BAKGRUNN (fra kommisjonsforordningen)

(1) Regulation (EU) 2019/6 lays down rules for use of veterinary medicinal products, including the requirement to use them in accordance with the terms of their marketing authorisations. Where there is no veterinary medicinal product authorised or available in a Member State for a species or for an indication, veterinarians may, in particular to avoid causing unacceptable suffering, under their direct responsibility use medicinal products outside the terms of their marketing authorisations in accordance with the rules laid down in Articles 112, 113 or 114 of that Regulation, as applicable to the animal species concerned.

(2) Article 107(6), first subparagraph, of Regulation (EU) 2019/6 provides for the possibility to establish, by means of implementing acts, and taking into consideration scientific advice of the European Medicines Agency (the ‘Agency’), lists prohibiting the use of certain antimicrobials in accordance with Articles 112, 113 and 114 of that Regulation or restricting the use of certain antimicrobials in accordance with Articles 112, 113 and 114 of that Regulation only subject to certain conditions.

(3) Article 114(3) of Regulation (EU) 2019/6 provides for the establishment, by means of implementing acts, of a list of substances used in veterinary medicinal products authorised in the Union for use in food-producing terrestrial animal species or substances contained in a medicinal product for human use authorised in the Union in accordance with Directive 2001/83/EC of the European Parliament and of the Council (2) or Regulation (EC) No 726/2004 of the European Parliament and of the Council (3), which may be used in food-producing aquatic species in accordance with Article 114(1) of Regulation (EU) 2019/6.

(4) Article 115(5) of Regulation (EU) 2019/6 provides for the establishment, by means of implementing acts, of a list of substances which are essential for the treatment of equine species, or which bring added clinical benefit compared to other treatment options available for equine species and for which the withdrawal period for equine species shall be six months.

(5) In order to ensure legal certainty for the competent authorities, veterinarians, animal keepers and economic operators concerned, as well as coherence between the provisions of this Regulation and the implementing acts to be adopted under Articles 114(3) and 115(5) of Regulation (EU) 2019/6, food-producing aquatic species and equine species should be excluded from the scope of this Regulation.

(6) On the basis of the criteria laid down in Article 107(6), second subparagraph, of Regulation (EU) 2019/6, the Agency evaluated antimicrobials and groups of antimicrobials that have potential veterinary use in the Union (4), taking into consideration the latest available scientific evidence, Regulation (EC) No 470/2009 of the European Parliament and of the Council (5) and Commission Regulation (EU) No 37/2010 (6). The Agency also considered information collected from an ‘open call for data’ (7) in which interested parties were invited to submit information on the uses and availability of antimicrobials in the Union to treat serious infections in animals, including uses outside the terms of a marketing authorisation, and used as reference various categorisations of antimicrobials developed by international organisations or by the Agency.

(7) The antimicrobials and groups of antimicrobials included in the Annex to Commission Implementing Regulation (EU) 2022/1255 (8) are prohibited for any use in animals, including uses in accordance with Articles 112 and 113 of Regulation (EU) 2019/6. Therefore, the Agency did not evaluate those antimicrobials.

(8) The Agency examined the various cases of use in accordance with Articles 112 and 113 of Regulation (EU) 2019/6. This included use for indications, animal species or via routes of administration not included in the terms of the marketing authorisation of veterinary medicinal products, use of medicinal products for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004, use of veterinary medicinal products prepared extemporaneously in accordance with the terms of a veterinary prescription and use of veterinary medicinal products authorised in a third country for the same animal species and same indication.

(9) The Agency considered that the use of some antimicrobials in accordance with Articles 112 and 113 of Regulation (EU) 2019/6 in the cases where therapeutic needs require that a medicinal product be used via routes of administration not included in the terms of its marketing authorisation could significantly increase the antimicrobial resistance risks. To help mitigate those risks a condition was proposed to restrict the use of those antimicrobials to individual animals only.

(10) In accordance with Article 113(4) of Regulation (EU) 2019/6, only active substances allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof can be used for the purposes of that Article. The conditions imposed by this Regulation should therefore be without prejudice to that provision.

(11) Taking into consideration the Agency’s advice, the use of certain antimicrobials in accordance with Articles 112 and 113 of Regulation (EU) 2019/6 should be subject to certain conditions, including, in certain instances, a ban to use them in specific species.

(12) Regulation (EU) 2016/429 of the European Parliament and of the Council (9) provides for the possibility to impose prohibitions and restrictions on the use of veterinary medicinal products for the prevention and control of certain diseases. Under Regulation (EC) No 2160/2003 of the European Parliament and of the Council (10), the use of veterinary medicinal products may be prohibited as part of national control programmes. In addition, Article 107(7) of Regulation (EU) 2019/6 allows Member States to adopt measures further restricting or prohibiting the use of antimicrobials in animals on their respective territories if the administration of such antimicrobials to animals is contrary to the implementation of a national policy on prudent use of antimicrobials. This Regulation should therefore apply without prejudice to any such national measures and to the provisions laid down in those Regulations or any acts adopted on the basis thereof.

(13) In its scientific advice, the Agency recommended that the use of certain antimicrobials in accordance with Articles 112 and 113 of Regulation (EU) 2019/6 should be based on the results of prior target pathogen identification and antimicrobial susceptibility testing demonstrating that the antimicrobial concerned is likely to be effective and that preferable antimicrobials in accordance with the Categorisation of antibiotics in the European Union of the European Medicines Agency (11) would not be effective. However, it is not always possible in practice for the veterinarian to base the choice of an antimicrobial for use in accordance with those articles on such identification and susceptibility testing. In these cases, the veterinarian responsible should be able to demonstrate why the use of a certain antimicrobial could not be based on such identification and susceptibility testing. In cases where the animals’ condition necessitates that the veterinarian starts using the antimicrobial concerned without delay, the veterinarians responsible should be allowed to start using the antimicrobial concerned before the results of target pathogen identification or antimicrobial susceptibility testing are known. To ensure prudent use of antimicrobials, the choice of antimicrobial should be adapted, if needed, after the results of such identification and susceptibility testing become available.

(14) Where an antimicrobial is already authorised for use in cattle, sheep for meat production, pigs, chickens, dogs or cats, the extent of the additional exposure to that antimicrobial due to use in other animals is likely to be relatively small. In addition, there are fewer antimicrobial veterinary medicinal products authorised for use in sheep, including sheep for meat production. Therefore, in order to not disadvantage the sectors of those animals, for which there are less available antimicrobials and to ensure availability of antimicrobials for and to maintain the welfare of animals other than cattle, pigs, chickens, dogs or cats, the condition for target pathogen identification and antimicrobial susceptibility testing should not be imposed on the use in accordance with Articles 112 or 113 of Regulation (EU) 2019/6 in those animals, where the antimicrobial concerned is contained in a veterinary medicinal product authorised in the Union for use in cattle, sheep for meat production, pigs, chickens, dogs or cats.

(15) In order to allow competent authorities, veterinarians, animal keepers and economic operators concerned the necessary time to adapt to the requirements of this Regulation, its application should be deferred.

(16) The list of antimicrobials and related restrictions laid down in this Regulation should be kept under continual review in the light of new scientific evidence or emerging information, including the emergence of new diseases, changes in the epidemiology of existing diseases, changes in antimicrobial resistance or changes in availability or patterns of antimicrobial use, as well as the marketing authorisation of new veterinary medicinal products or medicinal products for human use.

(17) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,