ANNEX XIVCOMMUNITY ANTIGEN AND VACCINE BANK

2.Conditions for the formulation, finishing, bottling, labelling and delivery of vaccines reconstituted from concentrated inactivated antigen supplied to the Community antigen and vaccine bank:

  1. (a)

    rapid formulation into vaccine of the antigen referred to in Article 81;

  2. (b)

    production of a safe, sterile and efficient vaccine with a potency of at least 6 PD50 in accordance with the tests prescribed by the European Pharmacopoeia, and suitable for use in case of emergency vaccination of ruminants and pigs;

  3. (c)

    a capacity to formulate from concentrated inactivated antigen in stock:

    1. (i)

      up to one million doses of vaccine within four days of instruction from the Commission;

    2. (ii)

      additionally, up to four million doses of vaccine within 10 days of instruction from the Commission;

  4. (d)

    rapid bottling, labelling and distribution of the vaccine according to the specific needs of the area where vaccination is to be carried out.