(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 food-producing animals of the equine species or for an indication, veterinarians may, in particular to avoid causing unacceptable suffering and under their direct responsibility, use medicinal products outside the terms of their marketing authorisations, in accordance with the rules laid down in Articles 113 and 115 of that Regulation. 

(2) In order to increase the availability of medicinal products to food-producing animals of the equine species while ensuring a high level of consumer protection, and by way of derogation from Article 113(1) and (4) of Regulation (EU) 2019/6, 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. 

(3) Commission Regulation (EC) No 1950/2006, as amended by Commission Regulation (EU) No 122/2013, had established a list of substances essential for the treatment of equidae and of substances bringing added clinical benefit. 

(4) The Annex to Commission Regulation (EC) No 1950/2006 was last updated in 2013 by means of Commission Regulation (EU) No 122/2013. Therefore, the experience gained from using the substances listed in that Annex should serve as basis for establishing the list referred to in Article 115(5) of Regulation (EU) 2019/6, including the need to update the information on use of those substances, their advantages and alternatives. Furthermore, the need to add other substances as a result of newly available evidence should also be considered. 

(5) To ensure a high level of consumer protection, substances should only be included in the list set out in this Regulation where they do not pose an unacceptable risk to consumers when used in food-producing animals of the equine species and a sixmonth withdrawal period is respected. 

(6) A substance only qualifies as an “essential substance” where no satisfactory alternative for the treatment or diagnosis of an indication is available and where the condition would, if untreated, create unnecessary suffering for the animal. A substance only qualifies as “bringing added clinical benefit” where it provides a clinically relevant advantage based on improved efficacy or safety or a major contribution to treatment or diagnosis. This may be the result, inter alia, of different modes of action, different pharmacokinetic or pharmacodynamic profiles, different lengths of treatment or different routes of administration. 

(7) At the request of the Commission, the European Medicines Agency (“the Agency”) carried out a scientific evaluation of the substances listed in the Annex to Commission Regulation (EC) No 1950/2006, as well as of the substances that were identified in a survey among the competent authorities and relevant stakeholders. In its scientific advice, the Agency identifies some of those substances as “essential” or as “bringing added clinical benefit” and for which a withdrawal period of six months would not pose an unacceptable risk for consumers. 

(8) In line with the Agency’s advice, the substances recommended as essential or as bringing added clinical benefit should be used for the specific diseases or conditions, treatment or diagnostic needs specified in the Annex to this Regulation. In addition, the Agency advised that consideration should also be given to the alternatives listed in that Annex. 

(9) The substances listed in Tables 1 or 2 in the Annex to Commission Regulation (EU) No 37/2010, or substances prohibited for use in stockfarming by Council Directive 96/22/EC, do not qualify as essential or bringing added clinical benefit. Therefore, in the event that substances listed in the Annex to this Regulation are also included in Tables 1 or 2 in the Annex to Commission Regulation (EU) No 37/2010, or their use in food-producing animals of the equine species is prohibited by Union legislation, these substances should no longer be used for the purposes of this Regulation. 

(10) The list of substances set out in the Annex to this Regulation should replace the list provided for under Commission Regulation (EC) No 1950/2006. Commission Regulation (EC) No 1950/2006 should be repealed. In order to allow the competent authorities, veterinarians, and animal keepers concerned to adapt to the changes resulting from the non-inclusion in the Annex to this Regulation of some substances or indications listed in the Annex to Commission Regulation (EC) No 1950/2006, a sufficient transitional period should be allowed. 

(11) In order to increase the availability of medicinal products to food-producing animals of the equine species and avoid unacceptable suffering, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation should also apply as from the date of its entry into force. 

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