COMMISSION IMPLEMENTING DECISION
of 31 July 2014
authorising laboratories in the Republic of Korea to carry out serological tests to monitor the effectiveness of rabies vaccines
(notified under document C(2014) 5352)
(Text with EEA relevance)
(2014/514/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Decision 2000/258/EC of 20 March 2000 designating a specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines (1), and in particular Article 3(2) thereof,
Whereas:
(1)
Decision 2000/258/EC designates the Agence française de sécurité sanitaire des aliments (AFSSA) in Nancy, France (integrated since 1 July 2010 into the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, ANSES), as the specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines.
(2)
That Decision provides that the ANSES is to document the appraisal of laboratories in third countries that have applied to carry out serological tests to monitor the effectiveness of rabies vaccines.
(3)
The competent authority of the Republic of Korea has submitted an application for approval of the laboratory KBNP, INC in Sinam-myeon which is supported by a favourable appraisal report established for that laboratory by the ANSES dated 16 September 2013.
(4)
Following the unfavourable appraisal report established by the ANSES dated 16 September 2013, the authorisation granted on 1 March 2011 in accordance with Decision 2000/258/EC to the laboratory Komipharm International Co. Ltd in Siheung-si has been withdrawn in accordance with Commission Decision 2010/436/EU (2).
(5)
The competent authority of the Republic of Korea has submitted an application for re-approval of the laboratory Komipharm International Co. Ltd in Siheung-si which is supported by a favourable appraisal report established for that laboratory by the ANSES dated 24 April 2014.
(6)
Those laboratories should therefore be authorised to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets.
(7)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:
Article 1
In accordance with Article 3(2) of Decision 2000/258/EC, the following laboratories are authorised to perform the serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets:
(a)
KBNP, INC
235-9, Chusa-ro, Sinam-myeon
Yesan-gun, Chungcheongnam-do
Republic of Korea
(b)
Komipharm International Co. Ltd
17 Gyeongje-ro,
Siheung-si, Gyeonggi-do,
429-848
Republic of Korea
Article 2
This Decision shall apply from 15 August 2014.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 31 July 2014.