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)
Commission Implementing Regulation (EU) 2022/140of 16 November 2021laying 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")OJ L 84, 31.3.2016, p. 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) 2018/1882Commission 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)., 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) 2022/139Commission 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). 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: