# 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), Division 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:

Extent: E+W+S+N.I.

(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.

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Source: https://www.legislation.gov.uk/eudr/2003/85/annex/XIV/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-2003-85/annex-XIV/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.