Nařízení Komise v přenesené pravomoci (EU) 2026/1073 ze dne 6. března 2026, kterým se mění a opravuje nařízení v přenesené pravomoci (EU) 2023/361, kterým se doplňuje nařízení Evropského parlamentu a Rady (EU) 2016/429, pokud jde o pravidla pro používání určitých veterinárních léčivých přípravků pro prevenci a tlumení některých nákaz uvedených na seznamu

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 , ELI: http://data.europa.eu/eli/reg/2016/429/oj. , and in particular Article 47(1)(b) and (c) thereof,

OJ L 84, 31.3.2016, p. 1 , ELI: http://data.europa.eu/eli/reg/2016/429/oj.

(1) Commission Delegated Regulation (EU) 2023/361Commission Delegated Regulation (EU) 2023/361 of 28 November 2022 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules on the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases (OJ L 52, 20.2.2023, p. 1 , ELI: http://data.europa.eu/eli/reg_del/2023/361/oj). supplements Regulation (EU) 2016/429 as regards rules on the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases. It provides among others for detailed and specific rules on the use in the Union of veterinary medicinal products with regard to prevention and control of the listed diseases referred to in Article 9(1)(a) (category A diseases) of Regulation (EU) 2016/429 in kept and wild terrestrial animals.

(2) Article 2 of Delegated Regulation (EU) 2023/361 set out definitions of terms used in that Regulation, including that of recovery period. After the completion of emergency protective vaccination an exit strategy should enable Member States to demonstrate the absence of infection before the restrictions to movements of animals and their products may be lifted. Such an exit strategy should consist of a specific reinforced clinical and laboratory surveillance during a pre-defined waiting period for each specific category A disease. There is no free status for category A diseases in EU rules, so the term recovery period, which refers to the recovery of a free status, should be replaced by waiting period. The definition thereof should be updated and Article 2 amended accordingly, as well as the title and point (1) of Article 16.

(3) Moreover, the relevant disease-specific Annexes should describe in their Parts 4 respective conditions for this waiting period and not refer to animal health status, including status granted by WOAH. Therefore, all the disease-specific annexes should be amended accordingly to include this conceptual change.

(4) Article 4 of Delegated Regulation (EU) 2023/361 lists the veterinary medicinal products prohibited for the prevention and control of category A and B diseases. Part 3 of Annex I lists the diseases for which some specific type of veterinary medicinal products allowed, and the conditions for their use; both the type and the use should comply with this Part 3 of Annex I, and it should be clearly stated in Article 4.

(5) Article 7 of Delegated Regulation (EU) 2023/361 sets up vaccination strategies for prevention and control of Category A diseases and distinguishes between emergency and preventive vaccination strategies. Return of experience from vaccination plans applied in the field show that emergency protective vaccination may be applied when outbreaks of a listed disease occur in zones where preventive vaccination against that disease is already implemented. In order to avoid misunderstanding, implementation of emergency protective vaccination should be

(6) During the review of Delegated Regulation (EU) 2023/361, Article 13 was considered unclear and should be amended for clarity: paragraphs 1 to 4 should not lay down in the detail which animals or products are prohibited and may be moved, and should clearly refer to the relevant parts of the annexes for the details, and paragraph 6 should be clarified to explain better the restrictions in accordance with paragraphs 1 to 5 of that Article, which apply simultaneously with the restricted zones in accordance with Commission Delegated Regulation (EU) 2020/687Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, p. 64 , ELI: http://data.europa.eu/eli/reg_del/2020/687/oj). .

(7) During the review of Delegated Regulation (EU) 2023/361, it was noted that for clarity, Article 14(2)(a) should include a reference to the Article 13(1) that lists the animals and products subject to prohibition.

(8) Delegated Regulation (EU) 2023/361 lays down specific conditions, in the respective disease-specific annexes, for each category A disease based on the experience and data that were available at the time of its adoption. For diseases for which sufficient experience and data were not available at the time of its adoption, disease specific measures could not be provided.

(9) For Foot-and-Mouth Disease (FMD), recent outbreaks provided information relevant to the difficulties to use protective vaccination and the necessity to clarify in annex VII that all animals of listed species were concerned by prohibition, how surveillance was to be implemented and according which conditions derogations to prohibition could be granted.

