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Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance)

article  3

CELEX:  02004L0009-20190726

1. Member States shall designate the authorities responsible for the inspection of laboratories within their territories and for the audit of studies carried out by laboratories to assess compliance with GLP.
2. The authorities referred to in paragraph 1 shall inspect the laboratory and audit the studies in accordance with the provisions laid down in Annex I.