Council Directive 2003/85/ECShow full title

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: U.K.

(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;

(d)

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