Article 2

Essential substances may be used, for the specific disease conditions, treatment needs or zootechnical purposes specified in the Annex, where no medicinal product authorised for equidae or referred to in Article 11 of Directive 2001/82/EC would yield equally satisfactory results in terms of successfully treating the animal, avoiding unnecessary suffering for the animal, or ensuring the safety of those treating the animal.

F1Substances bringing added clinical benefit may be used, for the specific disease conditions, treatment needs or zootechnical purposes specified in the Annex, where they provide a clinically relevant advantage based on improved efficacy or safety or a major contribution to treatment compared to medicinal products authorised for equidae or referred to in Article 11 of Directive 2001/82/EC.

For the purposes of the first and second subparagraphs, the alternatives listed in the Annex shall be considered.