(10) For Lumpy Skin Disease (LSD), recent field experience and scientific data provided further information and evidence that should be taken into account in annex IX for the conditions related to the vaccination zones, and the related restrictions and waiting period before their lifting.

(11) For Classical Swine Fever (CSF), up-to-date available scientific data should be used to update the conditions for vaccination of domestic pigs in annex XII and lay down specific conditions for vaccination of wild pigs in a new annex.

(12) For Highly Pathogenic Avian Influenza (HPAI), recent experience of field implementation of vaccination of poultry, as well as scientific data on vaccination, risk-mitigation and surveillance, including a European Food Safety Authority (EFSA) scientific opinion, provided sufficient information to amend and update the specific conditions in annex XIII for restrictions, derogations, and surveillance, notably when preventive vaccination in applied.

(13) For African Swine Fever (ASF), although currently no effective and safe vaccine is available, in view of recent EFSA reports and updated scientific data on vaccines included in the WOAH Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, new annexes should be added to describe the conditions for use of such vaccines, once available, respectively in domestic and in wild pigs.

(14) For Sheep Pox and Goat Pox (SPGP), the scientific justifications for the modification of the relevant chapters of the WOAH Terrestrial Animal Health Code have provided sufficient data to lay down specific conditions in a new annex.

(15) For consistency between the articles and the Annexes, the numbering should be amended due to additions or deletions of points, and to the addition of new Annexes.

(16) Finally, editorial errors in Article 3(2) should be corrected,

Delegated Regulation (EU) 2023/361 is corrected as follows:

In Article 3, paragraph 2 is replaced by the following: 2.The conditions for the use of vaccines against category A diseases shall not apply to certain uses of vaccines against infection with Newcastle disease virus, notably to routine precautionary use or to use in the framework of trade, which the Member States may allow irrespectively of the official disease prevention and control measures referred to in paragraph 1, for purposes other than responding to an outbreak.

The conditions for the use of vaccines against category A diseases shall not apply to certain uses of vaccines against infection with Newcastle disease virus, notably to routine precautionary use or to use in the framework of trade, which the Member States may allow irrespectively of the official disease prevention and control measures referred to in paragraph 1, for purposes other than responding to an outbreak.

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 on the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases (OJ L 52, 20.2.2023, p. 1 , ELI: http://data.europa.eu/eli/reg_del/2023/361/oj).

Article 2 Article 2 Correction

Article 3 Article 3 Entry into force

Article 13 Article 13 Risk-mitigating measures in the vaccination zone when implementing emergency protective vaccination and emergency vaccination in wild animals 1.When implementing emergency protective vaccination the competent authority shall prohibit: (a) the movements of animals and products thereof laid down in Part 3, point 1, of Annexes VII to XVIII;(b) the collection of germinal products from animals laid down in Part 3, point 2, of Annexes VII to XVIII;(c) in the absence of disease-specific conditions laid down in Part 3, of Annexes VII to XVIII, movements of:(i) vaccinated animals from the establishment where they were vaccinated;(ii) products from vaccinated animals from the production and/or processing establishments. 2.By way of derogation from paragraph 1, point (a), the competent authority may allow movements of animals, either: (a) if they are subject to compulsory killing after vaccination, in accordance with the official vaccination plan referred to in Article 5(1), point (b), and they are moved to be killed at the nearest suitable place;or (b) if they are not subject to compulsory killing after vaccination, in accordance with the official vaccination plan referred to in Article 5(1), point (b), and they comply with the conditions laid down in Part 3, point 3, of Annexes VII to XVIII. 3.By way of derogation from paragraph 1, point (a), the competent authority may allow movements of products of animals from the production and/or processing establishment in accordance with the conditions laid down in Part 3, point 3, of Annexes VII to XVIII. 4.By way of derogation from paragraph 1, point (b), the competent authority may allow the collection of germinal products in accordance with the conditions laid down in Part 3, point (3), of Annexes VII to XVIII. 5.When implementing emergency vaccination in wild animals the competent authority shall apply in the vaccination zone the disease-specific restrictions and other risk-mitigating measures set out in Part 3 of Annexes VII to XVIII for the relevant disease, where provided specifically for emergency vaccination in wild animals. 6.In vaccination zones situated in a restricted zone in accordance with Delegated Regulation (EU) 2020/687, the restrictions and other risk-mitigating measures provided for in paragraphs 1 and 5 shall apply in addition to the measures applicable to: (a) protection and surveillance zones and further restricted zones where applicable, established in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687 in the event of an outbreak of a category A disease in kept terrestrial animals, until they are lifted in accordance with Articles 39 and 55 of that Regulation;(b) infected zones established in accordance with Article 63(1) of Delegated Regulation (EU) 2020/687 in the event of an outbreak of a category A disease in wild animals, until they are lifted in accordance with Article 67 of that Regulation;(c) restricted zones established under emergency measures provided for in Articles 71, 257 and 258 of Regulation (EU) 2016/429, and any rules adopted pursuant to Article 71(3) and Article 259 of that Regulation until those measures are lifted. 7.The measures referred to in paragraphs 1 and 5 shall continue to apply after the measures referred to in paragraph 6 have been lifted.

