Commission Delegated Regulation (EU) 2023/361 of 28 November 2022 supplementing R... (32023R0361)
Commission Delegated Regulation (EU) 2023/361 of 28 November 2022 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases (Text with EEA relevance)
- COMMISSION DELEGATED REGULATION (EU) 2023/361
- of 28 November 2022
- supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases
- (Text with EEA relevance)
- PART I
- GENERAL PROVISIONS
- Article 1
- Subject matter and scope
- Article 2
- Definitions
- Article 3
- Prohibitions and restrictions on the use of vaccines in animals for the prevention and control of category A and certain category B diseases
- Article 4
- Prohibitions and restrictions on the use of certain veterinary medicinal products, other than vaccines, in animals, for the prevention and control of category A and B diseases
- PART II
- RULES ON THE USE OF VACCINES FOR THE PREVENTION AND CONTROL OF CATEGORY A DISEASES IN ANIMALS
- CHAPTER 1
- Preconditions
- Article 5
- Preconditions for the use of vaccines for the prevention and control of category A diseases in terrestrial and aquatic animals
- Article 6
- Official vaccination plan for the prevention and control of category A diseases in terrestrial and aquatic animals, and information obligations for the Member States
- CHAPTER 2
- Rules on the implementation of vaccination in terrestrial animals and entry into force
- Section 1
- Vaccination strategies and related disease surveillance
- Article 7
- Vaccination strategies for the prevention and control of category A diseases in terrestrial animals
- Article 8
- Rules for the implementation of emergency suppressive vaccination
- Article 9
- Rules for the implementation of emergency protective vaccination and emergency vaccination in wild animals
- Article 10
- Rules for the implementation of preventive vaccination
- Article 11
- Record-keeping and reporting obligations for emergency and preventive vaccination
- Section 2
- Risk mitigation measures, certification requirements and recovery periods
- Article 12
- Biosafety rules for emergency and preventive vaccination
- Article 13
- Risk-mitigating measures in the vaccination zone when implementing emergency protective vaccination and emergency vaccination in wild animals
- Article 14
- Risk-mitigating measures when implementing preventive vaccination
- Article 15
- Certification requirements for movements of kept animals and products thereof from vaccination zones
- Article 16
- Recovery periods after emergency protective vaccination
- Section 3
- Final provisions
- Article 17
- Entry into force
- LIST OF ANNEXES
- ANNEX I
- PART 1
- CATEGORY A DISEASES FOR WHICH THE USE OF VACCINES SHALL BE PROHIBITED BY MEMBER STATES
- PART 2
- CATEGORY B DISEASES FOR WHICH THE USE OF VACCINES SHALL BE PROHIBITED BY MEMBER STATES
- PART 3
- USE OF CERTAIN VETERINARY MEDICINAL PRODUCTS, OTHER THAN VACCINES, FOR PREVENTION AND CONTROL OF CATEGORY A AND B DISEASES
- (Article 4)
- ANNEX II
- Criteria for the use of a vaccine to prevent and control a category A disease in animals
- PART 1
- 1.
- Vaccination of kept animals
- 2.
- Vaccination of wild animals
- PART 2
- SIMPLIFIED ASSESSMENT OF THE VACCINATION STRATEGY
- ANNEX III
- Information to be included in the official vaccination plan
- PART 1
- 1.
- Kept animals
- 2.
- Wild animals
- PART 2
- SIMPLIFIED INFORMATION TO BE INCLUDED IN THE OFFICIAL VACCINATION PLAN
- ANNEX IV
- Preliminary information to be provided to other Member States and the Commission prior to vaccination
- ANNEX V
- Minimum records on vaccination
- 1.
- Kept animals
- 2.
- Wild animals
- ANNEX VI
- Minimum information to be provided by the competent authority to other Member States and the Commission on the implementation of vaccination
- 1.
- Minimum information to be provided in the reports
- 2.
