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)

1 This Regulation supplements the rules laid down in Regulation (EU) 2016/429 on the use within the Union of veterinary medicinal products with regard to prevention and control of the listed diseases referred to in Article 9(1), points (a) and (b), of Regulation (EU) 2016/429 in kept and wild terrestrial and aquatic animals (‘animals’). In particular, it lays down: (a) prohibitions and restrictions on the use of certain veterinary medicinal products in animals for prevention and control of category A and B diseases; (b) rules on the use of vaccines in animals for prevention and control of category A and certain category B diseases; (c) risk-mitigating measures to prevent the spread of category A diseases through vaccinated animals or products from such animals; (d) rules on surveillance of category A diseases following the use of vaccines in terrestrial animals for their prevention and control.

2 This Regulation does not apply to the use of the veterinary medicinal products referred to in paragraph 1 for scientific studies or for the purposes of developing and testing them, as referred to in Article 46(3) of Regulation (EU) 2016/429.

1 For the purposes of this Regulation the following definitions apply: (a) ‘category A disease’ means a listed disease that does not normally occur in the Union and for which immediate eradication measures must be taken as soon as it is detected, as referred to in Article 9(1), point (a), of Regulation (EU) 2016/429; (b) ‘category B disease’ means a listed disease which must be controlled in all Member States with the goal of eradicating it throughout the Union, as referred to in Article 9(1), point (b), of Regulation (EU) 2016/429; (c) ‘emergency suppressive vaccination’ means a vaccination strategy implemented by the competent authority in kept terrestrial animals for the prevention and control of category A diseases in accordance with Article 7(1), point (a)(i); (d) ‘emergency protective vaccination’ means a vaccination strategy implemented by the competent authority in kept terrestrial animals for the prevention and control of category A diseases in accordance with Article 7(1), point (a)(ii); (e) ‘emergency vaccination in wild terrestrial animals’ means a vaccination strategy implemented by the competent authority in wild terrestrial animals for the prevention and control of category A diseases in accordance with Article 7(1), point (a)(iii); (f) ‘preventive vaccination’ means a vaccination strategy implemented by the competent authority for the prevention and control of category A diseases in accordance with Article 7(1), point (b); (g) ‘vaccination zone’ means a zone in which a vaccine is administered to listed species to prevent and control category A diseases; (h) ‘peri-vaccination zone’ means a zone, surrounding the vaccination zone, where vaccination for the purpose of preventing and controlling category A diseases is not allowed and where reinforced surveillance is implemented to detect those diseases. (i) ‘confirmed outbreak’ means an outbreak confirmed in accordance with Article 9(2), (3) and (4) of Delegated Regulation (EU) 2020/689; (j) ‘recovery period’ means the necessary period of time required for a vaccination zone to recover the animal health status prior to the implementation of vaccination against a category A disease, by demonstrating absence of the category A disease after emergency protective vaccination against the disease has been carried out; (k) ‘protection zone’ means a protection zone as established on the basis of Article 21(1), point (a), of Delegated Regulation (EU) 2020/687; (l) ‘surveillance zone’ means a surveillance zone as established on the basis of Article 21(1), point (b), of Delegated Regulation (EU) 2020/687; (m) ‘bovine animal’ means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring of crossings of those species; (n) ‘ovine animal’ means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species; (o) ‘caprine animal’ means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species; (p) ‘camelid animal’ means an animal of the species of ungulates belonging to the family Camelidae listed in Annex III to Regulation (EU) 2016/429; (q) ‘porcine animal’ means an animal of the species of ungulates belonging to the family Suidae listed in Annex III to Regulation (EU) 2016/429; (r) ‘equine animal’ as an animal of species of solipeds belonging to the genus Equus (including horses, asses, and zebras) and the offspring of crossings of those species; (s) ‘day-old chicks’ means all poultry less than 72 hours old.

