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:
- (a)
rapid formulation into vaccine of the antigen referred to in Article 81;
- (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;
- (c)
a capacity to formulate from concentrated inactivated antigen in stock:
- (i)
up to one million doses of vaccine within four days of instruction from the Commission;
- (ii)
additionally, up to four million doses of vaccine within 10 days of instruction from the Commission;
- (i)
- (d)
rapid bottling, labelling and distribution of the vaccine according to the specific needs of the area where vaccination is to be carried out.