Commission Delegated Regulation (EU) 2022/139 of 16 November 2021 supplementing R... (32022R0139)
INHALT
Commission Delegated Regulation (EU) 2022/139 of 16 November 2021 supplementing Regulation (EU) 2016/429 of the European Parliament and of 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 (Text with EEA relevance)
- COMMISSION DELEGATED REGULATION (EU) 2022/139
- of 16 November 2021
- supplementing Regulation (EU) 2016/429 of the European Parliament and of 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
- (Text with EEA relevance)
- Article 1
- Subject matter and scope
- Article 2
- Definitions
- Article 3
- Rules on the contracts with manufacturers required for the management of the Union antigen, vaccine and diagnostic reagent banks
- Article 4
- Framework supply contracts for the vaccines and diagnostic reagents
- Article 5
- The management of the Union diagnostic reagent banks through grants awarded to European Union reference laboratories
- Article 6
- Conditions for the supply and storage of antigens, vaccines and diagnostic reagents
- Article 7
- Principles of selecting strains and variations of antigens, vaccines and diagnostic reagents
- Article 8
- Destruction and safe disposal of antigens, vaccines and diagnostic reagents
- Article 9
- Buy-back of the antigens for which the validity period has expired
- Article 10
- Biosecurity, biosafety and bio-containment requirements for the operation of the Union antigen, vaccine and diagnostic reagent banks
- Article 11
- Transitional measures
- Article 12
- Entry into force and application
- ANNEX I
- CONDITIONS FOR THE SUPPLY AND STORAGE OF ANTIGENS, VACCINES AND DIAGNOSTIC REAGENTS AS REFERRED TO IN ARTICLE 6(1)
- ANNEX II
- ADDITIONAL CONDITIONS FOR THE SUPPLY AND STORAGE OF CONCENTRATED INACTIVATED ANTIGENS OF THE FOOT AND MOUTH DISEASE VIRUS AS REFFERED TO IN ARTICLE 6(2)
Feedback