2 In addition to the definitions laid down in paragraph 1, the definitions of ‘veterinary medicinal product’, ‘immunological veterinary medicinal product’ and ‘antimicrobial’ set out in Article 4(1), (5) and (12) of Regulation (EU) 2019/6 shall apply.

1 Member States may allow the use of vaccines in animals for the prevention and control of category A diseases, except for the diseases listed in Part 1 of Annex I, only under the control of the competent authority and if they are used: (a) as a part of the official measures put in place by the competent authority for prevention and control of those diseases; (b) under the conditions laid down in this Regulation.

2 The conditions for the use of vaccines against category A diseases, laid down in the first subparagraph, 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, that the Member States may allow outside the official disease prevention and control measures referred to in paragraph 1 for purposes other than responding to an outbreak.

3 Member States may allow the use of vaccines in animals for prevention and control of category B diseases, except for the diseases listed in Part 2 of Annex I, in those listed species for which the corresponding diseases have been classified as category B.

Member States shall prohibit the use of the following veterinary medicinal products in animals for the prevention and control of category A and B diseases unless they are used for the prevention and control of the diseases listed in Part 3 of Annex I and their use complies with the conditions set out therein: (a) immunological veterinary medicinal products to diagnose the state of immunity of animals; (b) hyper-immune serum; (c) inactivated immunological veterinary medicinal products, as referred to in Article 2(3) of Regulation (EU) 2019/6; (d) antimicrobials.

1 The competent authority may decide on the use of vaccines in animals to prevent and control category A diseases, in accordance with Article 3(1), provided that: (a) it has carried out an assessment to support this decision considering at least the criteria set out in Part 1 of Annex II, in addition to the criteria provided for in Article 46(2) of Regulation (EU) 2016/429; (b) the vaccines are used in accordance with an official vaccination plan which fulfils the requirements laid down in Article 6.

2 The competent authority may carry out the assessment referred to in paragraph 1, point (a), following the simplified rules provided for in Part 2 of Annex II when implementing the vaccination strategy referred to in Article 7(1), point (a)(i).

1 The official vaccination plan referred to in Article 5(1), point (b), shall: (a) detail, at least, the information and measures set out in Part 1 of Annex III; (b) be implemented under the control of the competent authority and only for the strictly necessary period of time.

2 The competent authority may include in the official vaccination plan referred to in Article 5(1), point (b), the simplified information provided for in Part 2 of Annex III, when implementing the vaccination strategy referred to in Article 7(1), point (a)(i).

3 The competent authority shall keep up to date, amend or supplement the official vaccination plan referred to in Article 5(1), point (b), taking into account the evolution of its implementation and the evolution of the epidemiological situation of the disease.

4 Member States shall provide the other Member States and the Commission with: (a) at least the preliminary information set out in Annex IV, at the latest two days before starting the vaccination; (b) the official vaccination plan and its amendments and updates, as soon as possible and at the latest two weeks after starting the vaccination or implementing the amendments or updates of the official vaccination plan.

5 The Commission shall, in accordance with Article 71 of Regulation (EU) 2016/429, review the national measures referred to in paragraph 2 of that Article, as laid in the official vaccination plan, and act in accordance with that Article.

1 The competent authority may implement the following vaccination strategies to prevent and control category A diseases in terrestrial animals, in accordance with Article 3(1): (a) emergency vaccination, as referred to in Article 69 of Regulation (EU) 2016/429, may be any of the following: (i) emergency suppressive vaccination, implemented in response to an outbreak of a category A disease to control its spread and limited to kept terrestrial animals that are to be killed in accordance with Articles 12(1), point (a), and 18(1), point (b), of Delegated Regulation (EU) 2020/687 but are subject to the derogation provided for in Article 12(4), point (b), of that Regulation; (ii) emergency protective vaccination, implemented in response to an outbreak of a category A disease, which is carried out in any of the following cases: on terrestrial animals at risk of infection that are kept in establishments located in affected Member States or zones thereof, in which category A diseases have not been confirmed nor are suspected in accordance with Article 6(1) and Article 11 of Delegated Regulation (EU) 2020/687, in response to a change in the risk of introduction of a category A disease in a non-affected Member State or zone thereof, on affected equine animals subject to the derogation provided for in point 1 of Annex III to Delegated Regulation (EU) 2020/687; (iii) emergency vaccination in wild terrestrial animals, implemented in response to an outbreak of a category A disease; (b) preventive vaccination, where a vaccine against a category A disease is administered to terrestrial animals in non-affected geographic areas for preventive purposes other than the cases covered by emergency protective vaccination.

