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)
Disease |
Type of veterinary medicinal product |
Conditions |
Infection with Brucella abortus, B. melitensis, B. suis |
Immunological veterinary medicinal products to diagnose the state of immunity of animals: brucelin |
Their use shall be allowed only in accordance with Delegated Regulation (EU) 2020/688, Delegated Regulation (EU) 2020/689, Delegated Regulation (EU) 2020/686 and Regulation (EU) No 853/2004, or for export purposes |
Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. tuberculosis) |
Immunological veterinary medicinal products to diagnose the state of immunity of animals: tuberculin |
Their use shall be allowed only in accordance with Delegated Regulation (EU) 2020/688, Delegated Regulation (EU) 2020/689, Delegated Regulation (EU) 2020/686 and Regulation (EU) No 853/2004, or for export purposes |
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
|
Emergency vaccination strategy |
Preventive vaccination strategy |
||
Suppressive vaccination |
Protective vaccination |
In wild animals |
||
Description of vaccination and peri-vaccination zones |
WHERE APPLICABLE |
YES |
YES |
WHERE APPLICABLE |
Total number of establishments and total number of establishments in each vaccination zone (where applicable) |
YES |
YES |
NO |
YES |
Total number of animals to be vaccinated, (by species) and total number of animals in each vaccination zone (where applicable). |
YES |
YES |
NO |
YES |
Total number of vaccinated establishments (in each vaccination zone where applicable) |
YES |
YES |
NO |
YES |
Total number of vaccinated animals, by species, (in each vaccination zone, where applicable) |
YES |
YES |
NO |
YES |
Total number of doses administered or distributed |
YES |
YES |
YES |
YES |
Expected date for completing the vaccination |
NO |
YES |
YES |
YES |
Total number of vaccinated animals killed. |
YES |
WHERE APPLICABLE |
NO |
NO |
Dates of killing of the vaccinated animals (suppressive vaccination) or expected date of completion of killing (protective vaccination, where applicable) |
YES |
WHERE APPLICABLE |
NO |
NO |
2.
Time points and minimum frequency to submit the reports
Emergency vaccination strategy |
Preventive vaccination |
||
Suppressive vaccination |
Protective vaccination |
In wild animals |
|
Within 7 days from the end of the administration of the vaccine to all animals included in the official vaccination plan |
At least once every two weeks for the first month of vaccination and once a month for the rest of the duration of the vaccination for one-year or shorter vaccination campaigns |
At least once a month for one-year or shorter vaccination campaigns |
Once a year |
At least once at the end of the annual vaccination for multi-year vaccination campaigns |
At least every 6 months for multi-year vaccination campaigns |
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
Recovery period |
Type of surveillance to demonstrate the absence of occurrence of FMD |
3 months after the last remaining vaccinated animal in the vaccination zone has been killed or slaughtered, excluding animals referred to in Article 13(2) of Regulation (EU) 2020/687 |
Clinical and laboratory |
The relevant recommendations in the FMD Chapter, 30th edition 2022, of the WOAH Terrestrial Animal Health Code are met |
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
Recovery period |
Type of surveillance to demonstrate the absence of occurrence of LSD |
14 months after the slaughter or killing of the last case, or after the last vaccination if emergency protective vaccination has been used (in vaccination zone II), whichever occurred last, and during which period clinical and laboratory surveillance has demonstrated no occurrence of LSD |
Clinical and laboratory (virological and serological) |
26 months after the slaughter or killing of the last case, or after the last vaccination if emergency protective vaccination has been used (in vaccination zone II), whichever occurred last, and during which period clinical surveillance alone has demonstrated no occurrence of LSD |
Clinical |
8 months after the last vaccination if emergency protective vaccination has been used (in vaccination zone I), and during which period clinical and laboratory surveillance has demonstrated no occurrence of LSD |
Clinical and laboratory (virological and serological) |
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
Recovery period |
Type of surveillance to demonstrate the absence of occurrence of PPR |
6 months after the slaughter or killing of the last case and of all vaccinated animals if emergency protective vaccination has been used, and during which period clinical and laboratory surveillance has demonstrated no occurrence of PPR |
Clinical and laboratory (virological and serological) |
24 months after the slaughter or killing of the last case, or after the last vaccination if emergency protective vaccination has been used, whichever occurred last, and during which period clinical and laboratory surveillance has demonstrated no occurrence of PPR |
Clinical and laboratory (virological and serological) |
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
Recovery period |
Type of surveillance to be implemented during the recovery period |
12 months, since the last animal was vaccinated and 2 years since the last outbreak |
Clinical and serological |
The relevant recommendations in the AHS Chapter, 30th edition 2022, of the WOAH Terrestrial Animal Health Code |
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
Recovery period |
Type of surveillance to be implemented during the recovery period |
3 months after all vaccinated porcine animals have been slaughtered or killed, excluding kept porcine animals referred to in Article 13(2) of Regulation (EU) 2020/687 when there are means, validated in accordance with the Terrestrial Manual of the WOAH, of distinguishing between vaccinated and infected kept porcine animals. |
Clinical and serological |
The relevant recommendations in the CSF Chapter, 30th edition 2022, of the WOAH Terrestrial Animal Health Code |
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
Recovery period |
Type of surveillance to be implemented during the recovery period |
28 days after completion of the emergency protective vaccination or at the time of the lifting of the restricted zones established in accordance with Article 21 of Delegated Regulation (EU) 2020/687 if this comes later. |
Reinforced surveillance in accordance with Article 9(1), point (c) and Part 2. |
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
Recovery period |
Type of surveillance to be implemented during the recovery period |
3 months after completion of the emergency protective vaccination or at the time of the lifting of the restricted zones established in accordance with Article 21 of Delegated Regulation (EU) 2020/687 if this comes later. |
The reinforced surveillance in accordance with Article 9(1), point (c) |