Council Directive 2001/82/EC.

(2) The competent authority may retain establishments for the packaging and storage of vaccines in the case of emergency vaccination.

(3) The competent authority 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) In the event that Malta maintains a national antigen and vaccine bank, the competent authority shall inform the European Union Commission about the antigen and vaccine stocks kept. Such information shall be submitted to the European Commission every twelve months as part of the information required by Article 8 of European Council Directive 64/432/EEC. The information on quantities and sub-types 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stored in the national antigen and vaccine bank shall be treated as classified information and in particular shall not be published.