- Time points and minimum frequency to submit the reports
- ANNEX VII
- Foot and mouth disease (FMD)
- PART 1
- SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF FMD
- PART 2
- SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF FMD
- PART 3
- SPECIFIC CONDITIONS FOR THE PROHIBITION OF MOVEMENTS OF ANIMALS AND PRODUCTS AND FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13, IN VACCINATION ZONES WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF FMD IS CARRIED OUT
- PART 4
- RECOVERY PERIODS FOR FMD FOLLOWING EMERGENCY PROTECTIVE VACCINATION
- ANNEX VIII
- Infection with Rift valley fever virus (RVF)
- PART 1
- SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF RVF
- PART 2
- SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF RVF
- PART 3
- SPECIFIC CONDITIONS FOR THE PROHIBITION OF MOVEMENTS OF ANIMALS AND PRODUCTS AND FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13, IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF RVF IS CARRIED OUT
- PART 4
- RECOVERY PERIODS FOR RVF
- ANNEX IX
- Infection with lumpy skin disease virus (LSD)
- PART 1
- SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF LSD
- PART 2
- SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF LSD
- PART 3
- SPECIFIC CONDITIONS FOR THE PROHIBITION OF MOVEMENTS OF ANIMALS AND PRODUCTS AND FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13, IN VACCINATION ZONES WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF LSD IS CARRIED OUT
- PART 4
- RECOVERY PERIODS FOR LSD FOLLOWING EMERGENCY PROTECTIVE VACCINATION
- ANNEX X
- Infection with peste des petits ruminants virus (PPR)
- PART 1
- SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF PPR
- PART 2
- SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF PPR
- PART 3
- SPECIFIC CONDITIONS FOR THE PROHIBITION OF MOVEMENTS OF ANIMALS AND PRODUCTS AND FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13, IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF PPR IS CARRIED OUT
- PART 4
- RECOVERY PERIODS FOR PPR FOLLOWING EMERGENCY PROTECTIVE VACCINATION
- ANNEX XI
- African horse sickness (AHS)
- PART 1
- SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF AHS
- PART 2
- SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF AHS
- PART 3
- SPECIFIC CONDITIONS FOR THE PROHIBITION OF MOVEMENTS OF ANIMALS AND PRODUCTS AND FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13, IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF AHS IS CARRIED OUT
- PART 4
- RECOVERY PERIODS FOR AHS FOLLOWING EMERGENCY PROTECTIVE VACCINATION
- ANNEX XII
- Classical swine fever (CSF)
- PART 1
- SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF CSF
- PART 2
- SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF CSF
- PART 3
- ANIMALS AND PRODUCTS SUBJECT TO PROHIBITION OF MOVEMENTS AND CONDITIONS FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13 IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF CSF IS CARRIED OUT
- 1.
- Animals and products subject to prohibition of movements
- 2.
- Germinal products subject to prohibition of collection
- 3.
- Conditions for granting a derogation in accordance with Article 13(2), point (b)(ii), Article 13(3), point (b), and Article 13(4), point (b)
- PART 4
- RECOVERY PERIODS FOR CSF FOLLOWING EMERGENCY PROTECTIVE VACCINATION
- ANNEX XIII
- Highly Pathogenic Avian Influenza (HPAI)
- PART 1
- SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF HPAI
- PART 2
- SPECIFIC CONDITIONS FOR THE REINFORCED LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF HPAI
- PART 3
- ANIMALS AND PRODUCTS SUBJECT TO PROHIBITION OF MOVEMENTS AND CONDITIONS FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13 IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF HPAI IS CARRIED OUT
- PART 4
- RECOVERY PERIODS FOR HPAI FOLLOWING EMERGENCY PROTECTIVE VACCINATION
- PART 5
- SPECIFIC CONDITIONS FOR PREVENTIVE VACCINATION OF HPAI
- ANNEX XIV
- Infection with Newcastle disease virus (NCD)
- PART 1
- SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF NCD
- PART 2
- SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF NCD
- PART 3
- ANIMALS AND PRODUCTS SUBJECT TO PROHIBITION OF MOVEMENTS AND CONDITIONS FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13 IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF NCD IS CARRIED OUT
- PART 4
- RECOVERY PERIODS FOR NCD FOLLOWING EMERGENCY PROTECTIVE VACCINATION
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