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    188宝金博页面版: Substances considered as not falling within the scope …

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    内容提示： 18 February 2016 EMA/CVMP/519714/2009–Rev.33 Committee for Medicinal Products for Veterinary Use Substances considered as not falling within the scope of Regulation (EC) No. 470/20091 , with regard to residues of veterinary medicinal products in foodstuffs of animal origin 1. Background information Regulation (EC) No. 470/2009 of 6 May 2009 lays down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. The Regulation repeale...

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    18 February 2016 EMA/CVMP/519714/2009–Rev.33 Committee for Medicinal Products for Veterinary Use Substances considered as not falling within the scope of Regulation (EC) No. 470/20091 , with regard to residues of veterinary medicinal products in foodstuffs of animal origin 1. Background information Regulation (EC) No. 470/2009 of 6 May 2009 lays down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. The Regulation repealed Council Regulation (EEC) No. 2377/90. Article 1(a) of Regulation (EC) No. 470/2009 defines its scope as follows: “For the purposes of ensuring food safety, this Regulation lays down rules and procedures in order to establish: a) the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin (maximum residue limit); (…)” Article 1(3) of the Regulation states that: “This Regulation shall not apply to 'active principles of biological origin intended to produce active or passive immunity or to diagnose a state of immunity, used in immunological veterinary medicinal products'.” In Article 2(a) it is specified that “residues of pharmacologically actives substances” means all pharmacologically active substances, expressed in mg/kg or μg/kg on a fresh weight basis, whether active substances, excipients or degradation products, and their metabolites which remain in food obtained from animals. Previously, in the context of the evaluation of MRL applications under Council Regulation (EC) No. 2377/90, the CVMP discussed the concept of “pharmacologically active substances”, in particular considering the need for MRL evaluations for excipients and manufacturing materials. As detailed in the CVMP publication entitled Position Paper on the definition of substances capable of pharmacological action in the context of Directive 2001/82/EC, as amended, with a particular reference to excipients 1 Regulation (EC) No. 470/2009 of the European Parliament and of the Council of 6 May 2009, repealing Council Regulation (EEC) No. 2377/90 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union Telephone + 44 (0)20 3660 6000 Facsimile + 44 (0)20 3660 5555 Send a question via our w ebsite www.ema.europa.eu/contact © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

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