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.
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04
CitationArticle 12 of Commission Regulation (EC) No 378/2005 (LawPlayer, data as of 2026-07-04)