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)

The list of substances essential for the treatment of equidae, hereinafter ‘essential substances’, applicable by way of derogation from Article 11 of Directive 2001/82/EC, is set out in the Annex to this Regulation.

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. For the purposes of the first paragraph, the alternatives listed in the Annex shall be considered.

1 Essential substances may be used only in accordance with Article 10(1) of Directive 2001/82/EC.

2 The details of a treatment with essential substances must be recorded in accordance with the instructions laid down in Section IX of the identification document for equidae set out in Decisions 93/623/EC and 2000/68/EC.

Any substance that is entered in one of the lists in Annexes I to IV to Regulation (EC) No 2377/90, or the use of which for equidae is prohibited by Community legislation, shall no longer be used as an essential substance for the purposes of this Regulation.

1 The European Medicines Agency shall, at the request of the Commission, ensure that the Committee for Medicinal Products for Veterinary Use carries out a scientific evaluation of any draft amendment to the list set out in the Annex. 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.

2 When Member States or veterinary professional associations ask the Commission to amend the list set out in the Annex they shall duly substantiate their request and include any relevant scientific data available.

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