Council Directive 2003/85/ECShow full title

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)

Article 84U.K.Testing of foot-and-mouth disease vaccines

1.The Commission shall be responsible for arranging independent testing for potency and innocuity of vaccines reconstituted from antigen stored in the Community antigen and vaccine bank, and of vaccines reconstituted from other antigens and intended for use within the framework of Community assistance to control measures against foot-and-mouth disease in third countries in accordance with Articles 82(2) and 83(3).

2.For the purpose of the testing referred to in paragraph 1 the Commission may employ the services of an independent Community Coordinating Institute.

If necessary, the Community Coordinating Institute shall be designated, and detailed rules on its functions, responsibilities and Community financial contributions shall be adopted, in accordance with the procedure referred to in Article 89(2).

3.Without prejudice to the standards for potency, safety and production procedures provided for in Community legislation, vaccines reconstituted from antigen stored within the Community antigen and vaccine bank shall meet at least the minimum standards for potency, safety and production procedures laid down in the European Pharmacopoeia and the relevant provisions of the OIE Manual.