Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (Text with EEA relevance) (c. 85)

ANNEX XIV U.K. COMMUNITY 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: 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.