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Commission Directive 2005/28/EC of 8 April 2005 laying down… Article 6

Commission Directive 2005/28/EC of 8 April 2005 laying down… Article 6

Article 6

1.   Each Ethics Committee established under Article 6(1) of Directive 2001/20/EC shall adopt the relevant rules of procedure necessary to implement the requirements set out in that Directive and, in particular, in Articles 6 and 7 thereof. 2.   The Ethics Committees shall, in every case, retain the essential documents relating to a clinical trial, as referred to in Article 15(5) of Directive 2001/20/EC, for at least three years after completion of that trial. They shall retain the documents for a longer period, where so required under other applicable requirements. 3.   Communication of information between the Ethics Committees and the competent authorities of the Member States shall be ensured through appropriate and efficient systems.

Read the full instrument → · Read this in context: SECTION 2 — THE ETHICS COMMITTEE →

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 6 of Commission Directive 2005/28/EC of 8 April 2005 laying down… (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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