2.

For the purposes of paragraph 1, the Commission shall issue a call for tenders, taking into account the following criteria in particular: the technical requirements concerning the supply of antigens, in accordance with Annex II; (b) the supply and delivery of the specified quantity to the antigen bank in a form suitable for long-term storage in liquid nitrogen, or other storage methods recognized, under the procedure laid down in Article 10 after obtaining the opinion of the Scientific Veterinary Committee, as giving at least equivalent stability, including the provision of separate replicates suitable for routine testing; (c) a guarantee that any antigen supplied will meet the safety and stability requirements defined for vaccine by the European Pharmacopoeia, as well as the required potency (6 PD 50/dose) when tested as specified for vaccine; (d) the reagents and materials to be used in the formulation of the vaccine; (e) a guarantee that the vaccine supplied complies fully with the European Pharmacopoeia; (f) supply of the vaccine, within a given time and at a guaranteed rate of delivery, in bottles of suitable size, labelled in the language or languages of the country in which the vaccine is to be used; (g) compliance by the establishment which supplies an antigen with the 'minimum standards for laboratories working with foot-and-mouth disease virus in vitro and in vivo` - European Commission for the control of foot-and-mouth disease - 26th session, Rome, April 1985, on the basis, where necessary, of a report by experts acting under the procedure laid down in Article 10; (h) quoted costs for the supply of the antigen or the provision of the service, as appropriate.

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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.