# L_2013152EN.01005001.xml

| 5.6.2013 | EN | Official Journal of the European Union | L 152/50 |
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5.6.2013

EN

Official Journal of the European Union

L 152/50

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COMMISSION IMPLEMENTING DECISION

of 3 June 2013

authorising a laboratory in Ukraine to carry out serological tests to monitor the effectiveness of rabies vaccines

(notified under document C(2013) 3193)

(Text with EEA relevance)

(2013/261/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. |
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(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. |
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(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) | Following the unfavourable appraisal report established by the ANSES dated 3 September 2012, the authorisation granted on 30 January 2006 in accordance with Decision 2000/258/EC to the Central State Laboratory of Veterinary Medicine in Kiev has been withdrawn in accordance with 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 (2). |
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(3)

Following the unfavourable appraisal report established by the ANSES dated 3 September 2012, the authorisation granted on 30 January 2006 in accordance with Decision 2000/258/EC to the Central State Laboratory of Veterinary Medicine in Kiev has been withdrawn in accordance with 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 (2).

| (4) | The competent authority of Ukraine has submitted an application for reapproval of the Central State Laboratory of Veterinary Medicine in Kiev which is supported by a favourable appraisal report established for that laboratory by the ANSES dated 6 March 2013. |
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(4)

The competent authority of Ukraine has submitted an application for reapproval of the Central State Laboratory of Veterinary Medicine in Kiev which is supported by a favourable appraisal report established for that laboratory by the ANSES dated 6 March 2013.

| (5) | The competent authority of Ukraine has also officially informed the Commission that the name of the laboratory has changed. |
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(5)

The competent authority of Ukraine has also officially informed the Commission that the name of the laboratory has changed.

| (6) | That laboratory should therefore be authorised to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets. |
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(6)

That laboratory 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 the Food Chain and Animal Health, |
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(7)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

In accordance with Article 3(2) of Decision 2000/258/EC, the following laboratory is authorised to perform the serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets:

| State Research Institute of Laboratory Diagnostics and Veterinary Sanitary Expertise |
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| 30, Donetskaya st. |
| Kiev 03151 |
| Ukraine |

State Research Institute of Laboratory Diagnostics and Veterinary Sanitary Expertise

30, Donetskaya st.

Kiev 03151

Ukraine

Article 2

This Decision shall apply from 15 June 2013.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 3 June 2013.

For the Commission

Tonio BORG

Member of the Commission

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

1

(2)  
  OJ L 209, 10.8.2010, p. 19.

2

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