2 The competent authority may implement the strategies referred to in paragraph 1 simultaneously or consecutively in different kept and wild terrestrial animal populations, in different geographic zones and at different time points throughout an outbreak, and may vary the strategies applied according to the zone, species affected or other defining characteristics. In such cases, the competent authority shall include all the strategies applied simultaneously or consecutively in the official vaccination plan after the assessment referred to in Article 5(1), point (a).

When implementing emergency suppressive vaccination, as referred to in Article 7(1), point (a)(i), the competent authority shall: (a) vaccinate the animals subject to the derogation provided for in Article 12(4), point (b), of Delegated Regulation (EU) 2020/687 without delay after the confirmation of the relevant outbreak(s); (b) order and supervise the killing of all vaccinated animals as soon as possible, in accordance with the rules laid down in either Article 12(1), point (a), or Article 12(4), point (a), of Delegated Regulation (EU) 2020/687 and under the biosecurity measures provided for in Articles 12(1), point (c), and Article 12(2) of that Delegated Regulation.

1 When implementing emergency protective vaccination, as referred to in Article 7(1), point (a)(ii), and emergency vaccination in wild animals, as referred to in Article 7(1), point (a)(iii), the competent authority shall: (a) specify the type of vaccine to be used or prioritised, the minimum vaccine coverage and the targeted animals/species; (b) establish geographically: (i) a vaccination zone, in which vaccination is carried out, in order to prevent spreading of the category A disease from affected areas to non-affected areas; (ii) a peri-vaccination zone, surrounding the vaccination zone, in which vaccination is not allowed, covering a distance width from the perimeters of the vaccination zone; (c) implement reinforced clinical and laboratory surveillance in the vaccination and peri-vaccination zones referred to in point (b): (i) to assess vaccination effectiveness in the vaccination zone; (ii) to detect any possible new outbreak of the disease in the vaccination and peri-vaccination zones; (iii) in accordance with Annex I to Delegated Regulation (EU) 2020/687 as regards the sampling procedures, diagnostic methods and transport of samples; (iv) selecting the diagnostic methods depending on the type of vaccine administered.

2 By way of derogation from paragraph 1, point (b)(ii), the competent authority may decide not to establish the peri-vaccination zone when implementing emergency protective vaccination in zones where the relevant category A disease has not been suspected or confirmed and when implementing emergency vaccination in wild animals.

3 Where vaccination zones or peri-vaccination zones as provided for in paragraph 1, point (b), are situated in the territory of more than one Member State, the competent authorities of those Member States shall cooperate in establishing them.

4 Where disease-specific conditions are laid down in Parts 1 and 2 of Annexes VII to XIV, the competent authority shall implement the measures laid down in paragraph 1 in accordance with those conditions.

1 Preventive vaccination may only be implemented for the prevention of category A diseases for which specific conditions for preventive vaccination are laid down in Part 5 of Annexes VII to XIV, and shall be implemented in accordance with those conditions.

2 When implementing preventive vaccination, as referred to in Article 7(1), point (b), the competent authority shall: (a) specify the type of vaccine to be used or prioritised; (b) implement reinforced clinical and laboratory surveillance; in accordance with the relevant disease-specific conditions laid down in Part 5 of Annexes VII to XIV, where provided.

1 When implementing emergency and preventive vaccination the competent authority shall ensure that at least the information detailed in Annex V on the vaccination is recorded.

