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Commission Regulation (EC) No 378/2005 Article 12

Commission Regulation (EC) No 378/2005 Article 12

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.

Read the full instrument → · Read this in context: CHAPTER III — TESTING AND VALIDATION OF METHODS OF ANALYSIS, REPORTING AND GUIDANCE →

Other provisions in CHAPTER III — TESTING AND VALIDATION OF METHODS OF ANALYSIS, REPORTING AND GUIDANCE

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)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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