Commission Implementing Regulation (EU) 2022/140 of 16 November 2021 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to the Union antigen, vaccine and diagnostic reagent banks (Text with EEA relevance)

This Regulation lays down rules for the Union antigen, vaccine and diagnostic reagent banks, specifying: (a) the biological products to be included in the Union antigen, vaccine and diagnostic reagent banks, and the category A diseases for which they may be intended; (b) the requirements concerning types, strains and quantities of the biological products to be included in the Union antigen, vaccine and diagnostic reagent banks; (c) the additional requirements concerning the supply and storage of antigens and vaccines to be included in the Union antigen, vaccine and diagnostic reagent banks; (d) the requirements concerning the formulation of antigens of the foot and mouth disease virus stored in the Union antigen banks into vaccines, and the labelling of ready-to-use vaccines; (e) the procedures for the release and delivery of vaccines from the Union antigen, vaccine and diagnostic reagent banks; (f) the requirements concerning the replacement of antigens, vaccines and diagnostic reagents in the Union antigen, vaccine and diagnostic reagent banks; (g) the procedural and technical requirements for requesting access to the Union antigen, vaccine and diagnostic reagent banks.

For the purpose of this Regulation, the definitions in Article 2 of Delegated Regulation (EU) 2022/139 shall apply.

1 The Commission shall include in the Union antigen, vaccine and diagnostic reagent banks the biological products listed in column 2 of the table in Annex I (‘the table’) for the category A diseases listed in column 1 of the table.

2 The Commission shall maintain in the Union antigen, vaccine and diagnostic reagent banks the types and strains of the biological products listed in column 3 of the table and the quantities of biological products listed in column 4 of the table, and take account of the validity period of the biological products indicated in column 5 thereof.

1 The Commission shall arrange independent testing of the potency and innocuity of the vaccines supplied and stored in the Union vaccine banks and of the vaccines reconstituted from antigens stored in the Union antigen banks.

2 The contracted manufacturer shall comply with the additional requirements concerning the storage of antigens of the foot and mouth disease virus and vaccines against category A diseases set out in Annex II.

1 In the case of an emergency and with due regard to the epidemiological situation in the Union or in third countries or territories where it is in the interest of the Union, the Commission shall request the contracted manufacturer, in writing, for a formulation of antigens of the foot and mouth disease virus stored in the Union antigen banks into vaccines and the bottling, labelling and temporary storage of the necessary quantities of those vaccines.

2 The contracted manufacturer shall comply with the request referred to in paragraph 1 of this Article and the requirements concerning the formulation of antigens of the foot and mouth disease virus into vaccines and the labelling of the ready to use vaccines set out in Annex III.

1 When required, the Commission shall request the contracted manufacturer, in writing, for a delivery of the vaccines stored in the Union vaccine banks or of the formulated vaccines referred to in Article 5(1).

2 The contracted manufacturer shall comply with the request referred to in paragraph 1 of this Article and the procedures for the release and delivery of the formulated vaccines referred to in Article 5(1) set out in Annex IV.

3 The contracted manufacturer shall comply with the procedures for the delivery of vaccines stored in the Union vaccine banks set out in Annex V.

Following the use of any antigen, vaccine or diagnostic reagent from the Union antigen, vaccine and diagnostic reagent banks, the Commission shall ensure that the used antigen, vaccine or diagnostic reagent is replaced, if necessary, by its equivalent, as soon as possible and with due regard to the epidemiological situation.

1 The Commission shall grant Member States access to the Union antigen, vaccine and diagnostic reagent banks upon their written request.

2 The Commission shall, within the limits of availability of stocks of the Union antigen, vaccine and diagnostic reagent banks, immediately arrange for the shipment of the required quantities and types of vaccines or diagnostic reagents, taking into account the criteria laid down in Article 49(2) of Regulation (EU) 2016/429 and the additional criteria for the distribution of the required quantities and types of vaccines set out in Annex VI to this Regulation.

3 Member States that maintain national antigen, vaccine and diagnostic reagent banks or Member States that are associated to an international antigen and vaccine bank shall have the same rights and obligations with regard to the Union antigen, vaccine and diagnostic reagent banks as other Member States that do not have a national antigen, vaccine and diagnostic reagent bank or access to an international antigen and vaccine bank.

4 Where it is in the interest of the Union, the Commission may supply or lend, following their request, to third countries or territories, antigens, vaccines or diagnostic reagents from the Union antigen, vaccine and diagnostic reagent banks.

5 Access of third countries and territories to the Union antigen, vaccine and diagnostic reagent banks shall be granted under detailed conditions agreed between the Commission and the third country or territory concerned.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 May 2022.