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委员会实施决定(EU) 2016/1235，批准韩国本土实验室进行血清学测试，以监测狂犬病疫苗在狗、猫和雪貂的有效性(通报文件号C(2016) 4665)

技术法规类型：欧盟Eurlex法规来源：tbtmap

EURLEX ID：32016D1235

OJ编号：OJ L 202, 28.7.2016, p. 43-44

中文标题：委员会实施决定(EU) 2016/1235，批准韩国本土实验室进行血清学测试，以监测狂犬病疫苗在狗、猫和雪貂的有效性(通报文件号C(2016) 4665)

原文标题：Commission Implementing Decision (EU) 2016/1235 of 26 July 2016 authorising a laboratory in the Republic of Korea to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets (notified under document C(2016) 4665) (Text with EEA relevance)

分类：03.50.30_动物健康与畜牧学

文件类型：二级立法 Decision|决定

生效日期：1001-01-01

废止日期：2058-12-31

法规全文：查看欧盟官方文件

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28.7.2016

Official Journal of the European Union

L 202/43

COMMISSION IMPLEMENTING DECISION (EU) 2016/1235

of 26 July 2016

authorising a laboratory in the Republic of Korea to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets

(notified under document C(2016) 4665)

(Text with EEA relevance)

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, as the specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines. The AFSSA has now been integrated into the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES) in France.

(2)	Decision 2000/258/EC provides, inter alia, that the ANSES is to appraise laboratories in third countries that have applied for approval to carry out serological tests to monitor the effectiveness of rabies vaccines.

(3)

The authorisation granted on 9 February 2007 in accordance with Decision 2000/258/EC to Choong Ang Vaccine laboratory in Daejeon has been withdrawn in accordance with Commission Decision 2010/436/EU (2) following the unfavourable appraisal report dated 29 September 2015 established by the ANSES for this laboratory and submitted to the Commission.

(4)	The competent authority of the Republic of Korea has submitted an application for re-approval of Choong Ang Vaccine laboratory in Daejeon, and the ANSES has established and submitted to the Commission a favourable appraisal report dated 21 March 2016 for this laboratory.

(5)	This laboratory should therefore be authorised to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets.

(6)	The measures provided for in this Decision are in accordance with the opinion of 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 laboratory is hereby authorised to perform serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets:

Choong Ang Vaccine laboratory

1476-37 Yuseong-daero Yuseong-gu

Daejeon, 34055

Republic of Korea

Article 2

This Decision shall apply from 1 August 2016.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 26 July 2016.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

(1) OJ L 79, 30.3.2000, p. 40.

(2) Commission Decision 2010/436/EU of 9 August 2010 implementing Council Decision 2000/258/EC as regards proficiency tests for the purposes of maintaining authorisations of laboratories to carry out serological tests to monitor the effectiveness of rabies vaccines (OJ L 209, 10.8.2010, p. 19).

附件:

P020171219824536709542.pdf