art_4__para

The functions and duties of the antigen banks shall be: testing batches of stored antigen for stability, potency and safety at intervals to be determined under the procedure laid down in Article 10, following an opinion from the Scientific Veterinary Committee; (iii) advising on the need for replacement of an antigen if tests indicate that its potency is inadequate; (c) to deliver concentrated inactivated antigen to establishments designated for the formulation, bottling and distribution of the vaccine, at the request of the Commission or a Member State under the conditions provided for in the second and third subparagraphs of Article 13 (3) of Directive 85/511/EEC, for use in the Member State or third country in which the vaccine is to be used.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-08 · Text as adopted (Official Journal); later amendments are not incorporated in this text.