My bookmarksSign up free

Directive 2004/9/EC of the European Parliament and of the… Article 6

Directive 2004/9/EC of the European Parliament and of the… Article 6

Article 6

1. Where a Member State has sufficient reason to believe that a laboratory in another Member State claiming GLP compliance has not carried out a test in accordance with GLP, it may request further information from that Member State and in particular may request a study audit, possibly in conjunction with a new inspection. Should it not be possible for the Member States concerned to reach agreement, the Member States in question shall immediately inform the other Member States and the Commission, giving reasons for their decision. 2. The Commission shall examine as soon as possible the reasons put forward by the Member States within the Committee referred to in Article 7(1); it shall then take the appropriate measures in accordance with procedure referred to in Article 7(2). It may in this connection ask for expert opinions from the designated authorities in the Member States. 3. If the Commission considers that amendments to this Directive are necessary in order to resolve the matters referred to in paragraph 1, it shall initiate the procedure referred to in Article 7(2) with a view to adopting those amendments.

Read the full instrument →

Other provisions in Directive 2004/9/EC of the European Parliament and of the…

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 Directive 2004/9/EC of the European Parliament and of the… (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.

What to look at next