Commission Regulation (EC) No 1950/2006 of 13 December 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)

Article 1

The list of substances essential for the treatment of equidae, hereinafter ‘essential substances’, as well as of substances which bring added clinical benefit compared to other treatment options available for equidae, hereinafter ‘substances bringing added clinical benefit’, applicable by way of derogation from Article 11 of Directive 2001/82/EC, is set out in the Annex to this Regulation.

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.

Substances 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.

Article 3

Article 4

Any substance that is entered in one of the lists in the Annex to Commission Regulation (EU) No 37/2010 (⁸), or the use of which for equidae is prohibited by Union legislation, shall no longer be used for the purposes of this Regulation.

Article 5

Within 210 days of receiving such a request, the European Medicines Agency shall deliver an opinion to the Commission on the scientific suitability of the amendment.

Where appropriate, the European Food Safety Authority shall also be consulted.

Article 6

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

List of substances essential for the treatment of equidae and substances bringing added clinical benefit compared to other treatment options available for equidae

The withdrawal period for each of the substances on the following list shall be six months.