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

 

SUMMARY OF:

Directive 2004/9/EC on the inspection and verification of good laboratory practice (GLP)

WHAT IS THE AIM OF THE DIRECTIVE?

• It codifies and repeals Directive 88/320/EEC on the inspection and verification of Good Laboratory Practice (GLP).
• It was adopted at the same time as Directive 2004/10/EC (see summary) which lays down the rules on the application of the principles of GLP and the verification of their applications for tests. Directive 2004/9/EC 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 humans, animals and the environment.

KEY POINTS

• Each EU country designates the authorities responsible for the inspection of laboratories within its territory.
• Each year, the EU countries forward a report to the European Commission and to a committee set up under the directive, listing the laboratories inspected, the date of the inspection and the conclusions of the inspection.
• Where a laboratory passes the inspection, the EU country in question is the guarantor that the laboratory is GLP-compliant and this GLP compliance must be recognised throughout the EU.
• If an EU country considers that a laboratory within its territory claiming GLP compliance does not in fact comply, it must inform the Commission, which must inform the other EU countries. Likewise, an EU country may also request a study audit, possibly in conjunction with a new inspection, of laboratories located in another EU country.
• The annexes to the directive include detailed practical guidance to EU countries on the structure, mechanisms and procedures they should adopt when establishing national GLP compliance monitoring programmes so that these programmes are internationally acceptable.

FROM WHEN DOES THE DIRECTIVE APPLY?

It has applied since 11 March 2004. Directive 2004/9/EC codified and replaced Directive 88/320/EEC which had to become law in the EU countries by 1989.

BACKGROUND

For more information, see:

• Good Laboratory Practice (European Commission).

MAIN DOCUMENT

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) (OJ L 50, 20.2.2004, pp. 28-43)

Successive amendments to Directive 2004/9/EC have been incorporated into the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

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 (OJ L 396, 30.12.2006, pp. 1-849). Text republished in corrigendum (OJ L 136, 29.5.2007, pp. 3-280)

See consolidated version.

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (OJ L 50, 20.2.2004, pp. 44-59)

See consolidated version.

last update 24.10.2019