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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Article 50(1) thereof,

Whereas:

(1) Regulation (EU) 2016/429 lays down rules for the prevention and control of diseases which are transmissible to animals or humans, including rules for the establishment and management of the Union antigen, vaccine and diagnostic reagent banks. In accordance with Article 48(1) of that Regulation, the Commission may establish and be responsible for managing the Union antigen, vaccine and diagnostic reagent banks for the storage and replacement of stocks of antigens, vaccines, vaccine master seed-stocks and diagnostic reagents for the listed diseases referred to in Article 9(1), point (a) thereof, in respect of which vaccination is not prohibited by a delegated act adopted pursuant to Article 47 thereof. The establishment of Union antigen, vaccine and diagnostic reagent banks would promote attainment of the Union’s animal health objectives by permitting a quick and effective response when the resources of those banks are required in the event of the occurrence of a category A disease, as defined and categorised in Commission Implementing Regulation (EU) 2018/1882 (2), and would represent an efficient use of limited resources.

(2) In addition, Article 47(1) of Regulation (EU) 2016/429 empowers the Commission to adopt delegated acts laying down rules concerning the use of veterinary medicinal products, including vaccines, for the purpose of the prevention and control of listed diseases in terrestrial animals. When Member States allow the use of vaccines in kept and wild terrestrial animals against category A diseases, taking into consideration the criteria set out in Article 46(2) of Regulation (EU) 2016/429, they are also required to take into account the rules laid down in those delegated acts.

(3) In accordance with Article 48(3) of Regulation (EU) 2016/429, the Commission has adopted Delegated Regulation (EU) 2022/139 (3) that supplements Regulation (EU) 2016/429, as regards rules for the management, storage and replacement of stocks of antigens, vaccines and, where relevant, other biological products in the Union antigen, vaccine and diagnostic reagent banks. It also lays down biosecurity, biosafety and bio–containment requirements for the operation of those banks.

(4) This Regulation should lay down the necessary implementing rules to be applied in tandem with the rules laid down in Part III of Regulation (EU) 2016/429 and Delegated Regulation (EU) 2022/139 for the management, storage and replacement of stocks of antigens, vaccines and diagnostic reagents in Union antigen, vaccine and diagnostic reagent banks, and also biosecurity, biosafety and bio–containment requirements for the operation of those banks.

(5) This Regulation should lay down the necessary requirements concerning the types, strains and quantities of the biological products to be included in the Union antigen, vaccine and diagnostic reagent banks. It should also lay down the necessary requirements concerning the supply, storage and replacement of biological products in the Union antigen, vaccine and diagnostic reagent banks, as well as in relation to the formulation of antigens of the foot and mouth disease virus stored in the Union antigen banks into vaccines.

(6) Member States should have access to the Union antigen, vaccine and diagnostic reagent banks. In addition, the Commission should be able to supply or lend antigens, vaccines or diagnostic reagents from the Union antigen, vaccine and diagnostic reagent banks to third countries or territories. Therefore, it is necessary to lay down in this Regulation the procedural and technical requirements for requesting access to the Union antigen, vaccine and diagnostic reagent banks.

(7) As Delegated Regulation (EU) 2022/139 applies from 1 May 2022, this Regulation should also apply from that date.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 Subject matter and scope 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.

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

Article 3 Biological products to be included in the Union antigen, vaccine and diagnostic reagent banks for certain category A diseases 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.

Article 4 Additional requirements concerning the supply and storage of antigens and vaccines 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.

Article 5 Requirements concerning the formulation of antigens of the foot and mouth disease virus into vaccines and the labelling of the ready-to-use vaccine 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.

Article 6 Procedures for the release and delivery of vaccines 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.

Article 7 Requirements concerning the replacement of antigens, vaccines and diagnostic reagents 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.

Article 8 Procedural and technical requirements for requesting access to the antigens, vaccines and diagnostic reagents from the Union antigen, vaccine and diagnostic reagent banks 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.

Article 9 Entry into force and application 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 16 November 2021. For the Commission The President Ursula VON DER LEYEN

(1) OJ L 84, 31.3.2016, p. 1.

(2) Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).

(3) Commission Delegated Regulation (EU) 2022/139 of 16 November 2021 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards the management, storage and replacement of stocks of the Union antigen, vaccine and diagnostic reagent banks and the biosecurity, biosafety and bio-containment requirements for the operation of those banks (See page 1 of this Official Journal).