6 October 2016 EMA/CVMP/615777/2016 Committee for Medicinal Products for Veterinary Use
Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits Procedure no: EMEA/V/MRL/004380/FULL/0001 Name of the substance: Fluralaner (INN) Basis for the opinion Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Intervet International B.V. submitted to the European Medicines Agency on 21 December 2015 an application for the establishment of maximum residue limits for fluralaner in chicken. On 19 May 2016 the Committee for Medicinal Products for Veterinary Use adopted a list of questions to be addressed by the applicant. The response to the list of questions was submitted on 8 July 2016.
Recommendation The Committee, having considered the application and having evaluated the response to the list of questions, recommends by consensus the establishment of maximum residue limits for fluralaner in chicken tissues and eggs. Furthermore, and with reference to Article 5 of Regulation (EC) No 470/2009, the Committee agreed to extrapolate the maximum residue limits recommended in chicken tissues and eggs to tissues and eggs of other poultry species. Therefore, the Committee recommends by consensus the establishment of maximum residue limits for fluralaner in accordance with the following table: Pharmaco-
Marker
Animal
logically
residue
species
Fluralaner
Poultry
MRLs
Target tissues
Other
Therapeutic
provisions
classification
NO ENTRY
Antiparasitic
active substance Fluralaner
65 µg/kg 650 µg/kg
Muscle Skin and fat in
agents /
natural
Agents against
proportions
ectoparasites
650 µg/kg
Liver
420 µg/kg
Kidney
1300 µg/kg
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Eggs
An agency of the European Union
The Icelandic and Norwegian CVMP members agree with the above-mentioned recommendation of the Committee. The scientific conclusions of the Committee are presented in the European public MRL assessment report (EPMAR), provided in Annex I of this opinion. The analytical method for monitoring of residues is appended to this opinion. The present opinion is forwarded to the European Commission and to the applicant together with its appendices. London, 6 October 2016
Signature on file
Dr D. Murphy Chair, on behalf of the CVMP
Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits EMA/CVMP/615777/2016
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Annex I European public MRL assessment report (EPMAR)
Opinion of the Committee for Medicinal Products for Veterinary Use on ...
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