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
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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 3
1 Essential substances and substances bringing added clinical benefit shall be used only in accordance with Article 10(1) of Directive 2001/82/EC.
2 The details of a treatment with essential substances shall be recorded in accordance with the instructions laid down in Section IX of the identification document for equidae set out in Commission Regulation (EC) No 504/2008 .
Article 4
Any substance that is entered in one of the lists in the Annex to Commission Regulation (EU) No 37/2010 , or the use of which for equidae is prohibited by Union legislation, shall no longer be used for the purposes of this Regulation.
Article 2
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
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