Commission Implementing Regulation (EU) 2025/901 of 19 May 2025 establishing 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 and repealing Regulation (EC) No 1950/2006

The list of substances referred to in Article 115(5) of Regulation (EU) 2019/6 is set out in the Annex to this Regulation.

1 Substances which are essential for the treatment of equine species may be used for the indications specified in the Annex to this Regulation, where no veterinary medicinal product authorised for food-producing animals of the equine species or no medicinal product referred to in Article 113 of Regulation (EU) 2019/6 would yield equally satisfactory results in terms of successfully treating the animal or avoiding unnecessary suffering for the animal.

2 Substances which bring added clinical benefit compared to other treatment options may be used for the indications specified in the Annex to this Regulation and taking into account the alternatives listed in that Annex, where they provide a clinically relevant advantage based on improved efficacy or safety or a major contribution to treatment compared to veterinary medicinal products authorised for food-producing animals of the equine species or to medicinal products referred to in Article 113 of Regulation (EU) 2019/6.

3 Where any of the substances listed in the Annex to this Regulation are entered in Tables 1 or 2 of the Annex to Regulation (EU) No 37/2010, or their use in food-producing animals of the equine species is prohibited by Union legislation, such substances shall no longer be used for the purposes of this Regulation.

1 Regulation (EC) No 1950/2006 is repealed with effect from 21 May 2027.

2 References to the repealed Regulation (EC) No 1950/2006 shall be construed as references to this Regulation.

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 21 May 2025.