Article 2U.K.
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.]
Textual Amendments
F1 Substituted by Commission Regulation (EU) No 122/2013 of 12 February 2013 amending Regulation (EC) No 1950/2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae (Text with EEA relevance).