2 The competent authority shall provide the other Member States and the Commission with a report on the implementation of the vaccination that includes at least the relevant information detailed in point 1 of Annex VI at the time points and minimum frequency provided for in point 2 of that Annex.

1 When implementing emergency or preventive vaccination the competent authority shall ensure that the following tasks are under the supervision of an official veterinarian: (a) distribution and administration of the vaccine; (b) returning of any residual quantities of the vaccine to the point of distribution or to any other designated point with a record on the vaccinated establishments, the number of vaccinated animals and the number of doses used.

2 During the administration of the vaccine and the return of residual quantities of the product, the competent authority shall put in place all the necessary measures to avoid the possible spread of disease agents.

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 XIV; (b) the collection of the following germinal products from animals of listed species, laid down in Part 3, point 2, of Annexes VII to XIV: (i) semen; (ii) oocytes; (iii) embryos; (c) in the absence of disease-specific conditions laid down in Part 3, of Annexes VII to XIV, 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 vaccinated animals from the establishment where they were vaccinated if: (a) 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) 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 are either: (i) not subject to prohibitions of movements; or (ii) they are subject to prohibitions of movements but they comply with the relevant conditions and the competent authority has authorised their movement in accordance with the conditions laid down in Part 3, point 3, of Annexes VII to XIV.

3 By way of derogation from paragraph 1, point (a), the competent authority may allow movements of products from vaccinated animals from the production and/or processing establishment if: (a) they are not subject to prohibitions of movements; or (b) the competent authority has authorised their movement in accordance with the conditions laid down in Part 3, point 3, of Annexes VII to XIV.

4 By way of derogation from paragraph 1, point (b), the competent authority may allow the collection of the germinal products listed therein if: (a) they are not subject to prohibition of collection; or (b) the competent authority has authorised their collection in accordance with the conditions laid down in Part 3, point (3), of Annexes VII to XIV.

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 XIV for the relevant disease, where provided specifically for emergency vaccination in wild animals.

6 The restrictions and other risk-mitigating measures provided for in paragraphs 1 and 5 shall apply in the vaccination zones 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.

1 When implementing preventive vaccination the competent authority shall prohibit the movement of vaccinated animals from the establishment where they were vaccinated and the movement of products from vaccinated animals from the production and/or processing establishment.

2 By way of derogation from paragraph 1, the competent authority may allow movements of vaccinated animals and products thereof from the establishment where they were vaccinated or where they were produced and/or processed if: (a) they are not included in the list of animals and products subject to prohibitions of movements; (b) they are subject to prohibitions of movements but they comply with the relevant conditions and the competent authority has authorised their movement; in accordance with the conditions laid down in Part 5 of Annexes VII to XIV, where provided.

Operators shall move animals and products, to which measures provided for in Article 13(1) apply, within a Member State or from one Member State to another Member State, only if the animals and products to be moved comply with the relevant conditions provided for in Article 13 and are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with: (a) Article 149(1) of Regulation (EU) 2016/429 for kept terrestrial animals; (b) Article 161(4) of Regulation (EU) 2016/429 for germinal products; (c) Article 167(3) of Regulation (EU) 2016/429 for products of animal origin; (d) Article 22(5) and (6) of Delegated Regulation (EU) 2020/687 for animal by-products;

1 After the completion of emergency protective vaccination the competent authority shall respect the relevant disease-specific recovery periods provided for in Part 4 of Annexes VII to XIV, during which clinical and/or laboratory surveillance demonstrating the absence of infection with the relevant pathogen is conducted in the vaccination and peri-vaccination zones.

2 The surveillance referred to in paragraph 1 shall be implemented: (a) in accordance with: (i) the disease-specific conditions set out in Part 4 of Annexes VII to XIV; (ii) Annex I to Delegated Regulation (EU) 2020/687, as regards the sampling procedures, diagnostic methods and transport of samples; (b) taking into account the type of vaccine administered.

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