2010/436/EU: Commission Decision 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 (notified under document C(2010) 5421) Text with EEA relevance

1 Each laboratory in a Member State or a third country which is authorised for carrying out serological tests to monitor the effectiveness of rabies vaccines in accordance with Article 3(1) and (2) of Decision 2000/258/EC shall undergo a proficiency test each year.

2 That proficiency test shall be carried out by the laboratory of the Agence française de sécurité sanitaire des aliments de Nancy (‘AFSSA, Nancy’).

3 Following each proficiency test as referred to in paragraph 1, AFSSA, Nancy shall submit, at the latest by 31 October of the same year, the respective appraisal report to: (a) the corresponding laboratory which underwent the proficiency test; (b) the competent authority of the Member State; where the laboratory referred to in point (a) is located, in the case of a laboratory authorised in accordance with Article 3(1) of Decision 2000/258/EC; (c) the Commission, in the case of a laboratory referred to in point (a) authorised in accordance with Article 3(2) of Decision 2000/258/EC.

4 By way of derogation from the deadline referred to in paragraph 3, an unfavourable report shall be submitted within 30 days after the appraisal.

The authorisation granted to a laboratory in a Member State in accordance with Article 3(1) of Decision 2000/258/EC shall be maintained provided that the appraisal report established by AFSSA, Nancy following the proficiency test provided for in Article 1 is favourable.

The authorisation granted to a laboratory in a third country in accordance with Article 3(2) of Decision 2000/258/EC shall be maintained provided that the appraisal report established by AFSSA, Nancy following the proficiency test provided for in Article 1 is favourable.

1 From 1 January 2011, AFSSA, Nancy shall charge each laboratory a fee for taking part in the proficiency tests provided for in Article 1.

2 That fee shall be fixed by AFSSA, Nancy taking into account the criteria for the calculation of fees or charges set out in Annex VI to Regulation (EC) No 882/2004.

Decision 2004/233/EC is repealed.

This Decision is addressed to the Member States.