Commission Implementing Regulation (EU) 2022/140 of 16 November 2021 laying down ... (32022R0140)
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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) 2022/140
- 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)
- Article 1
- Subject matter and scope
- Article 2
- Definitions
- Article 3
- Biological products to be included in the Union antigen, vaccine and diagnostic reagent banks for certain category A diseases
- Article 4
- Additional requirements concerning the supply and storage of antigens and vaccines
- 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
- Article 6
- Procedures for the release and delivery of vaccines
- Article 7
- Requirements concerning the replacement of antigens, vaccines and diagnostic reagents
- 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
- Article 9
- Entry into force and application
- ANNEX I
- Biological products to be included in the Union antigen, vaccine and diagnostic reagent banks as referred to in Article 3
- ANNEX II
- Additional requirements concerning the storage of antigens and vaccines as referred to in Article 4(2)
- A.
- Antigens of the foot and mouth disease virus
- B.
- Vaccines
- ANNEX III
- Requirements concerning the formulation of antigens of the foot and mouth disease virus into vaccines and the labelling of the ready-to-use vaccine as referred to in Article 5
- ANNEX IV
- Procedures for the release and delivery of vaccines formulated from the antigens of the foot and mouth disease virus as referred to in Article 6(2)
- ANNEX V
- Procedures for the delivery of vaccines stored in the Union vaccine banks as referred to in Article 6(3)
- ANNEX VI
- Additional criteria for the distribution of the required quantities and types of vaccines as referred to in Article 8(2)
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