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Good laboratory practice: inspection and verification of laboratory studies on all chemicals

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Good laboratory practice: inspection and verification of laboratory studies on all chemicals

This directive makes provision for a verification procedure for laboratories claiming to use Good Laboratory Practice (GLP) in conducting tests on chemicals.

ACT

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) [See amending act(s)].

SUMMARY

This Directive amends and repeals Directive 88/320/EEC on the inspection and verification of Good Laboratory Practice.

It applies to the inspection and verification of the organisational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals (e.g. cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) in order to assess the effect of such products on man, animals and the environment.

Each Member State designates the authorities responsible for the inspection of laboratories within its territory.

Each year, the Member States forward to the Commission and to a Committee set up by the Directive a report listing the laboratories inspected, the date of the inspection and the conclusions of the inspection.

If the inspection is positive, the Member State is the guarantor that the laboratory is GLP-compliant and this decision is binding in the other Member States.

If a Member State considers that a laboratory within its territory claiming GLP compliance does not in fact comply, it shall inform the Commission, which shall inform the other Member States. Similarly, a Member State may also request a study audit, possibly in conjunction with a new inspection, of laboratories located in another Member State.

The Annexes to the Directive include a detailed description of the procedures to be followed in monitoring GLP compliance in order to ensure that these are internationally acceptable.

References

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 2004/9/EC

11.03.2004

-

OJ L 50 of 20.02.2004

Amending act(s)

Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EC) No 219/2009

20.4.2009

-

OJ L 87 of 31.3.2009

Successive amendments and corrections to Directive 219/2009 have been incorporated in the basic text. This consolidated version is for reference purpose only.

RELATED ACTS

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [Official Journal L 396 of 30.12.2006].

See consolidated version

Last updated: 12.11.2010

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