This Regulation shall enter into force 20 days following that of its publication in the Official Journal of the European Union .

Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, p. 64 , ELI: http://data.europa.eu/eli/reg_del/2020/687/oj).

When implementing emergency protective vaccination the competent authority shall prohibit:

(a) the movements of animals and products thereof laid down in Part 3, point 1, of Annexes VII to XVIII;

(b) the collection of germinal products from animals laid down in Part 3, point 2, of Annexes VII to XVIII;

(c) in the absence of disease-specific conditions laid down in Part 3, of Annexes VII to XVIII, movements of:(i) vaccinated animals from the establishment where they were vaccinated;(ii) products from vaccinated animals from the production and/or processing establishments.

(i) vaccinated animals from the establishment where they were vaccinated;

(ii) products from vaccinated animals from the production and/or processing establishments.

By way of derogation from paragraph 1, point (a), the competent authority may allow movements of animals, either:

(a) if they are subject to compulsory killing after vaccination, in accordance with the official vaccination plan referred to in Article 5(1), point (b), and they are moved to be killed at the nearest suitable place;or

(b) if they are not subject to compulsory killing after vaccination, in accordance with the official vaccination plan referred to in Article 5(1), point (b), and they comply with the conditions laid down in Part 3, point 3, of Annexes VII to XVIII.

By way of derogation from paragraph 1, point (a), the competent authority may allow movements of products of animals from the production and/or processing establishment in accordance with the conditions laid down in Part 3, point 3, of Annexes VII to XVIII.

By way of derogation from paragraph 1, point (b), the competent authority may allow the collection of germinal products in accordance with the conditions laid down in Part 3, point (3), of Annexes VII to XVIII.

When implementing emergency vaccination in wild animals the competent authority shall apply in the vaccination zone the disease-specific restrictions and other risk-mitigating measures set out in Part 3 of Annexes VII to XVIII for the relevant disease, where provided specifically for emergency vaccination in wild animals.

In vaccination zones situated in a restricted zone in accordance with Delegated Regulation (EU) 2020/687, the restrictions and other risk-mitigating measures provided for in paragraphs 1 and 5 shall apply in addition to the measures applicable to:

(a) protection and surveillance zones and further restricted zones where applicable, established in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687 in the event of an outbreak of a category A disease in kept terrestrial animals, until they are lifted in accordance with Articles 39 and 55 of that Regulation;

(b) infected zones established in accordance with Article 63(1) of Delegated Regulation (EU) 2020/687 in the event of an outbreak of a category A disease in wild animals, until they are lifted in accordance with Article 67 of that Regulation;

(c) restricted zones established under emergency measures provided for in Articles 71, 257 and 258 of Regulation (EU) 2016/429, and any rules adopted pursuant to Article 71(3) and Article 259 of that Regulation until those measures are lifted.

The measures referred to in paragraphs 1 and 5 shall continue to apply after the measures referred to in paragraph 6 have been lifted.

HAS ADOPTED THIS REGULATION: