Commission Regulation (EC) No 378/2005 CHAPTER III — TESTING AND VALIDATION OF METHODS OF ANALYSIS, REPORTING AND GUIDANCE

Article 10–Article 12 · 3 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Testing of methods of analysis and validation of methods of analysis

Article 10

1. The CRL shall indicate in its evaluation report to the Authority, as provided for in Article 5(2), and shall inform the applicant and the Commission, if it considers that the following are necessary: (a) testing of methods of analysis; (b) validation of methods of analysis. In doing so, the CRL shall provide the applicant with a document describing the work to be carried out through the consortium including a time schedule and an estimate of a special fee to be paid by the applicant. The applicant shall inform the CRL about his agreement to the document within 15 days of receipt of the communication. 2. The CRL shall supplement the report to the Authority, as provided for in Article 5(1), with an addendum concerning the outcome of the application of the procedure foreseen in paragraph 1 within 30 days of the availability to the CRL of the results of the testing and validation work.

Reporting

Article 11

The CRL shall be responsible for preparing an annual report on each year’s activities carried out for the implementation of this Regulation and shall submit it to the Commission. The consortium shall contribute to this annual report. The CRL may also organise an annual meeting with the consortium, in view of the establishment of the annual report.

Guidance

Article 12

1. The CRL may establish detailed guidance for applicants concerning: (a) reference samples; (b) the testing of methods of analysis, including in particular criteria about when such testing may be required; (c) the validation of methods of analysis, including in particular criteria about when such validation may be required. 2. The CRL shall establish detailed guidance for laboratories, including criteria for appointing rapporteur laboratories.

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